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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-017971-10 | EudraCT Number | ||
| MK-8274-020 | Other Identifier | Merck Research Laboratories | |
| CTRI/2011/07/001909 | Other Identifier | CTRI |
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This study is designed to evaluate whether asenapine, which is approved by the United States Food and Drug Administration (US FDA) for acute treatment of schizophrenia in adults, is also effective in adolescents with schizophrenia. Participants who qualify for the study will be randomly assigned to receive a fixed dose of asenapine (either 2.5 mg or 5 mg twice daily [BID]) or placebo for 8 weeks. Throughout the study, observations will be made on each participant at various times to assess the efficacy and safety of the study treatment. The primary objective of the trial is to demonstrate significant superiority of at least one asenapine dose to placebo, as measured by the change from baseline of the Positive and Negative Syndrome Scale (PANSS) total score at Day 56.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Asenapine 2.5 mg BID | Experimental | Participants receive active asenapine 2.5 mg tablets sublingually BID for 8 weeks. |
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| Asenapine 5.0 mg BID | Experimental | Participants receive active asenapine 2.5 mg tablets sublingually BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive active asenapine 5.0 mg tablets sublingually BID for the remainder of the 8-week treatment period. |
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| Placebo | Placebo Comparator | Participants receive placebo asenapine tablets sublingually BID for 8 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| asenapine 2.5 mg | Drug | asenapine 2.5 mg tablets for sublingual administration |
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| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 56 | The PANSS is a 30-item clinician-rated instrument for assessing the symptoms of schizophrenia. It consists of 3 subscales: positive subscale (7 items), negative subscale (7 items), and general psychopathology subscale (16 items). Positive symptoms refer to an excess or distortion of normal mental status (e.g., delusions). 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. The PANSS total score for each participant was calculated as the 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 56; improvement in symptoms is represented by negative values. | Baseline and Day 56 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score at Day 56 | Change from baseline in CGI-S score at Day 56 is the 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 56; improvement in symptoms is represented by negative values. |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26091193 | Result | Findling RL, Landbloom RP, Mackle M, Pallozzi W, Braat S, Hundt C, Wamboldt MZ, Mathews M. Safety and Efficacy from an 8 Week Double-Blind Trial and a 26 Week Open-Label Extension of Asenapine in Adolescents with Schizophrenia. J Child Adolesc Psychopharmacol. 2015 Jun;25(5):384-96. doi: 10.1089/cap.2015.0027. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants receive placebo asenapine tablets sublingually twice daily (BID) for 8 weeks |
| FG001 | Asenapine 2.5 mg BID | Participants receive active asenapine 2.5 mg tablets sublingually BID for 8 weeks |
| FG002 | Asenapine 5.0 mg BID | Participants receive active asenapine 2.5 mg tablets sublingually BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive active asenapine 5.0 mg tablets sublingually BID for the remainder of the 8-week treatment period |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants receive placebo asenapine tablets sublingually BID for 8 weeks |
| BG001 | Asenapine 2.5 mg BID | Participants receive active asenapine 2.5 mg tablets sublingually BID for 8 weeks |
| 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 Positive and Negative Syndrome Scale (PANSS) Total Score at Day 56 | The PANSS is a 30-item clinician-rated instrument for assessing the symptoms of schizophrenia. It consists of 3 subscales: positive subscale (7 items), negative subscale (7 items), and general psychopathology subscale (16 items). Positive symptoms refer to an excess or distortion of normal mental status (e.g., delusions). 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. The PANSS total score for each participant was calculated as the 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 56; improvement in symptoms is represented by negative values. | Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment PANSS Total Score (this group is termed the efficacy Full Analysis Set [FAS]); also, to be included an on-treatment Day 56 value of PANSS Total Score must be available for a participant. | Posted | Mean | Standard Deviation | score on a scale | Baseline and Day 56 |
Up to 30 days after the last dose of study drug
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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 | Placebo | Participants receive placebo asenapine tablets sublingually BID for 8 weeks |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Schizophrenia | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Somnolence | Nervous system disorders | MedDRA 15.1 | 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 |
|---|---|
| D012563 | Schizophrenia, Paranoid |
| D012562 | Schizophrenia, Disorganized |
| D012559 | Schizophrenia |
| D012734 | Disorders of Sex Development |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
| D014564 | Urogenital Abnormalities |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| C522667 | asenapine |
