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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-018407-28 | EudraCT Number |
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The purpose of this trial is to assess the effect of asenapine 2.5 and 5 mg sublingually twice daily (BID) compared with placebo in the treatment of schizophrenia (overall symptoms) as measured by the Positive and Negative Syndrome Scale (PANSS). Olanzapine administered 15 mg orally once daily (QD) was used as an active control. The primary hypothesis is that at least one of the asenapine doses is superior to placebo in improving schizophrenia symptoms as measured by the change from Baseline in the PANSS total score at Day 42. The first key secondary hypothesis is that at least one of the asenapine doses is superior to placebo in improving schizophrenia symptoms as measured by the change from Baseline in Clinical Global Impression Scale-Severity (CGI-S) score at Day 42. The second key secondary hypothesis is that at least one of the asenapine doses is superior to placebo in improving schizophrenia symptoms as measured by the rate of PANSS responders (≥30% Reduction From Baseline in PANSS Total Score) at Day 42.
The trial consists of a screening/tapering period, treatment period, and follow-up period. The 6-week active treatment period includes an inpatient phase and outpatient phase. Participants who complete the trial may continue treatment under a long-term extension protocol (P05689). Participants who do not continue in the treatment continuation trial (whether they complete the 6-week trial or discontinue prematurely) will have a follow-up visit 7 days after their last dose of trial medication.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Asenapine 2.5 mg BID | Experimental |
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| Asenapine 5 mg BID | Experimental |
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| Olanzapine 15 mg QD | Active Comparator |
| |
| Placebo BID | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Asenapine | Drug | 2.5 mg or 5 mg fast dissolving active asenapine tablets administered sublingually |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in PANSS Total Score at Day 42 | The PANSS is a 30-item clinician-rated instrument for assessing schizophrenia symptoms. It consists of 3 subscales: positive subscale (7 items), negative subscale (7 items), and general psychopathology subscale (16 items). For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The PANSS total score for each participant was sum of the rating assigned to each of the 30 PANSS items, and ranged from 30 to 210 with a higher score indicating greater severity of symptoms. The reported measure is the change from baseline at Day 42; improvement in symptoms is represented by negative values. | Baseline and Day 42 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in CGI-S Score at Day 42 | Change from baseline in CGI-S score at Day 42 is a Key Secondary Outcome Measure. CGI-S is a 7-point scale for assessing the global severity of the participant's illness, with ratings from 1=normal, not ill to 7=very severely ill. The reported measure is the change from baseline at Day 42; improvement in symptoms is represented by negative values. | Baseline and Day 42 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27821210 | Result | Landbloom R, Mackle M, Wu X, Kelly L, Snow-Adami L, McIntyre RS, Mathews M, Hundt C. Asenapine for the treatment of adults with an acute exacerbation of schizophrenia: results from a randomized, double-blind, fixed-dose, placebo-controlled trial with olanzapine as an active control. CNS Spectr. 2017 Aug;22(4):333-341. doi: 10.1017/S1092852916000377. Epub 2016 Nov 8. |
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One participant randomized to asenapine 2.5 mg BID did not receive study drug but was recorded in clinical database as completing the study. In Participant Flow table, this participant is presented as Not Completed in period "Randomization through Start Treatment" (Not Treated).
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| ID | Title | Description |
|---|---|---|
| FG000 | Asenapine 2.5 mg BID | Participants were administered one 2.5 mg asenapine tablet twice daily (BID) for 42 days |
| FG001 | Asenapine 5 mg BID | Participants were administered one 5 mg asenapine tablet BID for 42 days |
| FG002 | Olanzapine 15 mg QD | Participants were administered 15 mg olanzapine (as one 10 mg and one 5 mg tablet) once daily (QD) for 42 days, except during Week 1 olanzapine 10 mg QD was administered |
| FG003 | Placebo BID | Participants were administered placebo tablets BID for 42 days |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Randomization Through Start Treatment |
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| Treatment Through Study Completion |
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All randomized participants who received ≥1 dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Asenapine 2.5 mg BID | Participants were administered one 2.5 mg asenapine tablet BID for 42 days |
| BG001 | Asenapine 5 mg BID | Participants were administered one 5 mg asenapine tablet BID for 42 days |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in PANSS Total Score at Day 42 | The PANSS is a 30-item clinician-rated instrument for assessing schizophrenia symptoms. It consists of 3 subscales: positive subscale (7 items), negative subscale (7 items), and general psychopathology subscale (16 items). For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The PANSS total score for each participant was sum of the rating assigned to each of the 30 PANSS items, and ranged from 30 to 210 with a higher score indicating greater severity of symptoms. The reported measure is the change from baseline at Day 42; improvement in symptoms is represented by negative values. | FAS, defined as randomized participants who received ≥1 dose of study drug and had both a baseline and ≥1 post-baseline PANSS Total Score | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline and Day 42 |
|
Up to 30 days after last dose of study drug (Up to approximately 10 weeks)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Asenapine 2.5 mg BID | Participants were administered one 2.5 mg asenapine tablet BID for 42 days |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C522667 | asenapine |
| D000077152 | Olanzapine |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Placebo Asenapine | Drug | Fast dissolving placebo asenapine tablets (to match 2.5 mg and 5 mg active asenapine tablets) administered sublingually |
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| Olanzapine | Drug | 5 and 10 mg film-coated active olanzapine tablets administered orally QD. The time of the active olanzapine dose (either morning or evening) is not disclosed in order to preserve blinding |
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| Placebo Olanzapine | Drug | Film-coated placebo olanzapine tablets (to match 5 and 10 mg active olanzapine tablets) administered orally |
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| Percentage of Participants Who Are PANSS Responders (≥30% Reduction From Baseline in PANSS Total Score) at Day 42 | Rate of PANSS responders at Day 42 is a Key Secondary Outcome Measure. A PANSS responder was defined as a participant who had a reduction from baseline of at least 30% in the PANSS total score at a post-baseline assessment. The PANSS is a 30-item clinician-rated instrument for assessing schizophrenia symptoms. For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The Total score is the sum of the ratings for the individual items, and ranged from 30 to 210 with a higher score indicating greater severity of symptoms. Missing data were imputed by Last Observation Carried Forward (LOCF). | Baseline and Day 42 |
| Change From Baseline in Body Weight at Day 42 | Change from baseline in body weight at Day 42 is the Key Safety Outcome Measure. | Baseline and Day 42 |
| Change From Baseline in PANSS Total Score at Days 4, 7, 14, 21, 28 and 35 | The PANSS is a 30-item clinician-rated instrument for assessing schizophrenia symptoms. It consists of 3 subscales: positive subscale (7 items), negative subscale (7 items), and general psychopathology subscale (16 items). For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The PANSS total score for each participant was sum of the rating assigned to each of the 30 PANSS items, and ranged from 30 to 210 with a higher score indicating greater severity of symptoms. The reported measure is the change from baseline; improvement in symptoms is represented by negative values. | Baseline and Days 4, 7, 14, 21, 28 and 35 |
| Percentage of Participants Who Are PANSS Responders (≥30% Reduction From Baseline in PANSS Total Score) at Days 4, 7, 14, 21, 28 and 35 | A PANSS responder was defined as a participant who had a reduction from baseline of at least 30% in the PANSS total score at a post-baseline assessment. The PANSS is a 30-item clinician-rated instrument for assessing schizophrenia symptoms. For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The Total score is the sum of the ratings for the individual items, and ranged from 30 to 210 with a higher score indicating greater severity of symptoms. Missing data were imputed by LOCF. | Days 4, 7, 14, 21, 28 and 35 |
| Change From Baseline in CGI-S Score at Days 4, 7, 14, 21, 28 and 35 | CGI-S is a 7-point scale for assessing the global severity of the participant's illness, with ratings from 1=normal, not ill to 7=very severely ill. The reported measure is the change from baseline; improvement in symptoms is represented by negative values. | Baseline and Days 4, 7, 14, 21, 28 and 35 |
| Percentage of Participants Who Are Clinical Global Impression Scale-Improvement (CGI-I) Responders at Days 4, 7, 14, 21, 28, 35 and 42 | A CGI-I responder was defined as a participant who had a CGI-I score of 1 (very much improved) or 2 (much improved) at a post-baseline assessment. CGI-I is a 7-point scale for assessing the global improvement of the participant's illness relative to baseline, with ratings from 1=very much improved to 7=very much worse. Missing data were imputed by LOCF. | Days 4, 7, 14, 21, 28, 35 and 42 |
| Change From Baseline in PANSS Negative Subscale Score at Days 4, 7, 14, 21, 28, 35 and 42 | This measure reports results for the 7 items of the negative subscale of the PANSS, which is a 30-item clinician-rated instrument used to assess schizophrenia symptoms. Negative symptoms represent a diminution or loss of normal functions (e.g., emotional withdrawal). For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. PANSS negative subscale score for each participant was sum of the rating assigned to each of the 7 subscale items, and ranged from 7 to 49 with a higher score indicating greater severity of symptoms. Measure reports change from baseline; improvement in symptoms is represented by negative values. | Baseline and Days 4, 7, 14, 21, 28, 35 and 42 |
| Change From Baseline in PANSS Positive Subscale Score at Days 4, 7, 14, 21, 28, 35 and 42 | This measure reports results for the 7 items of the positive subscale of the PANSS, which is a 30-item clinician-rated instrument used to assess schizophrenia symptoms. Positive symptoms refer to an excess or distortion of normal mental status (e.g., delusions). For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. PANSS positive subscale score for each participant was sum of the rating assigned to each of the 7 subscale items, and ranged from 7 to 49 with a higher score indicating greater severity of symptoms. Measure reports change from baseline; improvement in symptoms is represented by negative values. | Baseline and Days 4, 7, 14, 21, 28, 35 and 42 |
| Change From Baseline in PANSS General Psychopathology Subscale Score at Days 4, 7, 14, 21, 28, 35 and 42 | This measure reports results for the 16 items of the general psychopathology subscale of the PANSS, which is a 30-item clinician-rated instrument used to assess the symptoms of schizophrenia. For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The PANSS general psychopathology subscale score for each participant was calculated as the sum of the rating assigned to each of the 16 subscale items, and ranged from 16 to 112 with a higher score indicating greater severity of symptoms. The reported measure is the change from baseline; improvement in symptoms is represented by negative values. | Baseline and Days 4, 7, 14, 21, 28, 35 and 42 |
| Change From Baseline in PANSS Marder Factor Positive Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42 | This measure reports results for the 8 items of the Marder positive symptom factor of the PANSS, which is a 30-item clinician-rated instrument used to assess schizophrenia symptoms. Marder factors are a modified grouping of the 30 PANSS items. For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. PANSS Marder factor positive symptom score for each participant was sum of rating assigned to each of the 8 applicable Marder factor items, and ranged from 8 to 56 with a higher score indicating greater severity of symptoms. Measure reports change from baseline; improvement in symptoms is represented by negative values. | Baseline and Days 4, 7, 14, 21, 28, 35 and 42 |
