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A multicenter, randomized, parallel-group, double-blind, fixed dose, 6-week trial of the efficacy and safety of asenapine compared with placebo in participants with an acute exacerbation of schizophrenia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Asenapine 5 mg BID | Experimental | Participants received a 5 mg asenapine fast dissolving tablet twice daily (BID) for 6 weeks. |
|
| Asenapine 10 mg BID | Experimental | Participants received a 5 mg asenapine fast dissolving tablet BID on Day 1, then 10 mg asenapine fast dissolving tablet BID thereafter for a total of 6 weeks. |
|
| Placebo BID | Placebo Comparator | Participants received matching placebo BID for 6 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Asenapine 5 mg | Drug | Asenapine 5 mg fast dissolving tablets sublingually without water twice daily, in the morning (around 8 am) and in the evening (around 8 pm), on Day 1 only or for 6 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score. | PANSS total score measures symptoms of schizophrenia and consists of responses to 30 items: 7 items from the positive subscale (P1-P7), 7 items from the negative subscale (N1-N7) and 16 items from the general psychopathology subscale (G1-G16). Responses to each item range from 1 = absence of symptom, to 7 = most extreme symptoms. The PANSS total score is the sum of the scores for all 30 items, and ranges from 30 to 210, with a higher score indicating greater severity of symptoms. Change from baseline values that are negative represent an improvement in symptoms. | Baseline and Day 42 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in PANSS Positive Symptom Score. | PANSS Positive subscale measures symptoms of schizophrenia and consists of responses to 7 items (P1-P7). Responses to each item range from 1 = absence of symptom, to 7 = most extreme symptoms. The PANSS Positive subscale sums all 7 items and ranges from 7 to 49, with a higher score indicating greater severity of symptoms. An improvement in symptoms is represented by change from baseline values that are negative. |
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Inclusion Criteria:
current diagnosis of schizophrenia of paranoid, disorganized, catatonic, or undifferentiated (295.90) subtype
minimum Positive and Negative Syndrome Scale (PANSS) total score of 60 at screening and Baseline.
participant had a score of at least 4 in two or more of 5 items in the positive subscale of the PANSS at Screening and Baseline.
participant confirmed by the investigator to be experiencing an acute exacerbation of schizophrenia as evidenced by ALL of the following:
participant had a Clinical Global Impressions-Severity (CGI-S) scale score of at least 4 (moderately ill) at Baseline;
responded positively to an antipsychotic medication in a prior episode.
discontinued the use of all prohibited concomitant medications, with last dose taken no later than the evening prior to the baseline visit (For depot neuroleptic, discontinuation must have occurred more than 3 months prior to randomization).
participants must agree to inpatient status for screening period and for up to 42 days of dosing and, for out-patient phase, had a caregiver or an identified responsible person (e.g., family member, social worker, case worker, or nurse) whom the investigator accepts and who has agreed to provide support to the participant to ensure compliance with study treatment, out-patient visits, and protocol procedures.
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 |
|---|---|---|---|
| 27271087 | Result | Kinoshita T, Bai YM, Kim JH, Miyake M, Oshima N. Efficacy and safety of asenapine in Asian patients with an acute exacerbation of schizophrenia: a multicentre, randomized, double-blind, 6-week, placebo-controlled study. Psychopharmacology (Berl). 2016 Jul;233(14):2663-74. doi: 10.1007/s00213-016-4295-9. Epub 2016 Jun 8. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Asenapine 5 mg BID | Participants received a 5 mg asenapine fast dissolving tablet twice daily (BID) for 6 weeks. |
| FG001 | Asenapine 10 mg BID | Participants received a 5 mg asenapine fast dissolving tablet BID on Day 1, then 10 mg asenapine fast dissolving tablet BID thereafter for a total of 6 weeks. |
| FG002 | Placebo BID | Participants received matching placebo BID for 6 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Participants who received at least one dose of trial medication.