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| asenapine 5.0 mg | Drug | asenapine 5.0 mg tablets for sublingual administration |
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| placebo | Drug | asenapine-matched placebo tablets for sublingual administration |
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| Baseline and Day 56 |
| Change From Baseline in PANSS Positive Subscale Score at Day 56 | 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 the symptoms of schizophrenia. 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. The PANSS positive subscale score for each participant was calculated as the 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. The reported measure is the change from baseline at Day 56; improvement in symptoms is represented by negative values. | Baseline and Day 56 |
| Change From Baseline in PANSS Negative Subscale Score at Day 56 | 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 the symptoms of schizophrenia. 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. The PANSS negative subscale score for each participant was calculated as the 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. The reported measure is the change from baseline at Day 56; improvement in symptoms is represented by negative values. | Baseline and Day 56 |
| Change From Baseline in PANSS Positive and Negative Subscale Scores Combined at Day 56 | This measure reports results for the combined positive subscale (7 items) and negative subscale (7 items) of the PANSS, which is a 30-item clinician-rated instrument used to assess the symptoms of schizophrenia. Positive symptoms refer to an excess or distortion of normal mental status (e.g., delusions). Negative symptoms represent a diminution or loss of normal functions (e.g., emotional withdrawal). For each of the total 14 items in the combined positive and negative subscales, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The PANSS positive and negative subscale scores combined for each participant was calculated as the sum of the rating assigned to each of the 14 combined subscale items, and ranged from 14 to 98 with a higher score indicating greater severity of symptoms. The reported measure is the change from baseline at Day 56; improvement in symptoms is represented by negative values. | Baseline and Day 56 |
| Change From Baseline in PANSS General Psychopathology Subscale Score at Day 56 | 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 at Day 56; improvement in symptoms is represented by negative values. | Baseline and Day 56 |
| Change From Baseline in PANSS Marder Positive Symptoms Factor Score at Day 56 | This measure reports results for the 8 items of the Marder positive symptoms factor of the PANSS, which is a 30-item clinician-rated instrument used to assess the symptoms of schizophrenia. Marder factors are a modified grouping of the 30 PANSS items (Marder et al. J Clin Psychiatry 1997;58(12):538-46). 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. The PANSS Marder positive symptoms factor score for each participant was calculated as the sum of the 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. The reported measure is the change from baseline at Day 56; improvement in symptoms is represented by negative values. | Baseline and Day 56 |
| Change From Baseline in PANSS Marder Negative Symptoms Factor Score at Day 56 | 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 the symptoms of schizophrenia. Marder factors are a modified grouping of the 30 PANSS items. 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. The PANSS Marder negative symptoms factor score for each participant was calculated as the 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. The reported measure is the change from baseline at Day 56; improvement in symptoms is represented by negative values. | Baseline and Day 56 |
| Change From Baseline in PANSS Marder Disorganized Thoughts Factor Score at Day 56 | 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 the symptoms of schizophrenia. 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. The PANSS Marder disorganized thoughts factor score for each participant was calculated as the 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. The reported measure is the change from baseline at Day 56; improvement in symptoms is represented by negative values. | Baseline and Day 56 |
| Change From Baseline in PANSS Marder Hostility/Excitement Factor Score at Day 56 | 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 the symptoms of schizophrenia. 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. The PANSS Marder hostility/excitement factor score for each participant was calculated as the sum of the 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. The reported measure is the change from baseline at Day 56; improvement in symptoms is represented by negative values. | Baseline and Day 56 |
| Change From Baseline in PANSS Marder Anxiety/Depression Factor Score at Day 56 | 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 the symptoms of schizophrenia. 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. The PANSS Marder anxiety/depression factor score for each participant was calculated as the sum of the 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. The reported measure is the change from baseline at Day 56; improvement in symptoms is represented by negative values. | Baseline and Day 56 |
| Total PANSS 30% Responders | A Total PANSS 30% responder was defined as a participant who had a reduction from baseline of at least 30% in the PANSS Total score at the last available assessment of the study for that participant (i.e., endpoint). The PANSS is a 30-item clinician-rated instrument for assessing the symptoms of schizophrenia. 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. | Baseline up to Day 56 |