| Change From Baseline in PANSS Marder Factor Negative Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42 | This measure reports results for the 7 items of the Marder negative symptoms factor of the PANSS, which is a 30-item clinician-rated instrument used to assess schizophrenia symptoms. Marder factors are a modified grouping of the 30 PANSS items. For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. PANSS Marder factor negative symptom score for each participant was sum of the rating assigned to each of the 7 applicable Marder factor items, and ranged from 7 to 49 with a higher score indicating greater severity of symptoms. Measure reports change from baseline; improvement in symptoms is represented by negative values. | Baseline and Days 4, 7, 14, 21, 28, 35 and 42 |
| Change From Baseline in PANSS Marder Factor Disorganized Thought Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42 | This measure reports results for the 7 items of the Marder disorganized thoughts factor of the PANSS, which is a 30-item clinician-rated instrument used to assess schizophrenia symptoms. Marder factors are a modified grouping of the 30 PANSS items. For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. PANSS Marder factor disorganized thought symptom score for each participant was sum of rating assigned to each of the 7 applicable Marder factor items, and ranged from 7 to 49 with a higher score indicating greater severity of symptoms. Measure reports change from baseline; improvement in symptoms is represented by negative values. | Baseline and Days 4, 7, 14, 21, 28, 35 and 42 |
| Change From Baseline in PANSS Marder Factor Hostility/Excitement Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42 | This measure reports results for the 4 items of the Marder hostility/excitement factor of the PANSS, which is a 30-item clinician-rated instrument used to assess schizophrenia symptoms. Marder factors are a modified grouping of the 30 PANSS items. For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. PANSS Marder factor hostility/excitement symptom score for each participant was sum of rating assigned to each of the 4 applicable Marder factor items, and ranged from 4 to 28 with a higher score indicating greater severity of symptoms. Measure reports change from baseline; improvement in symptoms is represented by negative values. | Baseline and Days 4, 7, 14, 21, 28, 35 and 42 |
| Change From Baseline in PANSS Marder Factor Anxiety/Depression Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42 | This measure reports results for the 4 items of the Marder anxiety/depression factor of the PANSS, which is a 30-item clinician-rated instrument used to assess schizophrenia symptoms. Marder factors are a modified grouping of the 30 PANSS items. For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. PANSS Marder factor anxiety/depression symptom score for each participant was sum of rating assigned to each of the 4 applicable Marder factor items, and ranged from 4 to 28 with a higher score indicating greater severity of symptoms. Measure reports change from baseline; improvement in symptoms is represented by negative values. | Baseline and Days 4, 7, 14, 21, 28, 35 and 42 |
| Not Treated: Adverse Event |
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| Not Treated: Completed study in database |
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| COMPLETED |
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| NOT COMPLETED |
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| BG002 | Olanzapine 15 mg QD | Participants were administered 15 mg olanzapine (as one 10 mg and one 5 mg tablet) QD for 42 days, except during Week 1 olanzapine 10 mg QD was administered |
| BG003 | Placebo BID | Participants were administered placebo tablets BID for 42 days |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Positive and Negative Syndrome Scale (PANSS) total score | The PANSS is a 30-item scale for assessing the symptoms of schizophrenia. For each PANSS item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The PANSS total score (30 items) ranged from 30 to 210 with a higher score indicating greater severity of symptoms. Summary statistics presented are for efficacy population (Full Analysis Set [FAS]): N=96, 111, 45, 99 and 351 for asenapine 2.5 mg BID, asenapine 5 mg BID, olanzapine 15 mg QD, placebo BID and Total groups, respectively. | Mean | Standard Deviation | score on a scale |
|
| Clinical Global Impression Scale-Severity (CGI-S) score | CGI-S is a 7-point scale for assessing the global severity of the participant's illness, with ratings from 1=normal, not ill to 7=very severely ill. Summary statistics presented are for efficacy population (FAS): N=96, 111, 45, 99 and 351 for asenapine 2.5 mg BID, asenapine 5 mg BID, olanzapine 15 mg QD, placebo BID and Total groups, respectively. | Mean | Standard Deviation | score on a scale |
|
| Body Weight | Mean | Standard Deviation | kg |
|
| PANSS negative subscale score | The PANSS is a 30-item scale for assessing the symptoms of schizophrenia. For each PANSS item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The PANSS negative subscale score (7 PANSS items) ranged from 7 to 49 with a higher score indicating greater severity of symptoms. Summary statistics presented are for efficacy population (FAS): N=96, 111, 45, 99 and 351 for asenapine 2.5 mg BID, asenapine 5 mg BID, olanzapine 15 mg QD, placebo BID and Total groups, respectively. | Mean | Standard Deviation | score on a scale |
|
| PANSS positive subscale score | The PANSS is a 30-item scale for assessing the symptoms of schizophrenia. For each PANSS item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The PANSS positive subscale score (7 PANSS items) ranged from 7 to 49 with a higher score indicating greater severity of symptoms. Summary statistics presented are for efficacy population (FAS): N=96, 111, 45, 99 and 351 for asenapine 2.5 mg BID, asenapine 5 mg BID, olanzapine 15 mg QD, placebo BID and Total groups, respectively. | Mean | Standard Deviation | score on a scale |
|
| PANSS general psychopathology subscale score | The PANSS is a 30-item scale for assessing the symptoms of schizophrenia. For each PANSS item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The PANSS general psychopathology subscale score (16 PANSS items) ranged from 16 to 112 with a higher score indicating greater severity of symptoms. Summary statistics presented are for efficacy population (FAS): N=96, 111, 45, 99 and 351 for asenapine 2.5 mg BID, asenapine 5 mg BID, olanzapine 15 mg QD, placebo BID and Total groups, respectively. | Mean | Standard Deviation | score on a scale |
|
| PANSS Marder factor positive symptom score | The PANSS is a 30-item scale for assessing the symptoms of schizophrenia. For each PANSS item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The PANSS Marder factor positive symptom score (calculated from value of 8 identified PANSS items) ranged from 8 to 56 with a higher score indicating greater severity of symptoms. Summary statistics presented are for efficacy population (FAS): N=96, 111, 45, 99 and 351 for asenapine 2.5 mg BID, asenapine 5 mg BID, olanzapine 15 mg QD, placebo BID and Total groups, respectively. | Mean | Standard Deviation | score on a scale |
|
| PANSS Marder factor negative symptom score | The PANSS is a 30-item scale for assessing the symptoms of schizophrenia. For each PANSS item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The PANSS Marder factor negative symptom score (calculated from value of 7 identified PANSS items) ranged from 7 to 49 with a higher score indicating greater severity of symptoms. Summary statistics presented are for efficacy population (FAS): N=96, 111, 45, 99 and 351 for asenapine 2.5 mg BID, asenapine 5 mg BID, olanzapine 15 mg QD, placebo BID and Total groups, respectively. | Mean | Standard Deviation | score on a scale |
|
| PANSS Marder factor disorganized thought symptom score | The PANSS is a 30-item scale for assessing the symptoms of schizophrenia. For each PANSS item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The PANSS Marder factor disorganized thought symptom score (calculated from value of 7 identified PANSS items) ranged from 7 to 49 with a higher score indicating greater severity of symptoms. Summary statistics presented are for efficacy population (FAS): N=96, 111, 45, 99 and 351 for asenapine 2.5 mg BID, asenapine 5 mg BID, olanzapine 15 mg QD, placebo BID and Total groups, respectively. | Mean | Standard Deviation | score on a scale |
|
| PANSS Marder factor hostility/excitement symptom score | The PANSS is a 30-item scale for assessing the symptoms of schizophrenia. For each PANSS item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The PANSS Marder factor hostility/excitement symptom score (calculated from value of 4 identified PANSS items) ranged from 4 to 28 with a higher score indicating greater severity of symptoms. Summary statistics presented are for efficacy population (FAS): N=96, 111, 45, 99 and 351 for asenapine 2.5 mg BID, asenapine 5 mg BID, olanzapine 15 mg QD, placebo BID and Total groups, respectively. | Mean | Standard Deviation | score on a scale |
|
| PANSS Marder factor anxiety/depression symptom score | The PANSS is a 30-item scale for assessing the symptoms of schizophrenia. For each PANSS item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The PANSS Marder factor anxiety/depression symptom score (calculated from value of 4 identified PANSS items) ranged from 4 to 28 with a higher score indicating greater severity of symptoms. Summary statistics presented are for efficacy population (FAS): N=96, 111, 45, 99 and 351 for asenapine 2.5 mg BID, asenapine 5 mg BID, olanzapine 15 mg QD, placebo BID and Total groups, respectively. | Mean | Standard Deviation | score on a scale |
|
Participants were administered one 2.5 mg asenapine tablet BID for 42 days
| OG001 | Asenapine 5 mg BID | Participants were administered one 5 mg asenapine tablet BID for 42 days |
| OG002 | Olanzapine 15 mg QD | Participants were administered 15 mg olanzapine (as one 10 mg and one 5 mg tablet) QD for 42 days, except during Week 1 olanzapine 10 mg QD was administered |
| OG003 | Placebo BID | Participants were administered placebo tablets BID for 42 days |
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| Secondary | Change From Baseline in CGI-S Score at Day 42 | Change from baseline in CGI-S score at Day 42 is a Key Secondary Outcome Measure. CGI-S is a 7-point scale for assessing the global severity of the participant's illness, with ratings from 1=normal, not ill to 7=very severely ill. The reported measure is the change from baseline at Day 42; improvement in symptoms is represented by negative values. | FAS, defined as randomized participants who received ≥1 dose of study drug and had both a baseline and ≥1 post-baseline PANSS Total Score | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline and Day 42 |
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| Secondary | Percentage of Participants Who Are PANSS Responders (≥30% Reduction From Baseline in PANSS Total Score) at Day 42 | Rate of PANSS responders at Day 42 is a Key Secondary Outcome Measure. A PANSS responder was defined as a participant who had a reduction from baseline of at least 30% in the PANSS total score at a post-baseline assessment. The PANSS is a 30-item clinician-rated instrument for assessing schizophrenia symptoms. For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The Total score is the sum of the ratings for the individual items, and ranged from 30 to 210 with a higher score indicating greater severity of symptoms. Missing data were imputed by Last Observation Carried Forward (LOCF). | FAS, defined as randomized participants who received ≥1 dose of study drug and had both a baseline and ≥1 post-baseline PANSS Total Score | Posted | Number | percentage of participants | Baseline and Day 42 |
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| Secondary | Change From Baseline in Body Weight at Day 42 | Change from baseline in body weight at Day 42 is the Key Safety Outcome Measure. | All randomized participants who received ≥1 dose of study drug | Posted | Least Squares Mean | Standard Error | kg | Baseline and Day 42 |
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| Secondary | Change From Baseline in PANSS Total Score at Days 4, 7, 14, 21, 28 and 35 | The PANSS is a 30-item clinician-rated instrument for assessing schizophrenia symptoms. It consists of 3 subscales: positive subscale (7 items), negative subscale (7 items), and general psychopathology subscale (16 items). For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The PANSS total score for each participant was sum of the rating assigned to each of the 30 PANSS items, and ranged from 30 to 210 with a higher score indicating greater severity of symptoms. The reported measure is the change from baseline; improvement in symptoms is represented by negative values. | FAS, defined as randomized participants who received ≥1 dose of study drug and had both a baseline and ≥1 post-baseline PANSS Total Score | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline and Days 4, 7, 14, 21, 28 and 35 |