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| ID | Title | Description |
|---|---|---|
| BG000 | Asenapine 5 mg BID | Participants received a 5 mg asenapine fast dissolving tablet BID for 6 weeks. |
| BG001 | Asenapine 10 mg BID | Participants received a 5 mg asenapine fast dissolving tablet BID on Day 1, then 10 mg asenapine fast dissolving tablet BID thereafter for a total of 6 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| 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. | PANSS total score measures symptoms of schizophrenia and consists of responses to 30 items: 7 items from the positive subscale (P1-P7), 7 items from the negative subscale (N1-N7) and 16 items from the general psychopathology subscale (G1-G16). Responses to each item range from 1 = absence of symptom, to 7 = most extreme symptoms. The PANSS total score is the sum of the scores for all 30 items, and ranges from 30 to 210, with a higher score indicating greater severity of symptoms. Change from baseline values that are negative represent an improvement in symptoms. | All randomized participants who received at least one dose of trial medication, and had baseline and at least one post-baseline PANSS measurement. Dropout or missing data are imputed by the last observation carried forward (LOCF) method. | Posted | Least Squares Mean | 95% Confidence Interval | Score on a scale | Baseline and Day 42 |
|
Up to 49 days for non-serious adverse events (AEs), and up to 79 days for serious AEs
Participants who received at least one dose of trial medication
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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 5 mg BID | Participants received a 5 mg asenapine fast dissolving tablet BID for 6 weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sinus Bradycardia | Cardiac disorders | MedDRA 17.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | 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 |
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|
| Asenapine 10 mg | Drug | Participants receive on Day 2, 10 mg BID of fast dissolving tablets sublingually without water twice daily, in the morning (around 8 am) and in the evening (around 8 pm), for 6 weeks. |
|
|
| Placebo | Drug | A matching placebo of asenapine sublingual tablet not containing asenapine |
|
| Baseline and Day 42 |
| Change From Baseline in PANSS Negative Symptom Score. | PANSS Negative subscale measures symptoms of schizophrenia and consists of responses to 7 items (N1-N7). Responses to each item range from 1 = absence of symptom, to 7 = most extreme symptoms. The PANSS Negative subscale sums all 7 items and ranges from 7 to 49, with a higher score indicating greater severity of symptoms. . An improvement in symptoms is represented by change from baseline values that are negative. | Baseline and Day 42 |
| Change From Baseline in PANSS General Psychopathology Score. | PANSS General Psychopathology subscale measures symptoms of schizophrenia and consists of responses to 16 items (G1-G16). Responses to each item range from 1 = absence of symptom, to 7 = most extreme symptoms. The PANSS General Psychopathology subscale is the sum of the scores for all 16 items and ranges from 16 to 112, with a higher score indicating greater severity of symptoms.. An improvement in symptoms is represented by change from baseline values that are negative. | Baseline and Day 42 |
| Change From Baseline in PANSS Marder Factor Positive Symptom Score. | PANSS Marder Factor Positive symptom score measures symptoms of schizophrenia and consists of responses to 8 items (P1,P3,P5,P6,N7,G1,G9,G12). Responses to each item range from 1 = absence of symptom, to 7 = most extreme symptoms. The PANSS Marder Factor Positive symptom score is the sum of the scores for all 8 items and ranges from 8 to 56, with a higher score indicating greater severity of symptoms. An improvement in symptoms is represented by change from baseline values that are negative. | Baseline and Day 42 |
| Change From Baseline in PANSS Marder Factor Negative Symptom Score. | PANSS Marder Factor Negative symptom score measures symptoms of schizophrenia and consists of responses to 7 items (N1,N2,N3,N4,N6,G7,G16). Responses to each item range from 1 = absence of symptom, to 7 = most extreme symptoms. The PANSS Marder Factor Negative symptom score is the sum of the scores for all 7 items and ranges from 7 to 49, with a higher score indicating greater severity of symptoms. An improvement in symptoms is represented by change from baseline values that are negative. | Baseline and Day 42 |
| Change From Baseline in PANSS Marder Factor Disorganized Thought Symptom Score. | PANSS Marder Factor Disorganized Thought symptom score measures symptoms of schizophrenia and consists of responses to 7 items (P2,N5,G5,G10,G11,G13,G15). Responses to each item range from 1 = absence of symptom, to 7 = most extreme symptoms. The PANSS Marder Factor Disorganized Thought symptom score is the sum of the scores for all 7 items and ranges from 7 to 49, with a higher score indicating greater severity of symptoms. An improvement in symptoms is represented by change from baseline values that are negative. | Baseline and Day 42 |
| Change From Baseline in PANSS Marder Factor Hostility/Excitement Symptom Score. | PANSS Marder Factor Hostility/Excitement symptom score measures symptoms of schizophrenia and consists of responses to 4 items (P4,P7,G8,G14). Responses to each item range from 1 = absence of symptom, to 7 = most extreme symptoms. The PANSS Marder Factor Hostility/Excitement symptom score is the sum of the scores for all 4 items and ranges from 4 to 28, with a higher score indicating greater severity of symptoms. An improvement in symptoms is represented by change from baseline values that are negative. | Baseline and Day 42 |