| Kaplan-Meier Estimate of Cumulative Percentage of Participants With Total PANSS 30% Response at End of Study | A total PANSS 30% response was defined as a reduction from baseline of at least 30% in the PANSS Total score. The PANSS is a 30-item clinician-rated instrument for assessing the symptoms of schizophrenia. 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. The Kaplan-Meier estimate reports the cumulative percentage of participants with total PANSS 30% response from first drug intake up to approximately Day 59. | Baseline up to approximately Day 59 |
| Clinical Global Impression of Improvement (CGI-I) Score at Day 56 | 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. | Baseline and Day 56 |
| CGI-I Responders | 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 the last available assessment of the study for that participant (i.e., endpoint). 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. | Baseline up to Day 56 |
| Kaplan-Meier Estimate of Cumulative Percentage of Participants With CGI-I Response at End of Study | CGI-I response was defined as the occurrence of a CGI-I score of 1 (very much improved) or 2 (much improved). 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. The Kaplan-Meier estimate reports the cumulative percentage of participants with CGI-I response from first drug intake up to approximately Day 58. | Baseline up to approximately Day 58 |
| Change From Baseline in Children's Global Assessment Scale (CGAS) Score at Day 56 | CGAS is a 100-point scale measuring psychological, social, and school functioning in children aged 6-17. Minimum scores ranged from 1-10, representing the need for constant supervision (worse result) to maximum scores of 91-100, representing superior functioning (better result). The reported measure is the change from baseline at Day 56; improvement in functioning is represented by positive values. | Baseline and Day 56 |
| Change From Baseline in Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q) Total Score at Day 56 | PQ-LES-Q is a questionnaire to assess quality of life enjoyment and satisfaction in children and adolescents. The participant is asked to rate 15 items reflecting quality of life with respect to the previous week on a scale of 1=very poor to 5=very good. Items 1-14 assess specific areas (e.g., your health, your mood or feelings); Item 15 is a global assessment of overall quality of life. The PQ-LES-Q total score for each participant was calculated as the sum of the rating assigned to each of the first 14 items, and ranged from 14 to 70 with a higher score indicating better quality of life. The reported measure is the change from baseline at Day 56; improvement in quality of life is represented by positive values. This analysis used a last-observation-carried-forward (LOCF) approach; if no Day 56 value was available for a participant, the last available assessment prior to the Day 56 assessment was used. | Baseline and Day 56 |
| Change From Baseline in PQ-LES-Q Overall Score (i.e., Item 15) at Day 56 | PQ-LES-Q is a questionnaire to assess quality of life enjoyment and satisfaction in children and adolescents. The participant is asked to rate 15 items reflecting quality of life with respect to the previous week on a scale of 1=very poor to 5=very good. Items 1-14 assess specific areas (e.g., your health, your mood or feelings); Item 15 is a global assessment of overall quality of life. The Item 15 result is defined to be the PQ-LES-Q overall score, and ranged from 1 to 5 with a higher score indicating better quality of life. The reported measure is the change from baseline at Day 56; improvement in quality of life is represented by positive values. This analysis used an LOCF approach; if no Day 56 value was available for a participant, the last available assessment prior to the Day 56 assessment was used. | Baseline and Day 56 |
| Lost to Follow-up |
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| Withdrawal by Subject |
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| Protocol Violation |
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| Did not meet protocol eligibility |
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| BG002 | Asenapine 5.0 mg BID | Participants receive active asenapine 2.5 mg tablets sublingually BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive active asenapine 5.0 mg tablets sublingually BID for the remainder of the 8-week treatment period |
| BG003 | Total | Total of all reporting groups |
| years |
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| 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=100, 96, 104 and 300 for Placebo, asenapine 2.5 mg BID, asenapine 5.0 mg BID and Total groups, respectively. | Mean | Standard Deviation | score on a scale |
|
| Clinical Global Impression of 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=100, 96, 104 and 300 for Placebo, asenapine 2.5 mg BID, asenapine 5.0 mg 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=100, 96, 104 and 300 for Placebo, asenapine 2.5 mg BID, asenapine 5.0 mg BID and Total groups, respectively. | Mean | Standard Deviation | score on a scale |
|
| 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=100, 96, 104 and 300 for Placebo, asenapine 2.5 mg BID, asenapine 5.0 mg BID and Total groups, respectively. | Mean | Standard Deviation | score on a scale |
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| PANSS positive and negative subscale scores combined | 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 and negative subscale scores combined (14 PANSS items) ranged from 14 to 98 with a higher score indicating greater severity of symptoms. Summary statistics presented are for efficacy population (FAS): N=100, 96, 104 and 300 for Placebo, asenapine 2.5 mg BID, asenapine 5.0 mg 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=100, 96, 104 and 300 for Placebo, asenapine 2.5 mg BID, asenapine 5.0 mg BID and Total groups, respectively. | Mean | Standard Deviation | score on a scale |