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| Secondary | Percentage of Participants Who Are PANSS Responders (≥30% Reduction From Baseline in PANSS Total Score) at Days 4, 7, 14, 21, 28 and 35 | A PANSS responder was defined as a participant who had a reduction from baseline of at least 30% in the PANSS total score at a post-baseline assessment. The PANSS is a 30-item clinician-rated instrument for assessing schizophrenia symptoms. For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The Total score is the sum of the ratings for the individual items, and ranged from 30 to 210 with a higher score indicating greater severity of symptoms. Missing data were imputed by LOCF. | FAS, defined as randomized participants who received ≥1 dose of study drug and had both a baseline and ≥1 post-baseline PANSS Total Score | Posted | Number | percentage of participants | Days 4, 7, 14, 21, 28 and 35 |
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| Secondary | Change From Baseline in CGI-S Score at Days 4, 7, 14, 21, 28 and 35 | CGI-S is a 7-point scale for assessing the global severity of the participant's illness, with ratings from 1=normal, not ill to 7=very severely ill. The reported measure is the change from baseline; improvement in symptoms is represented by negative values. | FAS, defined as randomized participants who received ≥1 dose of study drug and had both a baseline and ≥1 post-baseline PANSS Total Score | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline and Days 4, 7, 14, 21, 28 and 35 |
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| Secondary | Percentage of Participants Who Are Clinical Global Impression Scale-Improvement (CGI-I) Responders at Days 4, 7, 14, 21, 28, 35 and 42 | A CGI-I responder was defined as a participant who had a CGI-I score of 1 (very much improved) or 2 (much improved) at a post-baseline assessment. CGI-I is a 7-point scale for assessing the global improvement of the participant's illness relative to baseline, with ratings from 1=very much improved to 7=very much worse. Missing data were imputed by LOCF. | FAS, defined as randomized participants who received ≥1 dose of study drug and had both a baseline and ≥1 post-baseline PANSS Total Score | Posted | Number | percentage of participants | Days 4, 7, 14, 21, 28, 35 and 42 |
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| Secondary | Change From Baseline in PANSS Negative Subscale Score at Days 4, 7, 14, 21, 28, 35 and 42 | This measure reports results for the 7 items of the negative subscale of the PANSS, which is a 30-item clinician-rated instrument used to assess schizophrenia symptoms. Negative symptoms represent a diminution or loss of normal functions (e.g., emotional withdrawal). For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. PANSS negative subscale score for each participant was sum of the rating assigned to each of the 7 subscale items, and ranged from 7 to 49 with a higher score indicating greater severity of symptoms. Measure reports change from baseline; improvement in symptoms is represented by negative values. | FAS, defined as randomized participants who received ≥1 dose of study drug and had both a baseline and ≥1 post-baseline PANSS Total Score | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline and Days 4, 7, 14, 21, 28, 35 and 42 |
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| Secondary | Change From Baseline in PANSS Positive Subscale Score at Days 4, 7, 14, 21, 28, 35 and 42 | This measure reports results for the 7 items of the positive subscale of the PANSS, which is a 30-item clinician-rated instrument used to assess schizophrenia symptoms. Positive symptoms refer to an excess or distortion of normal mental status (e.g., delusions). For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. PANSS positive subscale score for each participant was sum of the rating assigned to each of the 7 subscale items, and ranged from 7 to 49 with a higher score indicating greater severity of symptoms. Measure reports change from baseline; improvement in symptoms is represented by negative values. | FAS, defined as randomized participants who received ≥1 dose of study drug and had both a baseline and ≥1 post-baseline PANSS Total Score | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline and Days 4, 7, 14, 21, 28, 35 and 42 |
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|
| Secondary | Change From Baseline in PANSS General Psychopathology Subscale Score at Days 4, 7, 14, 21, 28, 35 and 42 | This measure reports results for the 16 items of the general psychopathology subscale of the PANSS, which is a 30-item clinician-rated instrument used to assess the symptoms of schizophrenia. For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The PANSS general psychopathology subscale score for each participant was calculated as the sum of the rating assigned to each of the 16 subscale items, and ranged from 16 to 112 with a higher score indicating greater severity of symptoms. The reported measure is the change from baseline; improvement in symptoms is represented by negative values. | FAS, defined as randomized participants who received ≥1 dose of study drug and had both a baseline and ≥1 post-baseline PANSS Total Score | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline and Days 4, 7, 14, 21, 28, 35 and 42 |
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|
|
| Secondary | Change From Baseline in PANSS Marder Factor Positive Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42 | This measure reports results for the 8 items of the Marder positive symptom factor of the PANSS, which is a 30-item clinician-rated instrument used to assess schizophrenia symptoms. Marder factors are a modified grouping of the 30 PANSS items. For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. PANSS Marder factor positive symptom score for each participant was sum of rating assigned to each of the 8 applicable Marder factor items, and ranged from 8 to 56 with a higher score indicating greater severity of symptoms. Measure reports change from baseline; improvement in symptoms is represented by negative values. | FAS, defined as randomized participants who received ≥1 dose of study drug and had both a baseline and ≥1 post-baseline PANSS Total Score | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline and Days 4, 7, 14, 21, 28, 35 and 42 |
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|
|
|
| Secondary | Change From Baseline in PANSS Marder Factor Negative Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42 | This measure reports results for the 7 items of the Marder negative symptoms factor of the PANSS, which is a 30-item clinician-rated instrument used to assess schizophrenia symptoms. Marder factors are a modified grouping of the 30 PANSS items. For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. PANSS Marder factor negative symptom score for each participant was sum of the rating assigned to each of the 7 applicable Marder factor items, and ranged from 7 to 49 with a higher score indicating greater severity of symptoms. Measure reports change from baseline; improvement in symptoms is represented by negative values. | FAS, defined as randomized participants who received ≥1 dose of study drug and had both a baseline and ≥1 post-baseline PANSS Total Score | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline and Days 4, 7, 14, 21, 28, 35 and 42 |
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|
|
| Secondary | Change From Baseline in PANSS Marder Factor Disorganized Thought Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42 | This measure reports results for the 7 items of the Marder disorganized thoughts factor of the PANSS, which is a 30-item clinician-rated instrument used to assess schizophrenia symptoms. Marder factors are a modified grouping of the 30 PANSS items. For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. PANSS Marder factor disorganized thought symptom score for each participant was sum of rating assigned to each of the 7 applicable Marder factor items, and ranged from 7 to 49 with a higher score indicating greater severity of symptoms. Measure reports change from baseline; improvement in symptoms is represented by negative values. | FAS, defined as randomized participants who received ≥1 dose of study drug and had both a baseline and ≥1 post-baseline PANSS Total Score | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline and Days 4, 7, 14, 21, 28, 35 and 42 |
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| Secondary | Change From Baseline in PANSS Marder Factor Hostility/Excitement Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42 | This measure reports results for the 4 items of the Marder hostility/excitement factor of the PANSS, which is a 30-item clinician-rated instrument used to assess schizophrenia symptoms. Marder factors are a modified grouping of the 30 PANSS items. For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. PANSS Marder factor hostility/excitement symptom score for each participant was sum of rating assigned to each of the 4 applicable Marder factor items, and ranged from 4 to 28 with a higher score indicating greater severity of symptoms. Measure reports change from baseline; improvement in symptoms is represented by negative values. | FAS, defined as randomized participants who received ≥1 dose of study drug and had both a baseline and ≥1 post-baseline PANSS Total Score | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline and Days 4, 7, 14, 21, 28, 35 and 42 |
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| Secondary | Change From Baseline in PANSS Marder Factor Anxiety/Depression Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42 | This measure reports results for the 4 items of the Marder anxiety/depression factor of the PANSS, which is a 30-item clinician-rated instrument used to assess schizophrenia symptoms. Marder factors are a modified grouping of the 30 PANSS items. For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. PANSS Marder factor anxiety/depression symptom score for each participant was sum of rating assigned to each of the 4 applicable Marder factor items, and ranged from 4 to 28 with a higher score indicating greater severity of symptoms. Measure reports change from baseline; improvement in symptoms is represented by negative values. | FAS, defined as randomized participants who received ≥1 dose of study drug and had both a baseline and ≥1 post-baseline PANSS Total Score | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline and Days 4, 7, 14, 21, 28, 35 and 42 |
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|
|
|
| 5 |
| 97 |
| 27 |
| 97 |
| EG001 | Asenapine 5 mg BID | Participants were administered one 5 mg asenapine tablet BID for 42 days | 5 | 113 | 47 | 113 |
| EG002 | Olanzapine 15 mg QD | Participants were administered 15 mg olanzapine (as one 10 mg and one 5 mg tablet) QD for 42 days, except during Week 1 olanzapine 10 mg QD was administered | 1 | 46 | 17 | 46 |
| EG003 | Placebo BID | Participants were administered placebo tablets BID for 42 days | 8 | 101 | 29 | 101 |
| Chest pain | General disorders | MedDRA 17.0 | Systematic Assessment |
|
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
|
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 17.0 | Systematic Assessment |
|
| Epilepsy | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
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| Syncope | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
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| Agitation | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
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| Homicidal ideation | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
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| Psychotic disorder | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
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| Schizophrenia | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
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| Schizophrenia, paranoid type | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
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| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
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| Hypoaesthesia oral | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
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| Blood creatine phosphokinase increased | Investigations | MedDRA 17.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
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| Agitation | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
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| Schizophrenia | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
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It is planned to first publish/present trial results together with the other sites, unless permission is obtained from Sponsor to publish separate results. Sponsor must be able to review all proposed results communications regarding study 45 days prior to submission for publication/presentation. If there is disagreement concerning appropriateness of the materials, Investigator and Sponsor must meet to make a good faith effort to discuss/resolve disagreement prior to submission for publication.