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| PANSS Marder positive symptoms factor 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 positive symptoms factor 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=100, 96, 104 and 300 for Placebo, asenapine 2.5 mg BID, asenapine 5.0 mg BID and Total groups, respectively. | Mean | Standard Deviation | score on a scale |
|
| PANSS Marder negative symptoms factor 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 negative symptoms factor 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=100, 96, 104 and 300 for Placebo, asenapine 2.5 mg BID, asenapine 5.0 mg BID and Total groups, respectively. | Mean | Standard Deviation | score on a scale |
|
| PANSS Marder disorganized thoughts factor 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 disorganized thoughts factor 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=100, 96, 104 and 300 for Placebo, asenapine 2.5 mg BID, asenapine 5.0 mg BID and Total groups, respectively. | Mean | Standard Deviation | score on a scale |
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| PANSS Marder hostility/excitement factor 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 hostility/excitement factor 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=100, 96, 104 and 300 for Placebo, asenapine 2.5 mg BID, asenapine 5.0 mg BID and Total groups, respectively. | Mean | Standard Deviation | score on a scale |
|
| PANSS Marder anxiety/depression factor 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 anxiety/depression factor 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=100, 96, 104 and 300 for Placebo, asenapine 2.5 mg BID, asenapine 5.0 mg BID and Total groups, respectively. | Mean | Standard Deviation | score on a scale |
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| Children's Global Assessment Scale (CGAS) score - current functioning | CGAS is a 100-point scale measuring psychological, social, and school functioning in children aged 6-17. Minimum scores ranged from 1-10, representing the need for constant supervision (worse result) to maximum scores of 91-100, representing superior functioning (better result). Summary statistics presented are for efficacy population (FAS) except as noted: N=99 (baseline value not available for 1 FAS participant in this group), 96, 104 and 299 for Placebo, asenapine 2.5 mg BID, asenapine 5.0 mg BID and Total groups, respectively. | Mean | Standard Deviation | score on a scale |
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| Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q) total score | PQ-LES-Q is a questionnaire to assess quality of life enjoyment and satisfaction in children and adolescents. The participant is asked to rate 15 items reflecting quality of life with respect to the previous week on a scale of 1=very poor to 5=very good. The PQ-LES-Q total score (sum of Items 1-14) for each participant ranged from 14 to 70 with a higher score indicating better quality of life. Summary statistics presented are for efficacy population (FAS): N=100, 96, 104 and 300 for Placebo, asenapine 2.5 mg BID, asenapine 5.0 mg BID and Total groups, respectively. | Mean | Standard Deviation | score on a scale |
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| PQ-LES-Q overall score | PQ-LES-Q is a questionnaire to assess quality of life enjoyment and satisfaction in children and adolescents. The participant is asked to rate 15 items reflecting quality of life with respect to the previous week on a scale of 1=very poor to 5=very good. The PQ-LES-Q overall score (Item 15, a global assessment of quality of life) ranged from 1 to 5 with a higher score indicating better quality of life. Summary statistics presented are for efficacy population (FAS): N=100, 96, 104 and 300 for Placebo, asenapine 2.5 mg BID, asenapine 5.0 mg BID and Total groups, respectively. | Mean | Standard Deviation | score on a scale |
|
| ID | Title | Description |
|---|---|---|
| OG000 | Placebo | Participants receive placebo asenapine tablets sublingually BID for 8 weeks |
| OG001 | Asenapine 2.5 mg BID | Participants receive active asenapine 2.5 mg tablets sublingually BID for 8 weeks |
| OG002 | Asenapine 5.0 mg BID | Participants receive active asenapine 2.5 mg tablets sublingually BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive active asenapine 5.0 mg tablets sublingually BID for the remainder of the 8-week treatment period |
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| Secondary | Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score at Day 56 | Change from baseline in CGI-S score at Day 56 is the 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 56; improvement in symptoms is represented by negative values. | Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment PANSS Total Score (this group is termed the efficacy FAS); also, to be included a baseline and an on-treatment Day 56 value of the CGI-S score must be available for a participant. | Posted | Mean | Standard Deviation | score on a scale | Baseline and Day 56 |
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| Secondary | Change From Baseline in PANSS Positive Subscale Score at Day 56 | 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 the symptoms of schizophrenia. 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. The PANSS positive subscale score for each participant was calculated as the 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. The reported measure is the change from baseline at Day 56; improvement in symptoms is represented by negative values. | Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment PANSS Total Score (this group is termed the efficacy FAS); also, to be included a baseline and an on-treatment Day 56 value of the PANSS positive subscale score must be available for a participant. | Posted | Mean | Standard Deviation | score on a scale | Baseline and Day 56 |
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| Secondary | Change From Baseline in PANSS Negative Subscale Score at Day 56 | 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 the symptoms of schizophrenia. 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. The PANSS negative subscale score for each participant was calculated as the 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. The reported measure is the change from baseline at Day 56; improvement in symptoms is represented by negative values. | Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment PANSS Total Score (this group is termed the efficacy FAS); also, to be included a baseline and an on-treatment Day 56 value of the PANSS negative subscale score must be available for a participant. | Posted | Mean | Standard Deviation | score on a scale | Baseline and Day 56 |
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| Secondary | Change From Baseline in PANSS Positive and Negative Subscale Scores Combined at Day 56 | This measure reports results for the combined positive subscale (7 items) and negative subscale (7 items) of the PANSS, which is a 30-item clinician-rated instrument used to assess the symptoms of schizophrenia. Positive symptoms refer to an excess or distortion of normal mental status (e.g., delusions). Negative symptoms represent a diminution or loss of normal functions (e.g., emotional withdrawal). For each of the total 14 items in the combined positive and negative subscales, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The PANSS positive and negative subscale scores combined for each participant was calculated as the sum of the rating assigned to each of the 14 combined subscale items, and ranged from 14 to 98 with a higher score indicating greater severity of symptoms. The reported measure is the change from baseline at Day 56; improvement in symptoms is represented by negative values. | Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment PANSS Total Score (this group is termed the efficacy FAS); also, to be included a baseline and an on-treatment Day 56 value of the PANSS positive/negative subscale scores combined must be available for a participant. | Posted | Mean | Standard Deviation | score on a scale | Baseline and Day 56 |
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| Secondary | Change From Baseline in PANSS General Psychopathology Subscale Score at Day 56 | 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 at Day 56; improvement in symptoms is represented by negative values. | Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment PANSS Total Score (this group is termed the efficacy FAS); also, to be included a baseline and an on-treatment Day 56 value of the PANSS general psychopathology subscale score must be available for a participant. | Posted | Mean | Standard Deviation | score on a scale | Baseline and Day 56 |
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| Secondary | Change From Baseline in PANSS Marder Positive Symptoms Factor Score at Day 56 | This measure reports results for the 8 items of the Marder positive symptoms factor of the PANSS, which is a 30-item clinician-rated instrument used to assess the symptoms of schizophrenia. Marder factors are a modified grouping of the 30 PANSS items (Marder et al. J Clin Psychiatry 1997;58(12):538-46). 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. The PANSS Marder positive symptoms factor score for each participant was calculated as the sum of the 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. The reported measure is the change from baseline at Day 56; improvement in symptoms is represented by negative values. | Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment PANSS Total Score (this group is termed the efficacy FAS); also, to be included a baseline and an on-treatment Day 56 value of the PANSS Marder positive symptoms factor score must be available for a participant. | Posted | Mean | Standard Deviation | score on a scale | Baseline and Day 56 |
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| Secondary | Change From Baseline in PANSS Marder Negative Symptoms Factor Score at Day 56 | 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 the symptoms of schizophrenia. Marder factors are a modified grouping of the 30 PANSS items. 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. The PANSS Marder negative symptoms factor score for each participant was calculated as the 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. The reported measure is the change from baseline at Day 56; improvement in symptoms is represented by negative values. | Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment PANSS Total Score (this group is termed the efficacy FAS); also, to be included a baseline and an on-treatment Day 56 value of the PANSS Marder negative symptoms factor score must be available for a participant. | Posted | Mean | Standard Deviation | score on a scale | Baseline and Day 56 |