| D006571 | Heterocyclic Compounds |
| Confirmative testing of asenapine versus placebo for this measure was to be performed only if both asenapine doses were statistically superior to placebo in reduction from baseline in PANSS Total Score (Primary outcome measure) | MMRM | 0.0601 | Unadjusted p-value | LS means difference | -0.3 | Standard Error of the Mean | 0.14 | 2-Sided | 95 | -0.6 | 0.0 | Asenapine 5 mg BID minus Placebo BID | Superiority or Other (legacy) |
| MMRM | 0.3898 | Unadjusted p-value | LS means difference | -0.2 | Standard Error of the Mean | 0.18 | 2-Sided | 95 | -0.5 | 0.2 | Olanzapine 15 mg BID minus Placebo BID | Superiority or Other (legacy) |
Confirmative testing of asenapine versus placebo for this measure was to be performed only if both asenapine doses were statistically superior to placebo in reduction from baseline in PANSS Total Score (Primary outcome measure) |
| Cochran-Mantel-Haenszel |
| 0.1708 |
P-value from Cochran Mantel-Haenszel test with an adjustment for pooled center |
| Superiority or Other (legacy) |
| Cochran-Mantel-Haenszel | 0.2620 | P-value from Cochran Mantel-Haenszel test with an adjustment for pooled center | Superiority or Other (legacy) |
| MMRM |
| 0.0491 |
p-value adjusted for multiple comparisons using Hochberg's method |
| LS means difference |
| -1.2 |
| Standard Error of the Mean |
| 0.57 |
| 2-Sided |
| 95 |
| -2.3 |
| -0.0 |
Asenapine 5 mg BID minus Olanzapine 15 mg QD |
| Superiority or Other (legacy) |
| MMRM | 0.0567 | Unadjusted p-value | LS means difference | 1.0 | Standard Error of the Mean | 0.51 | 2-Sided | 95 | -0.0 | 2.0 | Asenapine 2.5 mg BID minus Placebo BID | Superiority or Other (legacy) |
| MMRM | 0.0391 | Unadjusted p-value | LS means difference | 1.0 | Standard Error of the Mean | 0.48 | 2-Sided | 95 | 0.0 | 1.9 | Asenapine 5 mg BID minus Placebo BID | Superiority or Other (legacy) |
| MMRM | 0.0003 | Unadjusted p-value | LS means difference | 2.2 | Standard Error of the Mean | 0.58 | 2-Sided | 95 | 1.0 | 3.3 | Olanzapine 15 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 7 |
|
| Day 14 |
|
| Day 21 |
|
| Day 28 |
|
| Day 35 |
|
Day 4 |
| MMRM |
| 0.8902 |
Unadjusted p-value |
| LS means difference |
| -0.1 |
| Standard Error of the Mean |
| 1.06 |
| 2-Sided |
| 95 |
| -2.2 |
| 1.9 |
Asenapine 5 mg BID minus Placebo BID |
| Superiority or Other (legacy) |
| Day 4 | MMRM | 0.5826 | Unadjusted p-value | LS means difference | -0.8 | Standard Error of the Mean | 1.36 | 2-Sided | 95 | -3.4 | 1.9 | Olanzapine 15 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 7 | MMRM | 0.9271 | Unadjusted p-value | LS means difference | -0.1 | Standard Error of the Mean | 1.61 | 2-Sided | 95 | -3.3 | 3.0 | Asenapine 2.5 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 7 | MMRM | 0.1902 | Unadjusted p-value | LS means difference | -2.0 | Standard Error of the Mean | 1.56 | 2-Sided | 95 | -5.1 | 1.0 | Asenapine 5 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 7 | MMRM | 0.2710 | Unadjusted p-value | LS means difference | -2.2 | Standard Error of the Mean | 2.00 | 2-Sided | 95 | -6.2 | 1.7 | Olanzapine 15 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 14 | MMRM | 0.6773 | Unadjusted p-value | LS means difference | 0.7 | Standard Error of the Mean | 1.79 | 2-Sided | 95 | -2.8 | 4.3 | Asenapine 2.5 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 14 | MMRM | 0.2895 | Unadjusted p-value | LS means difference | -1.8 | Standard Error of the Mean | 1.72 | 2-Sided | 95 | -5.2 | 1.6 | Asenapine 5 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 14 | MMRM | 0.4261 | Unadjusted p-value | LS means difference | -1.7 | Standard Error of the Mean | 2.18 | 2-Sided | 95 | -6.0 | 2.6 | Olanzapine 15 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 21 | MMRM | 0.5505 | Unadjusted p-value | LS means difference | 1.3 | Standard Error of the Mean | 2.13 | 2-Sided | 95 | -2.9 | 5.5 | Asenapine 2.5 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 21 | MMRM | 0.4286 | Unadjusted p-value | LS means difference | -1.6 | Standard Error of the Mean | 2.03 | 2-Sided | 95 | -5.6 | 2.4 | Asenapine 5 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 21 | MMRM | 0.4423 | Unadjusted p-value | LS means difference | -2.0 | Standard Error of the Mean | 2.56 | 2-Sided | 95 | -7.0 | 3.1 | Olanzapine 15 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 28 | MMRM | 0.1691 | Unadjusted p-value | LS means difference | 3.2 | Standard Error of the Mean | 2.30 | 2-Sided | 95 | -1.4 | 7.7 | Asenapine 2.5 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 28 | MMRM | 0.4682 | Unadjusted p-value | LS means difference | -1.6 | Standard Error of the Mean | 2.17 | 2-Sided | 95 | -5.8 | 2.7 | Asenapine 5 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 28 | MMRM | 0.4961 | Unadjusted p-value | LS means difference | -1.8 | Standard Error of the Mean | 2.71 | 2-Sided | 95 | -7.2 | 3.5 | Olanzapine 15 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 35 | MMRM | 0.4697 | Unadjusted p-value | LS means difference | -1.6 | Standard Error of the Mean | 2.26 | 2-Sided | 95 | -6.1 | 2.8 | Asenapine 2.5 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 35 | MMRM | 0.0947 | Unadjusted p-value | LS means difference | -3.6 | Standard Error of the Mean | 2.14 | 2-Sided | 95 | -7.8 | 0.6 | Asenapine 5 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 35 | MMRM | 0.0675 | Unadjusted p-value | LS means difference | -4.9 | Standard Error of the Mean | 2.68 | 2-Sided | 95 | -10.2 | 0.4 | Olanzapine 15 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 7 (n = 96,111,45,99) |
|
| Day 14 (n = 96,111,45,99) |
|
| Day 21 (n = 96,111,45,99) |
|
| Day 28 (n = 96,111,45,99) |
|
| Day 35 (n = 96,111,45,99) |
|
| Cochran-Mantel-Haenszel |
| 0.1736 |
P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center |
| Superiority or Other (legacy) |
| Day 4 | Cochran-Mantel-Haenszel | 0.2850 | P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center | Superiority or Other (legacy) |
| Day 7 | Cochran-Mantel-Haenszel | 0.3290 | P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center | Superiority or Other (legacy) |
| Day 7 | Cochran-Mantel-Haenszel | 0.6938 | P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center | Superiority or Other (legacy) |
| Day 7 | Cochran-Mantel-Haenszel | 0.1105 | P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center | Superiority or Other (legacy) |
| Day 14 | Cochran-Mantel-Haenszel | 0.6804 | P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center | Superiority or Other (legacy) |
| Day 14 | Cochran-Mantel-Haenszel | 0.9704 | P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center | Superiority or Other (legacy) |
| Day 14 | Cochran-Mantel-Haenszel | 0.6604 | P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center | Superiority or Other (legacy) |
| Day 21 | Cochran-Mantel-Haenszel | 0.2447 | P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center | Superiority or Other (legacy) |
| Day 21 | Cochran-Mantel-Haenszel | 0.4834 | P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center | Superiority or Other (legacy) |
| Day 21 | Cochran-Mantel-Haenszel | 0.9189 | P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center | Superiority or Other (legacy) |
| Day 28 | Cochran-Mantel-Haenszel | 0.4370 | P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center | Superiority or Other (legacy) |
| Day 28 | Cochran-Mantel-Haenszel | 0.2894 | P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center | Superiority or Other (legacy) |
| Day 28 | Cochran-Mantel-Haenszel | 0.6953 | P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center | Superiority or Other (legacy) |
| Day 35 | Cochran-Mantel-Haenszel | 0.4892 | P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center | Superiority or Other (legacy) |
| Day 35 | Cochran-Mantel-Haenszel | 0.1954 | P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center | Superiority or Other (legacy) |
| Day 35 | Cochran-Mantel-Haenszel | 0.7990 | P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center | Superiority or Other (legacy) |
| Day 7 |
|
| Day 14 |
|
| Day 21 |
|
| Day 28 |
|
| Day 35 |
|
Day 4 |
| MMRM |
| 0.9564 |
Unadjusted p-value |
| LS means difference |
| -0.0 |
| Standard Error of the Mean |
| 0.06 |
| 2-Sided |
| 95 |
| -0.1 |
| 0.1 |
Asenapine 5 mg BID minus Placebo BID |
| Superiority or Other (legacy) |