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| Secondary | Change From Baseline in PANSS Marder Disorganized Thoughts Factor Score at Day 56 | 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 the symptoms of schizophrenia. 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. The PANSS Marder disorganized thoughts factor score for each participant was calculated as the 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. The reported measure is the change from baseline at Day 56; improvement in symptoms is represented by negative values. | Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment PANSS Total Score (this group is termed the efficacy FAS); also, to be included a baseline and an on-treatment Day 56 value of the PANSS Marder disorganized thoughts factor score must be available for a participant. | Posted | Mean | Standard Deviation | score on a scale | Baseline and Day 56 |
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| Secondary | Change From Baseline in PANSS Marder Hostility/Excitement Factor Score at Day 56 | 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 the symptoms of schizophrenia. 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. The PANSS Marder hostility/excitement factor score for each participant was calculated as the sum of the 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. The reported measure is the change from baseline at Day 56; improvement in symptoms is represented by negative values. | Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment PANSS Total Score (this group is termed the efficacy FAS); also, to be included a baseline and an on-treatment Day 56 value of the PANSS Marder hostility/excitement factor score must be available for a participant. | Posted | Mean | Standard Deviation | score on a scale | Baseline and Day 56 |
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| Secondary | Change From Baseline in PANSS Marder Anxiety/Depression Factor Score at Day 56 | 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 the symptoms of schizophrenia. 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. The PANSS Marder anxiety/depression factor score for each participant was calculated as the sum of the 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. The reported measure is the change from baseline at Day 56; improvement in symptoms is represented by negative values. | Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment PANSS Total Score (this group is termed the efficacy FAS); also, to be included a baseline and an on-treatment Day 56 value of the PANSS Marder anxiety/depression factor score must be available for a participant. | Posted | Mean | Standard Deviation | score on a scale | Baseline and Day 56 |
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| Secondary | Total PANSS 30% Responders | A Total PANSS 30% responder was defined as a participant who had a reduction from baseline of at least 30% in the PANSS Total score at the last available assessment of the study for that participant (i.e., endpoint). The PANSS is a 30-item clinician-rated instrument for assessing the symptoms of schizophrenia. 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. | Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment PANSS Total Score (this group is termed the efficacy FAS). | Posted | Number | participants | Baseline up to Day 56 |
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| Secondary | Kaplan-Meier Estimate of Cumulative Percentage of Participants With Total PANSS 30% Response at End of Study | A total PANSS 30% response was defined as a reduction from baseline of at least 30% in the PANSS Total score. The PANSS is a 30-item clinician-rated instrument for assessing the symptoms of schizophrenia. 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. The Kaplan-Meier estimate reports the cumulative percentage of participants with total PANSS 30% response from first drug intake up to approximately Day 59. | Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment PANSS Total Score (this group is termed the efficacy FAS). | Posted | Number | cumulative % of participants w/ Response | Baseline up to approximately Day 59 |
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| Secondary | Clinical Global Impression of Improvement (CGI-I) Score at Day 56 | 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. | Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment PANSS Total Score (this group is termed the efficacy FAS); also, to be included an on-treatment Day 56 value of the CGI-I score must be available for a participant. | Posted | Mean | Standard Deviation | score on a scale | Baseline and Day 56 |
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| Secondary | CGI-I Responders | 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 the last available assessment of the study for that participant (i.e., endpoint). 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. | Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment PANSS Total Score (this group is termed the efficacy FAS). | Posted | Number | participants | Baseline up to Day 56 |
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| Secondary | Kaplan-Meier Estimate of Cumulative Percentage of Participants With CGI-I Response at End of Study | CGI-I response was defined as the occurrence of a CGI-I score of 1 (very much improved) or 2 (much improved). 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. The Kaplan-Meier estimate reports the cumulative percentage of participants with CGI-I response from first drug intake up to approximately Day 58. | Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment PANSS Total Score (this group is termed the efficacy FAS). | Posted | Number | cumulative % of participants w/ Response | Baseline up to approximately Day 58 |
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| Secondary | Change From Baseline in Children's Global Assessment Scale (CGAS) Score at Day 56 | CGAS is a 100-point scale measuring psychological, social, and school functioning in children aged 6-17. Minimum scores ranged from 1-10, representing the need for constant supervision (worse result) to maximum scores of 91-100, representing superior functioning (better result). The reported measure is the change from baseline at Day 56; improvement in functioning is represented by positive values. | Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment PANSS Total Score (this group is termed the efficacy FAS); also, to be included a baseline and an on-treatment Day 56 value of the CGAS score must be available for a participant. | Posted | Mean | Standard Deviation | score on a scale | Baseline and Day 56 |
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| Secondary | Change From Baseline in Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q) Total Score at Day 56 | PQ-LES-Q is a questionnaire to assess quality of life enjoyment and satisfaction in children and adolescents. The participant is asked to rate 15 items reflecting quality of life with respect to the previous week on a scale of 1=very poor to 5=very good. Items 1-14 assess specific areas (e.g., your health, your mood or feelings); Item 15 is a global assessment of overall quality of life. The PQ-LES-Q total score for each participant was calculated as the sum of the rating assigned to each of the first 14 items, and ranged from 14 to 70 with a higher score indicating better quality of life. The reported measure is the change from baseline at Day 56; improvement in quality of life is represented by positive values. This analysis used a last-observation-carried-forward (LOCF) approach; if no Day 56 value was available for a participant, the last available assessment prior to the Day 56 assessment was used. | Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment PANSS Total Score (this group is termed the efficacy FAS); also, to be included a baseline and at least 1 post-baseline on-treatment value of the PQ-LES-Q total score must be available for a participant. | Posted | Mean | Standard Deviation | score on a scale | Baseline and Day 56 |
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| Secondary | Change From Baseline in PQ-LES-Q Overall Score (i.e., Item 15) at Day 56 | PQ-LES-Q is a questionnaire to assess quality of life enjoyment and satisfaction in children and adolescents. The participant is asked to rate 15 items reflecting quality of life with respect to the previous week on a scale of 1=very poor to 5=very good. Items 1-14 assess specific areas (e.g., your health, your mood or feelings); Item 15 is a global assessment of overall quality of life. The Item 15 result is defined to be the PQ-LES-Q overall score, and ranged from 1 to 5 with a higher score indicating better quality of life. The reported measure is the change from baseline at Day 56; improvement in quality of life is represented by positive values. This analysis used an LOCF approach; if no Day 56 value was available for a participant, the last available assessment prior to the Day 56 assessment was used. | Randomized participants who received at least 1 dose of study drug and had both a baseline and at least 1 post-baseline on-treatment PANSS Total Score (this group is termed the efficacy FAS); also, to be included a baseline and at least 1 post-baseline on-treatment value of the PQ-LES-Q overall score score must be available for a participant. | Posted | Mean | Standard Deviation | score on a scale | Baseline and Day 56 |
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| 3 |
| 102 |
| 23 |
| 102 |
| EG001 | Asenapine 2.5 mg BID | Participants receive active asenapine 2.5 mg tablets sublingually BID for 8 weeks | 3 | 98 | 39 | 98 |
| EG002 | Asenapine 5.0 mg BID | Participants receive active asenapine 2.5 mg tablets sublingually BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive active asenapine 5.0 mg tablets sublingually BID for the remainder of the 8-week treatment period | 3 | 106 | 46 | 106 |
| Hallucination, auditory | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
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| Typhoid fever | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
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| Sedation | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
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| Akathisia | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
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| Hypoaesthesia oral | Gastrointestinal disorders | MedDRA 15.1 | 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.
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
| Superiority or Other (legacy) |
| Confirmative testing for the key secondary endpoint was to be performed only if both asenapine doses were superior to placebo in change from baseline in PANSS total score at Day 56 (hypotheses associated with Primary outcome measure). If this did not occur, no confirmative testing could be performed and multiplicity unadjusted p-values are provided. Model uses efficacy FAS population (number of participants: placebo - 100, asenapine 2.5 mg - 96, asenapine - 104) | MMRM | Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit | 0.024 | Difference in LS Means | -0.3 | 95 | -0.6 | -0.0 | Estimate is asenapine versus placebo | Superiority or Other (legacy) |
| Model uses efficacy FAS population (number of participants: placebo - 100, asenapine 2.5 mg - 96, asenapine - 104) | MMRM | Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit | 0.012 | Difference in LS Means | -2.1 | 2-Sided | 95 | -3.8 | -0.5 | Estimate is asenapine versus placebo | Superiority or Other (legacy) |