| Day 4 | MMRM | 0.6363 | Unadjusted p-value | LS means difference | -0.0 | Standard Error of the Mean | 0.08 | 2-Sided | 95 | -0.2 | 0.1 | Olanzapine 15 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 7 | MMRM | 0.8759 | Unadjusted p-value | LS means difference | -0.0 | Standard Error of the Mean | 0.10 | 2-Sided | 95 | -0.2 | 0.2 | Asenapine 2.5 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 7 | MMRM | 0.9598 | Unadjusted p-value | LS means difference | 0.0 | Standard Error of the Mean | 0.09 | 2-Sided | 95 | -0.2 | 0.2 | Asenapine 5 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 7 | MMRM | 0.9789 | Unadjusted p-value | LS means difference | -0.0 | Standard Error of the Mean | 0.12 | 2-Sided | 95 | -0.2 | 0.2 | Olanzapine 15 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 14 | MMRM | 0.4671 | Unadjusted p-value | LS means difference | -0.1 | Standard Error of the Mean | 0.11 | 2-Sided | 95 | -0.3 | 0.1 | Asenapine 2.5 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 14 | MMRM | 0.6359 | Unadjusted p-value | LS means difference | -0.1 | Standard Error of the Mean | 0.11 | 2-Sided | 95 | -0.3 | 0.2 | Asenapine 5 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 14 | MMRM | 0.5454 | Unadjusted p-value | LS means difference | -0.1 | Standard Error of the Mean | 0.14 | 2-Sided | 95 | -0.4 | 0.2 | Olanzapine 15 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 21 | MMRM | 0.4188 | Unadjusted p-value | LS means difference | 0.1 | Standard Error of the Mean | 0.13 | 2-Sided | 95 | -0.2 | 0.4 | Asenapine 2.5 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 21 | MMRM | 0.5318 | Unadjusted p-value | LS means difference | -0.1 | Standard Error of the Mean | 0.13 | 2-Sided | 95 | -0.3 | 0.2 | Asenapine 5 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 21 | MMRM | 0.5683 | Unadjusted p-value | LS means difference | -0.1 | Standard Error of the Mean | 0.16 | 2-Sided | 95 | -0.4 | 0.2 | Olanzapine 15 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 28 | MMRM | 0.2972 | Unadjusted p-value | LS means difference | 0.2 | Standard Error of the Mean | 0.14 | 2-Sided | 95 | -0.1 | 0.4 | Asenapine 2.5 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 28 | MMRM | 0.4820 | Unadjusted p-value | LS means difference | -0.1 | Standard Error of the Mean | 0.13 | 2-Sided | 95 | -0.4 | 0.2 | Asenapine 5 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 28 | MMRM | 0.9901 | Unadjusted p-value | LS means difference | -0.0 | Standard Error of the Mean | 0.17 | 2-Sided | 95 | -0.3 | 0.3 | Olanzapine 15 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 35 | MMRM | 0.6682 | Unadjusted p-value | LS means difference | -0.1 | Standard Error of the Mean | 0.15 | 2-Sided | 95 | -0.4 | 0.2 | Asenapine 2.5 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 35 | MMRM | 0.1111 | Unadjusted p-value | LS means difference | -0.2 | Standard Error of the Mean | 0.14 | 2-Sided | 95 | -0.5 | 0.1 | Asenapine 5 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 35 | MMRM | 0.2400 | Unadjusted p-value | LS means difference | -0.2 | Standard Error of the Mean | 0.17 | 2-Sided | 95 | -0.5 | 0.1 | Olanzapine 15 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 7 (n = 96,111,45,99) |
|
| Day 14 (n = 96,111,45,99) |
|
| Day 21 (n = 96,111,45,99) |
|
| Day 28 (n = 96,111,45,99) |
|
| Day 35 (n = 96,111,45,99) |
|
| Day 42 (n = 96,111,45,99) |
|
| Cochran-Mantel-Haenszel |
| 0.4829 |
P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center |
| Superiority or Other (legacy) |
| Day 4 | Cochran-Mantel-Haenszel | 0.3945 | P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center | Superiority or Other (legacy) |
| Day 7 | Cochran-Mantel-Haenszel | 0.4076 | P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center | Superiority or Other (legacy) |
| Day 7 | Cochran-Mantel-Haenszel | 0.9690 | P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center | Superiority or Other (legacy) |
| Day 7 | Cochran-Mantel-Haenszel | 0.1170 | P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center | Superiority or Other (legacy) |
| Day 14 | Cochran-Mantel-Haenszel | 0.5088 | P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center | Superiority or Other (legacy) |
| Day 14 | Cochran-Mantel-Haenszel | 0.3426 | P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center | Superiority or Other (legacy) |
| Day 14 | Cochran-Mantel-Haenszel | 0.0762 | P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center | Superiority or Other (legacy) |
| Day 21 | Cochran-Mantel-Haenszel | 0.5531 | P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center | Superiority or Other (legacy) |
| Day 21 | Cochran-Mantel-Haenszel | 0.4875 | P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center | Superiority or Other (legacy) |
| Day 21 | Cochran-Mantel-Haenszel | 0.0692 | P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center | Superiority or Other (legacy) |
| Day 28 | Cochran-Mantel-Haenszel | 0.7482 | P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center | Superiority or Other (legacy) |
| Day 28 | Cochran-Mantel-Haenszel | 0.8037 | P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center | Superiority or Other (legacy) |
| Day 28 | Cochran-Mantel-Haenszel | 0.0859 | P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center | Superiority or Other (legacy) |
| Day 35 | Cochran-Mantel-Haenszel | 0.5850 | P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center | Superiority or Other (legacy) |
| Day 35 | Cochran-Mantel-Haenszel | 0.9698 | P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center | Superiority or Other (legacy) |
| Day 35 | Cochran-Mantel-Haenszel | 0.0132 | P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center | Superiority or Other (legacy) |
| Day 42 | Cochran-Mantel-Haenszel | 0.7129 | P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center | Superiority or Other (legacy) |
| Day 42 | Cochran-Mantel-Haenszel | 0.5074 | P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center | Superiority or Other (legacy) |
| Day 42 | Cochran-Mantel-Haenszel | 0.0040 | P-value from Cochran-Mantel-Haenszel test with an adjustment for pooled center | Superiority or Other (legacy) |
| Day 7 |
|
| Day 14 |
|
| Day 21 |
|
| Day 28 |
|
| Day 35 |
|
| Day 42 |
|
Day 4 |
| MMRM |
| 0.5488 |
Unadjusted p-value |
| LS means difference |
| 0.2 |
| Standard Error of the Mean |
| 0.39 |
| 2-Sided |
| 95 |
| -0.5 |
| 1.0 |
Asenapine 5 mg BID minus Placebo BID |
| Superiority or Other (legacy) |
| Day 4 | MMRM | 0.7830 | Unadjusted p-value | LS means difference | -0.1 | Standard Error of the Mean | 0.50 | 2-Sided | 95 | -1.1 | 0.8 | Olanzapine 15 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 7 | MMRM | 0.8070 | Unadjusted p-value | LS means difference | -0.1 | Standard Error of the Mean | 0.45 | 2-Sided | 95 | -1.0 | 0.8 | Asenapine 2.5 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 7 | MMRM | 0.5280 | Unadjusted p-value | LS means difference | -0.3 | Standard Error of the Mean | 0.44 | 2-Sided | 95 | -1.1 | 0.6 | Asenapine 5 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 7 | MMRM | 0.4025 | Unadjusted p-value | LS means difference | -0.5 | Standard Error of the Mean | 0.57 | 2-Sided | 95 | -1.6 | 0.6 | Olanzapine 15 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 14 | MMRM | 0.6471 | Unadjusted p-value | LS means difference | 0.2 | Standard Error of the Mean | 0.51 | 2-Sided | 95 | -0.8 | 1.2 | Asenapine 2.5 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 14 | MMRM | 0.2504 | Unadjusted p-value | LS means difference | -0.6 | Standard Error of the Mean | 0.49 | 2-Sided | 95 | -1.5 | 0.4 | Asenapine 5 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 14 | MMRM | 0.9223 | Unadjusted p-value | LS means difference | 0.1 | Standard Error of the Mean | 0.62 | 2-Sided | 95 | -1.2 | 1.3 | Olanzapine 15 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 21 | MMRM | 0.8839 | Unadjusted p-value | LS means difference | 0.1 | Standard Error of the Mean | 0.56 | 2-Sided | 95 | -1.0 | 1.2 | Asenapine 2.5 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 21 | MMRM | 0.8077 | Unadjusted p-value | LS means difference | -0.1 | Standard Error of the Mean | 0.54 | 2-Sided | 95 | -1.2 | 0.9 | Asenapine 5 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 21 | MMRM | 0.6216 | Unadjusted p-value | LS means difference | 0.3 | Standard Error of the Mean | 0.68 | 2-Sided | 95 | -1.0 | 1.7 | Olanzapine 15 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 28 | MMRM | 0.4248 | Unadjusted p-value | LS means difference | 0.5 | Standard Error of the Mean | 0.61 | 2-Sided | 95 | -0.7 | 1.7 | Asenapine 2.5 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 28 | MMRM | 0.7667 | Unadjusted p-value | LS means difference | -0.2 | Standard Error of the Mean | 0.58 | 2-Sided | 95 | -1.3 | 1.0 | Asenapine 5 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 28 | MMRM | 0.6282 | Unadjusted p-value | LS means difference | 0.4 | Standard Error of the Mean | 0.72 | 2-Sided | 95 | -1.1 | 1.8 | Olanzapine 15 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 35 | MMRM | 0.3150 | Unadjusted p-value | LS means difference | -0.7 | Standard Error of the Mean | 0.65 | 2-Sided | 95 | -1.9 | 0.6 | Asenapine 2.5 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 35 | MMRM | 0.1908 | Unadjusted p-value | LS means difference | -0.8 | Standard Error of the Mean | 0.61 | 2-Sided | 95 | -2.0 | 0.4 | Asenapine 5 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 35 | MMRM | 0.3128 | Unadjusted p-value | LS means difference | -0.8 | Standard Error of the Mean | 0.77 | 2-Sided | 95 | -2.3 | 0.7 | Olanzapine 15 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 42 | MMRM | 0.8812 | Unadjusted p-value | LS means difference | -0.1 | Standard Error of the Mean | 0.73 | 2-Sided | 95 | -1.5 | 1.3 | Asenapine 2.5 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 42 | MMRM | 0.1143 | Unadjusted p-value | LS means difference | -1.1 | Standard Error of the Mean | 0.69 | 2-Sided | 95 | -2.4 | 0.3 | Asenapine 5 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 42 | MMRM | 0.4418 | Unadjusted p-value | LS means difference | -0.6 | Standard Error of the Mean | 0.84 | 2-Sided | 95 | -2.3 | 1.0 | Olanzapine 15 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 7 |
|
| Day 14 |
|
| Day 21 |
|
| Day 28 |
|
| Day 35 |
|
| Day 42 |
|
Day 4 |
| MMRM |
| 0.9494 |
Unadjusted p-value |
| LS means difference |
| 0.0 |
| Standard Error of the Mean |
| 0.39 |
| 2-Sided |
| 95 |
| -0.7 |
| 0.8 |
Asenapine 5 mg BID minus Placebo BID |
| Superiority or Other (legacy) |