| Model uses efficacy FAS population (number of participants: placebo - 100, asenapine 2.5 mg - 96, asenapine - 104) | MMRM | Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit | 0.099 | Difference in LS Means | -1.2 | 2-Sided | 95 | -2.6 | 0.2 | Estimate is asenapine versus placebo | Superiority or Other (legacy) |
| Model uses efficacy FAS population (number of participants: placebo - 100, asenapine 2.5 mg - 96, asenapine - 104) | MMRM | Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit | 0.025 | Difference in LS Means | -3.2 | 2-Sided | 95 | -6.0 | -0.4 | Estimate is asenapine versus placebo | Superiority or Other (legacy) |
| Model uses efficacy FAS population (number of participants: placebo - 100, asenapine 2.5 mg - 96, asenapine - 104) | MMRM | Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit | 0.071 | Difference in LS Means | -2.3 | 2-Sided | 95 | -4.8 | 0.2 | Estimate is asenapine versus placebo | Superiority or Other (legacy) |
| Model uses efficacy FAS population (number of participants: placebo - 100, asenapine 2.5 mg - 96, asenapine - 104) | MMRM | Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit | 0.026 | Difference in LS Means | -1.9 | 2-Sided | 95 | -3.6 | -0.2 | Estimate is asenapine versus placebo | Superiority or Other (legacy) |
| Model uses efficacy FAS population (number of participants: placebo - 100, asenapine 2.5 mg - 96, asenapine - 104) | MMRM | Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit | 0.067 | Difference in LS Means | -1.3 | 2-Sided | 95 | -2.7 | 0.1 | Estimate is asenapine versus placebo | Superiority or Other (legacy) |
| Model uses efficacy FAS population (number of participants: placebo - 100, asenapine 2.5 mg - 96, asenapine - 104) | MMRM | Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit | 0.135 | Difference in LS Means | -0.9 | 2-Sided | 95 | -2.1 | 0.3 | Estimate is asenapine versus placebo | Superiority or Other (legacy) |
| Model uses efficacy FAS population (number of participants: placebo - 100, asenapine 2.5 mg - 96, asenapine - 104) | MMRM | Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit | 0.120 | Difference in LS Means | -0.8 | 2-Sided | 95 | -1.9 | 0.2 | Estimate is asenapine versus placebo | Superiority or Other (legacy) |
| Model uses efficacy FAS population (number of participants: placebo - 100, asenapine 2.5 mg - 96, asenapine - 104) | MMRM | Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit | 0.146 | Difference in LS Means | -0.5 | 2-Sided | 95 | -1.3 | 0.2 | Estimate is asenapine versus placebo | Superiority or Other (legacy) |
| Regression, Logistic | Model included terms of (pooled) site, treatment, and baseline PANSS Total Score | 0.048 | 95% Confidence Interval and p-value are based on Wald statistic | Odds Ratio (OR) | 1.8 | 2-Sided | 95 | 1.0 | 3.3 | OR was adjusted for baseline and (pooled) site. An OR of >1 is considered to mean that asenapine has a higher probability of achieving Total PANSS 30% response | Superiority or Other (legacy) |
Model included factors for (pooled) site, treatment and baseline PANSS Total Score |
| 0.171 |
| Hazard Ratio (HR) |
| 1.3 |
| 2-Sided |
| 95 |
| 0.9 |
| 2.0 |
An HR of >1 is considered to mean that asenapine has a higher likelihood of being a Total PANSS 30% Responder than placebo |
| Superiority or Other (legacy) |
| Regression, Cox | Model included factors for (pooled) site, treatment and baseline PANSS Total Score | 0.368 | Hazard Ratio (HR) | 1.2 | 2-Sided | 95 | 0.8 | 1.8 | An HR of >1 is considered to mean that asenapine has a higher likelihood of being a Total PANSS 30% Responder than placebo | Superiority or Other (legacy) |
|
Model uses efficacy FAS population (number of participants: placebo - 100, asenapine 2.5 mg - 96, asenapine - 104) |
| MMRM |
Model included terms of (pooled) site, treatment, visit, and the interaction of visit by treatment |
| 0.003 |
| Difference in LS Means |
| -0.5 |
| 2-Sided |
| 95 |
| -0.8 |
| -0.2 |
Estimate is asenapine versus placebo |
| Superiority or Other (legacy) |
| Regression, Logistic | Model included terms of region (Asia-Pacific, North America, Eastern Europe [Africa/Latin America sites assigned to this region]) and treatment | 0.114 | 95% Confidence Interval and p-value are based on Wald statistic | Odds Ratio (OR) | 1.6 | 2-Sided | 95 | 0.9 | 2.9 | OR was adjusted for region. An OR of >1 is considered to mean that asenapine has a higher probability of achieving CGI-I response | Superiority or Other (legacy) |
Model included factors for (pooled) site and treatment |
| 0.135 |
| Hazard Ratio (HR) |
| 1.4 |
| 2-Sided |
| 95 |
| 0.9 |
| 2.3 |
An HR of >1 is considered to mean that asenapine has a higher likelihood of being a CGI-I Responder than placebo |
| Superiority or Other (legacy) |
| Regression, Cox | Model included factors for (pooled) site and treatment | 0.010 | Hazard Ratio (HR) | 1.8 | 2-Sided | 95 | 1.2 | 2.9 | An HR of >1 is considered to mean that asenapine has a higher likelihood of being a CGI-I Responder than placebo | Superiority or Other (legacy) |
| Model uses efficacy FAS population (number of participants: placebo - 100, asenapine 2.5 mg - 96, asenapine - 104) | MMRM | Model included terms of (pooled) site, treatment, visit, baseline, and the interaction of visit by treatment and baseline by visit | 0.017 | Difference in LS Means | 4.2 | 2-Sided | 95 | 0.8 | 7.6 | Estimate is asenapine versus placebo | Superiority or Other (legacy) |
| ANCOVA |
Model included terms of (pooled) site, treatment, and baseline |
| 0.064 |
| Difference in LS Means |
| 2.1 |
| 2-Sided |
| 95 |
| -0.1 |
| 4.3 |
Estimate is asenapine versus placebo |
| Superiority or Other (legacy) |
| ANCOVA |
Model included terms of (pooled) site, treatment, and baseline |
| 0.111 |
| Difference in LS Means |
| 0.19 |
| 2-Sided |
| 95 |
| -0.04 |
| 0.42 |
Estimate is asenapine versus placebo |
| Superiority or Other (legacy) |