| Day 4 | MMRM | 0.1834 | Unadjusted p-value | LS means difference | -0.7 | Standard Error of the Mean | 0.50 | 2-Sided | 95 | -1.6 | 0.3 | Olanzapine 15 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 7 | MMRM | 0.6347 | Unadjusted p-value | LS means difference | 0.3 | Standard Error of the Mean | 0.53 | 2-Sided | 95 | -0.8 | 1.3 | Asenapine 2.5 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 7 | MMRM | 0.6917 | Unadjusted p-value | LS means difference | -0.2 | Standard Error of the Mean | 0.51 | 2-Sided | 95 | -1.2 | 0.8 | Asenapine 5 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 7 | MMRM | 0.1431 | Unadjusted p-value | LS means difference | -1.0 | Standard Error of the Mean | 0.66 | 2-Sided | 95 | -2.3 | 0.3 | Olanzapine 15 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 14 | MMRM | 0.6267 | Unadjusted p-value | LS means difference | 0.3 | Standard Error of the Mean | 0.61 | 2-Sided | 95 | -0.9 | 1.5 | Asenapine 2.5 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 14 | MMRM | 0.7260 | Unadjusted p-value | LS means difference | -0.2 | Standard Error of the Mean | 0.58 | 2-Sided | 95 | -1.3 | 0.9 | Asenapine 5 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 14 | MMRM | 0.3326 | Unadjusted p-value | LS means difference | -0.7 | Standard Error of the Mean | 0.74 | 2-Sided | 95 | -2.2 | 0.7 | Olanzapine 15 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 21 | MMRM | 0.4575 | Unadjusted p-value | LS means difference | 0.5 | Standard Error of the Mean | 0.72 | 2-Sided | 95 | -0.9 | 1.9 | Asenapine 2.5 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 21 | MMRM | 0.4930 | Unadjusted p-value | LS means difference | -0.5 | Standard Error of the Mean | 0.68 | 2-Sided | 95 | -1.8 | 0.9 | Asenapine 5 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 21 | MMRM | 0.1886 | Unadjusted p-value | LS means difference | -1.1 | Standard Error of the Mean | 0.86 | 2-Sided | 95 | -2.8 | 0.6 | Olanzapine 15 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 28 | MMRM | 0.2643 | Unadjusted p-value | LS means difference | 0.9 | Standard Error of the Mean | 0.80 | 2-Sided | 95 | -0.7 | 2.5 | Asenapine 2.5 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 28 | MMRM | 0.3516 | Unadjusted p-value | LS means difference | -0.7 | Standard Error of the Mean | 0.76 | 2-Sided | 95 | -2.2 | 0.8 | Asenapine 5 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 28 | MMRM | 0.2068 | Unadjusted p-value | LS means difference | -1.2 | Standard Error of the Mean | 0.94 | 2-Sided | 95 | -3.1 | 0.7 | Olanzapine 15 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 35 | MMRM | 0.7284 | Unadjusted p-value | LS means difference | 0.3 | Standard Error of the Mean | 0.82 | 2-Sided | 95 | -1.3 | 1.9 | Asenapine 2.5 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 35 | MMRM | 0.2698 | Unadjusted p-value | LS means difference | -0.9 | Standard Error of the Mean | 0.77 | 2-Sided | 95 | -2.4 | 0.7 | Asenapine 5 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 35 | MMRM | 0.1510 | Unadjusted p-value | LS means difference | -1.4 | Standard Error of the Mean | 0.96 | 2-Sided | 95 | -3.3 | 0.5 | Olanzapine 15 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 42 | MMRM | 0.8039 | Unadjusted p-value | LS means difference | -0.2 | Standard Error of the Mean | 0.88 | 2-Sided | 95 | -2.0 | 1.5 | Asenapine 2.5 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 42 | MMRM | 0.0306 | Unadjusted p-value | LS means difference | -1.8 | Standard Error of the Mean | 0.83 | 2-Sided | 95 | -3.5 | -0.2 | Asenapine 5 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 42 | MMRM | 0.0406 | Unadjusted p-value | LS means difference | -2.1 | Standard Error of the Mean | 1.03 | 2-Sided | 95 | -4.1 | -0.1 | Olanzapine 15 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 7 |
|
| Day 14 |
|
| Day 21 |
|
| Day 28 |
|
| Day 35 |
|
| Day 42 |
|
Day 4 |
| MMRM |
| 0.7030 |
Unadjusted p-value |
| LS means difference |
| -0.2 |
| Standard Error of the Mean |
| 0.65 |
| 2-Sided |
| 95 |
| -1.5 |
| 1.0 |
Asenapine 5 mg BID minus Placebo BID |
| Superiority or Other (legacy) |
| Day 4 | MMRM | 0.9520 | Unadjusted p-value | LS means difference | -0.1 | Standard Error of the Mean | 0.83 | 2-Sided | 95 | -1.7 | 1.6 | Olanzapine 15 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 7 | MMRM | 0.7907 | Unadjusted p-value | LS means difference | -0.3 | Standard Error of the Mean | 0.95 | 2-Sided | 95 | -2.1 | 1.6 | Asenapine 2.5 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 7 | MMRM | 0.1391 | Unadjusted p-value | LS means difference | -1.4 | Standard Error of the Mean | 0.91 | 2-Sided | 95 | -3.1 | 0.4 | Asenapine 5 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 7 | MMRM | 0.4901 | Unadjusted p-value | LS means difference | -0.8 | Standard Error of the Mean | 1.18 | 2-Sided | 95 | -3.1 | 1.5 | Olanzapine 15 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 14 | MMRM | 0.8079 | Unadjusted p-value | LS means difference | 0.2 | Standard Error of the Mean | 1.00 | 2-Sided | 95 | -1.7 | 2.2 | Asenapine 2.5 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 14 | MMRM | 0.3889 | Unadjusted p-value | LS means difference | -0.8 | Standard Error of the Mean | 0.95 | 2-Sided | 95 | -2.7 | 1.1 | Asenapine 5 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 14 | MMRM | 0.3907 | Unadjusted p-value | LS means difference | -1.0 | Standard Error of the Mean | 1.21 | 2-Sided | 95 | -3.4 | 1.3 | Olanzapine 15 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 21 | MMRM | 0.5363 | Unadjusted p-value | LS means difference | 0.7 | Standard Error of the Mean | 1.15 | 2-Sided | 95 | -1.5 | 3.0 | Asenapine 2.5 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 21 | MMRM | 0.5075 | Unadjusted p-value | LS means difference | -0.7 | Standard Error of the Mean | 1.09 | 2-Sided | 95 | -2.9 | 1.4 | Asenapine 5 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 21 | MMRM | 0.4526 | Unadjusted p-value | LS means difference | -1.0 | Standard Error of the Mean | 1.38 | 2-Sided | 95 | -3.7 | 1.7 | Olanzapine 15 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 28 | MMRM | 0.1548 | Unadjusted p-value | LS means difference | 1.8 | Standard Error of the Mean | 1.26 | 2-Sided | 95 | -0.7 | 4.3 | Asenapine 2.5 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 28 | MMRM | 0.6589 | Unadjusted p-value | LS means difference | -0.5 | Standard Error of the Mean | 1.19 | 2-Sided | 95 | -2.9 | 1.8 | Asenapine 5 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 28 | MMRM | 0.5171 | Unadjusted p-value | LS means difference | -1.0 | Standard Error of the Mean | 1.48 | 2-Sided | 95 | -3.9 | 2.0 | Olanzapine 15 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 35 | MMRM | 0.3133 | Unadjusted p-value | LS means difference | -1.2 | Standard Error of the Mean | 1.20 | 2-Sided | 95 | -3.6 | 1.2 | Asenapine 2.5 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 35 | MMRM | 0.1723 | Unadjusted p-value | LS means difference | -1.6 | Standard Error of the Mean | 1.13 | 2-Sided | 95 | -3.8 | 0.7 | Asenapine 5 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 35 | MMRM | 0.0663 | Unadjusted p-value | LS means difference | -2.6 | Standard Error of the Mean | 1.42 | 2-Sided | 95 | -5.4 | 0.2 | Olanzapine 15 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 42 | MMRM | 0.5128 | Unadjusted p-value | LS means difference | -0.9 | Standard Error of the Mean | 1.32 | 2-Sided | 95 | -3.5 | 1.7 | Asenapine 2.5 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 42 | MMRM | 0.0842 | Unadjusted p-value | LS means difference | -2.2 | Standard Error of the Mean | 1.24 | 2-Sided | 95 | -4.6 | 0.3 | Asenapine 5 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 42 | MMRM | 0.1217 | Unadjusted p-value | LS means difference | -2.4 | Standard Error of the Mean | 1.52 | 2-Sided | 95 | -5.4 | 0.6 | Olanzapine 15 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 7 |
|
| Day 14 |
|
| Day 21 |
|
| Day 28 |
|
| Day 35 |
|
| Day 42 |
|
Day 4 |
| MMRM |
| 0.5197 |
Unadjusted p-value |
| LS means difference |
| 0.2 |
| Standard Error of the Mean |
| 0.38 |
| 2-Sided |
| 95 |
| -0.5 |
| 1.0 |
Asenapine 5 mg BID minus Placebo BID |
| Superiority or Other (legacy) |
| Day 4 | MMRM | 0.9693 | Unadjusted p-value | LS means difference | 0.0 | Standard Error of the Mean | 0.49 | 2-Sided | 95 | -0.9 | 1.0 | Olanzapine 15 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 7 | MMRM | 0.6161 | Unadjusted p-value | LS means difference | 0.3 | Standard Error of the Mean | 0.56 | 2-Sided | 95 | -0.8 | 1.4 | Asenapine 2.5 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 7 | MMRM | 0.7880 | Unadjusted p-value | LS means difference | -0.1 | Standard Error of the Mean | 0.54 | 2-Sided | 95 | -1.2 | 0.9 | Asenapine 5 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 7 | MMRM | 0.5526 | Unadjusted p-value | LS means difference | -0.4 | Standard Error of the Mean | 0.70 | 2-Sided | 95 | -1.8 | 1.0 | Olanzapine 15 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 14 | MMRM | 0.7647 | Unadjusted p-value | LS means difference | 0.2 | Standard Error of the Mean | 0.67 | 2-Sided | 95 | -1.1 | 1.5 | Asenapine 2.5 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 14 | MMRM | 0.8900 | Unadjusted p-value | LS means difference | 0.1 | Standard Error of the Mean | 0.64 | 2-Sided | 95 | -1.2 | 1.3 | Asenapine 5 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 14 | MMRM | 0.7097 | Unadjusted p-value | LS means difference | -0.3 | Standard Error of the Mean | 0.81 | 2-Sided | 95 | -1.9 | 1.3 | Olanzapine 15 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 21 | MMRM | 0.4601 | Unadjusted p-value | LS means difference | 0.6 | Standard Error of the Mean | 0.76 | 2-Sided | 95 | -0.9 | 2.1 | Asenapine 2.5 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 21 | MMRM | 0.6288 | Unadjusted p-value | LS means difference | -0.3 | Standard Error of the Mean | 0.72 | 2-Sided | 95 | -1.8 | 1.1 | Asenapine 5 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 21 | MMRM | 0.6099 | Unadjusted p-value | LS means difference | -0.5 | Standard Error of the Mean | 0.91 | 2-Sided | 95 | -2.3 | 1.3 | Olanzapine 15 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 28 | MMRM | 0.2790 | Unadjusted p-value | LS means difference | 0.9 | Standard Error of the Mean | 0.82 | 2-Sided | 95 | -0.7 | 2.5 | Asenapine 2.5 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 28 | MMRM | 0.4253 | Unadjusted p-value | LS means difference | -0.6 | Standard Error of the Mean | 0.77 | 2-Sided | 95 | -2.1 | 0.9 | Asenapine 5 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 28 | MMRM | 0.3014 | Unadjusted p-value | LS means difference | -1.0 | Standard Error of the Mean | 0.96 | 2-Sided | 95 | -2.9 | 0.9 | Olanzapine 15 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 35 | MMRM | 0.9720 | Unadjusted p-value | LS means difference | -0.0 | Standard Error of the Mean | 0.87 | 2-Sided | 95 | -1.7 | 1.7 | Asenapine 2.5 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 35 | MMRM | 0.4758 | Unadjusted p-value | LS means difference | -0.6 | Standard Error of the Mean | 0.82 | 2-Sided | 95 | -2.2 | 1.0 | Asenapine 5 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 35 | MMRM | 0.4419 | Unadjusted p-value | LS means difference | -0.8 | Standard Error of the Mean | 1.03 | 2-Sided | 95 | -2.8 | 1.2 | Olanzapine 15 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 42 | MMRM | 0.4762 | Unadjusted p-value | LS means difference | -0.6 | Standard Error of the Mean | 0.91 | 2-Sided | 95 | -2.4 | 1.1 | Asenapine 2.5 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 42 | MMRM | 0.1046 | Unadjusted p-value | LS means difference | -1.4 | Standard Error of the Mean | 0.86 | 2-Sided | 95 | -3.1 | 0.3 | Asenapine 5 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 42 | MMRM | 0.1411 | Unadjusted p-value | LS means difference | -1.6 | Standard Error of the Mean | 1.06 | 2-Sided | 95 | -3.7 | 0.5 | Olanzapine 15 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 7 |
|
| Day 14 |
|
| Day 21 |
|
| Day 28 |
|
| Day 35 |
|
| Day 42 |
|
Day 4 |
| MMRM |
| 0.8500 |
Unadjusted p-value |
| LS means difference |
| -0.1 |
| Standard Error of the Mean |
| 0.39 |
| 2-Sided |
| 95 |
| -0.8 |
| 0.7 |
Asenapine 5 mg BID minus Placebo BID |
| Superiority or Other (legacy) |
| Day 4 | MMRM | 0.8439 | Unadjusted p-value | LS means difference | -0.1 | Standard Error of the Mean | 0.51 | 2-Sided | 95 | -1.1 | 0.9 | Olanzapine 15 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 7 | MMRM | 0.4741 | Unadjusted p-value | LS means difference | -0.4 | Standard Error of the Mean | 0.51 | 2-Sided | 95 | -1.4 | 0.6 | Asenapine 2.5 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 7 | MMRM | 0.2158 | Unadjusted p-value | LS means difference | -0.6 | Standard Error of the Mean | 0.49 | 2-Sided | 95 | -1.6 | 0.4 | Asenapine 5 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 7 | MMRM | 0.5060 | Unadjusted p-value | LS means difference | -0.4 | Standard Error of the Mean | 0.63 | 2-Sided | 95 | -1.7 | 0.8 | Olanzapine 15 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 14 | MMRM | 0.9956 | Unadjusted p-value | LS means difference | -0.0 | Standard Error of the Mean | 0.56 | 2-Sided | 95 | -1.1 | 1.1 | Asenapine 2.5 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 14 | MMRM | 0.1624 | Unadjusted p-value | LS means difference | -0.7 | Standard Error of the Mean | 0.53 | 2-Sided | 95 | -1.8 | 0.3 | Asenapine 5 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 14 | MMRM | 0.7662 | Unadjusted p-value | LS means difference | -0.2 | Standard Error of the Mean | 0.68 | 2-Sided | 95 | -1.5 | 1.1 | Olanzapine 15 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 21 | MMRM | 0.8363 | Unadjusted p-value | LS means difference | -0.1 | Standard Error of the Mean | 0.61 | 2-Sided | 95 | -1.3 | 1.1 | Asenapine 2.5 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 21 | MMRM | 0.2388 | Unadjusted p-value | LS means difference | -0.7 | Standard Error of the Mean | 0.58 | 2-Sided | 95 | -1.8 | 0.5 | Asenapine 5 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 21 | MMRM | 0.9435 | Unadjusted p-value | LS means difference | -0.1 | Standard Error of the Mean | 0.73 | 2-Sided | 95 | -1.5 | 1.4 | Olanzapine 15 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 28 | MMRM | 0.4267 | Unadjusted p-value | LS means difference | 0.6 | Standard Error of the Mean | 0.70 | 2-Sided | 95 | -0.8 | 1.9 | Asenapine 2.5 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 28 | MMRM | 0.6810 | Unadjusted p-value | LS means difference | -0.3 | Standard Error of the Mean | 0.65 | 2-Sided | 95 | -1.6 | 1.0 | Asenapine 5 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 28 | MMRM | 0.7673 | Unadjusted p-value | LS means difference | 0.2 | Standard Error of the Mean | 0.82 | 2-Sided | 95 | -1.4 | 1.9 | Olanzapine 15 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 35 | MMRM | 0.4830 | Unadjusted p-value | LS means difference | -0.5 | Standard Error of the Mean | 0.70 | 2-Sided | 95 | -1.9 | 0.9 | Asenapine 2.5 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 35 | MMRM | 0.2128 | Unadjusted p-value | LS means difference | -0.8 | Standard Error of the Mean | 0.66 | 2-Sided | 95 | -2.1 | 0.5 | Asenapine 5 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 35 | MMRM | 0.1756 | Unadjusted p-value | LS means difference | -1.1 | Standard Error of the Mean | 0.83 | 2-Sided | 95 | -2.8 | 0.5 | Olanzapine 15 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 42 | MMRM | 0.4246 | Unadjusted p-value | LS means difference | 0.6 | Standard Error of the Mean | 0.72 | 2-Sided | 95 | -0.8 | 2.0 | Asenapine 2.5 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 42 | MMRM | 0.2873 | Unadjusted p-value | LS means difference | -0.7 | Standard Error of the Mean | 0.68 | 2-Sided | 95 | -2.1 | 0.6 | Asenapine 5 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 42 | MMRM | 0.7308 | Unadjusted p-value | LS means difference | -0.3 | Standard Error of the Mean | 0.83 | 2-Sided | 95 | -1.9 | 1.4 | Olanzapine 15 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 7 |
|
| Day 14 |
|
| Day 21 |
|
| Day 28 |
|
| Day 35 |
|
| Day 42 |
|
Day 4 |
| MMRM |
| 0.9039 |
Unadjusted p-value |
| LS means difference |
| 0.0 |
| Standard Error of the Mean |
| 0.31 |
| 2-Sided |
| 95 |
| -0.6 |
| 0.7 |
Asenapine 5 mg BID minus Placebo BID |
| Superiority or Other (legacy) |
| Day 4 | MMRM | 0.2959 | Unadjusted p-value | LS means difference | -0.4 | Standard Error of the Mean | 0.4 | 2-Sided | 95 | -1.2 | 0.4 | Olanzapine 15 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 7 | MMRM | 0.5909 | Unadjusted p-value | LS means difference | -0.2 | Standard Error of the Mean | 0.44 | 2-Sided | 95 | -1.1 | 0.6 | Asenapine 2.5 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 7 | MMRM | 0.1489 | Unadjusted p-value | LS means difference | -0.6 | Standard Error of the Mean | 0.42 | 2-Sided | 95 | -1.4 | 0.2 | Asenapine 5 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 7 | MMRM | 0.1000 | Unadjusted p-value | LS means difference | -0.9 | Standard Error of the Mean | 0.54 | 2-Sided | 95 | -2.0 | 0.2 | Olanzapine 15 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 14 | MMRM | 0.7830 | Unadjusted p-value | LS means difference | 0.1 | Standard Error of the Mean | 0.49 | 2-Sided | 95 | -0.8 | 1.1 | Asenapine 2.5 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 14 | MMRM | 0.2679 | Unadjusted p-value | LS means difference | -0.5 | Standard Error of the Mean | 0.47 | 2-Sided | 95 | -1.4 | 0.4 | Asenapine 5 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 14 | MMRM | 0.2321 | Unadjusted p-value | LS means difference | -0.7 | Standard Error of the Mean | 0.60 | 2-Sided | 95 | -1.9 | 0.5 | Olanzapine 15 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 21 | MMRM | 0.7368 | Unadjusted p-value | LS means difference | -0.2 | Standard Error of the Mean | 0.56 | 2-Sided | 95 | -1.3 | 0.9 | Asenapine 2.5 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 21 | MMRM | 0.4606 | Unadjusted p-value | LS means difference | -0.4 | Standard Error of the Mean | 0.53 | 2-Sided | 95 | -1.4 | 0.7 | Asenapine 5 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 21 | MMRM | 0.3241 | Unadjusted p-value | LS means difference | -0.7 | Standard Error of the Mean | 0.66 | 2-Sided | 95 | -2.0 | 0.7 | Olanzapine 15 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 28 | MMRM | 0.9860 | Unadjusted p-value | LS means difference | -0.0 | Standard Error of the Mean | 0.57 | 2-Sided | 95 | -1.1 | 1.1 | Asenapine 2.5 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 28 | MMRM | 0.1890 | Unadjusted p-value | LS means difference | -0.7 | Standard Error of the Mean | 0.53 | 2-Sided | 95 | -1.8 | 0.3 | Asenapine 5 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 28 | MMRM | 0.3030 | Unadjusted p-value | LS means difference | -0.7 | Standard Error of the Mean | 0.67 | 2-Sided | 95 | -2.0 | 0.6 | Olanzapine 15 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 35 | MMRM | 0.0550 | Unadjusted p-value | LS means difference | -1.1 | Standard Error of the Mean | 0.58 | 2-Sided | 95 | -2.3 | 0.0 | Asenapine 2.5 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 35 | MMRM | 0.0415 | Unadjusted p-value | LS means difference | -1.1 | Standard Error of the Mean | 0.55 | 2-Sided | 95 | -2.2 | -0.0 | Asenapine 5 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 35 | MMRM | 0.0058 | Unadjusted p-value | LS means difference | -1.9 | Standard Error of the Mean | 0.69 | 2-Sided | 95 | -3.3 | -0.6 | Olanzapine 15 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 42 | MMRM | 0.0691 | Unadjusted p-value | LS means difference | -1.1 | Standard Error of the Mean | 0.62 | 2-Sided | 95 | -2.3 | 0.1 | Asenapine 2.5 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 42 | MMRM | 0.0063 | Unadjusted p-value | LS means difference | -1.6 | Standard Error of the Mean | 0.58 | 2-Sided | 95 | -2.7 | -0.5 | Asenapine 5 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 42 | MMRM | 0.0056 | Unadjusted p-value | LS means difference | -2.0 | Standard Error of the Mean | 0.71 | 2-Sided | 95 | -3.4 | -0.6 | Olanzapine 15 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 7 |
|
| Day 14 |
|
| Day 21 |
|
| Day 28 |
|
| Day 35 |
|
| Day 42 |
|
Day 4 |
| MMRM |
| 0.5859 |
Unadjusted p-value |
| LS means difference |
| 0.2 |
| Standard Error of the Mean |
| 0.33 |
| 2-Sided |
| 95 |
| -0.5 |
| 0.8 |
Asenapine 5 mg BID minus Placebo BID |
| Superiority or Other (legacy) |
| Day 4 | MMRM | 0.6413 | Unadjusted p-value | LS means difference | -0.2 | Standard Error of the Mean | 0.43 | 2-Sided | 95 | -1.0 | 0.6 | Olanzapine 15 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 7 | MMRM | 0.7307 | Unadjusted p-value | LS means difference | 0.1 | Standard Error of the Mean | 0.38 | 2-Sided | 95 | -0.6 | 0.9 | Asenapine 2.5 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 7 | MMRM | 0.7176 | Unadjusted p-value | LS means difference | 0.1 | Standard Error of the Mean | 0.37 | 2-Sided | 95 | -0.6 | 0.9 | Asenapine 5 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 7 | MMRM | 0.4860 | Unadjusted p-value | LS means difference | -0.3 | Standard Error of the Mean | 0.48 | 2-Sided | 95 | -1.3 | 0.6 | Olanzapine 15 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 14 | MMRM | 0.9321 | Unadjusted p-value | LS means difference | -0.0 | Standard Error of the Mean | 0.41 | 2-Sided | 95 | -0.8 | 0.8 | Asenapine 2.5 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 14 | MMRM | 0.7691 | Unadjusted p-value | LS means difference | 0.1 | Standard Error of the Mean | 0.39 | 2-Sided | 95 | -0.7 | 0.9 | Asenapine 5 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 14 | MMRM | 0.5694 | Unadjusted p-value | LS means difference | -0.3 | Standard Error of the Mean | 0.50 | 2-Sided | 95 | -1.3 | 0.7 | Olanzapine 15 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 21 | MMRM | 0.5583 | Unadjusted p-value | LS means difference | 0.3 | Standard Error of the Mean | 0.45 | 2-Sided | 95 | -0.6 | 1.2 | Asenapine 2.5 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 21 | MMRM | 0.7307 | Unadjusted p-value | LS means difference | 0.1 | Standard Error of the Mean | 0.43 | 2-Sided | 95 | -0.7 | 1.0 | Asenapine 5 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 21 | MMRM | 0.1715 | Unadjusted p-value | LS means difference | -0.7 | Standard Error of the Mean | 0.54 | 2-Sided | 95 | -1.8 | 0.3 | Olanzapine 15 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 28 | MMRM | 0.4219 | Unadjusted p-value | LS means difference | 0.4 | Standard Error of the Mean | 0.55 | 2-Sided | 95 | -0.6 | 1.5 | Asenapine 2.5 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 28 | MMRM | 0.7437 | Unadjusted p-value | LS means difference | 0.2 | Standard Error of the Mean | 0.52 | 2-Sided | 95 | -0.9 | 1.2 | Asenapine 5 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 28 | MMRM | 0.3110 | Unadjusted p-value | LS means difference | -0.7 | Standard Error of the Mean | 0.65 | 2-Sided | 95 | -1.9 | 0.6 | Olanzapine 15 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 35 | MMRM | 0.9805 | Unadjusted p-value | LS means difference | -0.0 | Standard Error of the Mean | 0.50 | 2-Sided | 95 | -1.0 | 1.0 | Asenapine 2.5 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 35 | MMRM | 0.8741 | Unadjusted p-value | LS means difference | -0.1 | Standard Error of the Mean | 0.47 | 2-Sided | 95 | -1.0 | 0.8 | Asenapine 5 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 35 | MMRM | 0.3288 | Unadjusted p-value | LS means difference | -0.6 | Standard Error of the Mean | 0.58 | 2-Sided | 95 | -1.7 | 0.6 | Olanzapine 15 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 42 | MMRM | 0.9336 | Unadjusted p-value | LS means difference | 0.0 | Standard Error of the Mean | 0.56 | 2-Sided | 95 | -1.0 | 1.1 | Asenapine 2.5 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 42 | MMRM | 0.1722 | Unadjusted p-value | LS means difference | -0.7 | Standard Error of the Mean | 0.52 | 2-Sided | 95 | -1.7 | 0.3 | Asenapine 5 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 42 | MMRM | 0.1909 | Unadjusted p-value | LS means difference | -0.8 | Standard Error of the Mean | 0.64 | 2-Sided | 95 | -2.1 | 0.4 | Olanzapine 15 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 7 |
|
| Day 14 |
|
| Day 21 |
|
| Day 28 |
|
| Day 35 |
|
| Day 42 |
|
Day 4 |
| MMRM |
| 0.4912 |
Unadjusted p-value |
| LS means difference |
| -0.2 |
| Standard Error of the Mean |
| 0.36 |
| 2-Sided |
| 95 |
| -0.9 |
| 0.5 |
Asenapine 5 mg BID minus Placebo BID |
| Superiority or Other (legacy) |
| Day 4 | MMRM | 0.8559 | Unadjusted p-value | LS means difference | -0.1 | Standard Error of the Mean | 0.46 | 2-Sided | 95 | -1.0 | 0.8 | Olanzapine 15 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 7 | MMRM | 0.5635 | Unadjusted p-value | LS means difference | 0.2 | Standard Error of the Mean | 0.41 | 2-Sided | 95 | -0.6 | 1.1 | Asenapine 2.5 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 7 | MMRM | 0.2321 | Unadjusted p-value | LS means difference | -0.5 | Standard Error of the Mean | 0.40 | 2-Sided | 95 | -1.3 | 0.3 | Asenapine 5 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 7 | MMRM | 0.8867 | Unadjusted p-value | LS means difference | -0.1 | Standard Error of the Mean | 0.52 | 2-Sided | 95 | -1.1 | 0.9 | Olanzapine 15 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 14 | MMRM | 0.1499 | Unadjusted p-value | LS means difference | 0.6 | Standard Error of the Mean | 0.42 | 2-Sided | 95 | -0.2 | 1.4 | Asenapine 2.5 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 14 | MMRM | 0.2860 | Unadjusted p-value | LS means difference | -0.4 | Standard Error of the Mean | 0.40 | 2-Sided | 95 | -1.2 | 0.4 | Asenapine 5 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 14 | MMRM | 0.8978 | Unadjusted p-value | LS means difference | -0.1 | Standard Error of the Mean | 0.51 | 2-Sided | 95 | -1.1 | 0.9 | Olanzapine 15 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 21 | MMRM | 0.0283 | Unadjusted p-value | LS means difference | 1.0 | Standard Error of the Mean | 0.44 | 2-Sided | 95 | 0.1 | 1.8 | Asenapine 2.5 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 21 | MMRM | 0.8667 | Unadjusted p-value | LS means difference | 0.1 | Standard Error of the Mean | 0.41 | 2-Sided | 95 | -0.7 | 0.9 | Asenapine 5 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 21 | MMRM | 0.5044 | Unadjusted p-value | LS means difference | 0.3 | Standard Error of the Mean | 0.52 | 2-Sided | 95 | -0.7 | 1.4 | Olanzapine 15 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 28 | MMRM | 0.0040 | Unadjusted p-value | LS means difference | 1.4 | Standard Error of the Mean | 0.49 | 2-Sided | 95 | 0.5 | 2.4 | Asenapine 2.5 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 28 | MMRM | 0.6330 | Unadjusted p-value | LS means difference | 0.2 | Standard Error of the Mean | 0.46 | 2-Sided | 95 | -0.7 | 1.1 | Asenapine 5 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 28 | MMRM | 0.2981 | Unadjusted p-value | LS means difference | 0.6 | Standard Error of the Mean | 0.57 | 2-Sided | 95 | -0.5 | 1.7 | Olanzapine 15 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 35 | MMRM | 0.6556 | Unadjusted p-value | LS means difference | 0.2 | Standard Error of the Mean | 0.45 | 2-Sided | 95 | -0.7 | 1.1 | Asenapine 2.5 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 35 | MMRM | 0.2889 | Unadjusted p-value | LS means difference | -0.5 | Standard Error of the Mean | 0.43 | 2-Sided | 95 | -1.3 | 0.4 | Asenapine 5 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 35 | MMRM | 0.9399 | Unadjusted p-value | LS means difference | -0.0 | Standard Error of the Mean | 0.53 | 2-Sided | 95 | -1.1 | 1.0 | Olanzapine 15 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 42 | MMRM | 0.8955 | Unadjusted p-value | LS means difference | 0.1 | Standard Error of the Mean | 0.54 | 2-Sided | 95 | -1.0 | 1.1 | Asenapine 2.5 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 42 | MMRM | 0.3681 | Unadjusted p-value | LS means difference | -0.5 | Standard Error of the Mean | 0.51 | 2-Sided | 95 | -1.5 | 0.5 | Asenapine 5 mg BID minus Placebo BID | Superiority or Other (legacy) |
| Day 42 | MMRM | 0.8215 | Unadjusted p-value | LS means difference | -0.1 | Standard Error of the Mean | 0.62 | 2-Sided | 95 | -1.4 | 1.1 | Olanzapine 15 mg BID minus Placebo BID | Superiority or Other (legacy) |