| Change From Baseline in PANSS Marder Factor Anxiety/Depression Symptom Score. | PANSS Marder Factor Anxiety/Depression symptom score measures symptoms of schizophrenia and consists of responses to 4 items (G2,G3,G4,G6). Responses to each item range from 1 = absence of symptom, to 7 = most extreme symptoms. The PANSS Marder Factor Anxiety/Depression symptom score is the sum of the scores for all 4 items and ranges from 4 to 28, with a higher score indicating greater severity of symptoms. An improvement in symptoms is represented by change from baseline values that are negative. | Baseline and Day 42 |
| Percentage of Participants Who Were PANSS Responders. | PANSS total score measures symptoms of schizophrenia and consists of responses to 30 items: 7 items from the positive subscale (P1-P7), 7 items from the negative subscale (N1-N7) and 16 items from the general psychopathology subscale (G1-G16). Responses to each item range from 1 = absence of symptom, to 7 = most extreme symptoms. The PANSS total score is the sum of the scores for all 30 items, and ranges from 30 to 210, with a higher score indicating greater severity of symptoms. The PANSS total score was determined at baseline and then at Day 42, and a participant with a 30% or greater reduction from baseline in PANSS total score at Day 42 was considered a PANSS responder. | Day 42 |
| Change From Baseline in Clinical Global Impressions -Severity of Illness (CGI-S) Score. | The CGI-S is a score that measures the severity of overall bipolar illness. The score ranges on a scale from 1 to 7, where 1 is normal, and 7 is very severely ill. Change from baseline values that are negative represent an improvement in symptoms. | Baseline and Day 42 |
| Percentage of Participants Who Were Clinical Global Impressions - Improvement (CGI-I) Responders. | The CGI-I is a score on a 7-point scale for assessing the change from preceding phase of overall symptoms of bipolar disorder during the treatment of an acute episode or in longer term illness prophylaxis. Compared to the baseline, the CGI-I score ranges from 1 = very much improved since initiating treatment, to 7 = very much worse since initiating treatment. The CGI-I score was assessed at baseline and Day 42. Compared to the baseline measurement, a CGI-I responder had a score at Day 42 of 3 (minimally improved), 2 (much improved) or 1 (very much improved). | Day 42 |
| Lack of Efficacy |
|
| Other |
|
| Untreated |
|
| BG002 | Placebo BID | Participants received matching placebo BID for 6 weeks. |
| BG003 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Participants received a 5 mg asenapine fast dissolving tablet BID for 6 weeks. |
| OG001 | Asenapine 10 mg BID | Participants received a 5 mg asenapine fast dissolving tablet BID on Day 1, then 10 mg asenapine fast dissolving tablet BID thereafter for a total of 6 weeks. |
| OG002 | Placebo BID | Participants received matching placebo BID for 6 weeks. |
|
|
|
| Secondary | Change From Baseline in PANSS Positive Symptom Score. | PANSS Positive subscale measures symptoms of schizophrenia and consists of responses to 7 items (P1-P7). Responses to each item range from 1 = absence of symptom, to 7 = most extreme symptoms. The PANSS Positive subscale sums all 7 items and ranges from 7 to 49, with a higher score indicating greater severity of symptoms. An improvement in symptoms is represented by change from baseline values that are negative. | All randomized participants who received at least one dose of trial medication, and had baseline and at least one post-baseline PANSS measurement. Dropout or missing data are imputed by the LOCF method. | Posted | Least Squares Mean | 95% Confidence Interval | Score on a scale | Baseline and Day 42 |
|
|
|
|
| Secondary | Change From Baseline in PANSS Negative Symptom Score. | PANSS Negative subscale measures symptoms of schizophrenia and consists of responses to 7 items (N1-N7). Responses to each item range from 1 = absence of symptom, to 7 = most extreme symptoms. The PANSS Negative subscale sums all 7 items and ranges from 7 to 49, with a higher score indicating greater severity of symptoms. . An improvement in symptoms is represented by change from baseline values that are negative. | All randomized participants who received at least one dose of trial medication, and had baseline and at least one post-baseline PANSS measurement. One participant from the 5 mg BID arm was missing a post-baseline measurement. Dropout or missing data are imputed by the LOCF method. | Posted | Least Squares Mean | 95% Confidence Interval | Score on a scale | Baseline and Day 42 |
|
|
|
|
| Secondary | Change From Baseline in PANSS General Psychopathology Score. | PANSS General Psychopathology subscale measures symptoms of schizophrenia and consists of responses to 16 items (G1-G16). Responses to each item range from 1 = absence of symptom, to 7 = most extreme symptoms. The PANSS General Psychopathology subscale is the sum of the scores for all 16 items and ranges from 16 to 112, with a higher score indicating greater severity of symptoms.. An improvement in symptoms is represented by change from baseline values that are negative. | All randomized participants who received at least one dose of trial medication, and had baseline and at least one post-baseline PANSS measurement. Dropout or missing data are imputed by the LOCF method. | Posted | Least Squares Mean | 95% Confidence Interval | Score on a scale | Baseline and Day 42 |
|
|
|
|
| Secondary | Change From Baseline in PANSS Marder Factor Positive Symptom Score. | PANSS Marder Factor Positive symptom score measures symptoms of schizophrenia and consists of responses to 8 items (P1,P3,P5,P6,N7,G1,G9,G12). Responses to each item range from 1 = absence of symptom, to 7 = most extreme symptoms. The PANSS Marder Factor Positive symptom score is the sum of the scores for all 8 items and ranges from 8 to 56, with a higher score indicating greater severity of symptoms. An improvement in symptoms is represented by change from baseline values that are negative. | All randomized participants who received at least one dose of trial medication, and had baseline and at least one post-baseline PANSS measurement. Dropout or missing data are imputed by the LOCF method. | Posted | Least Squares Mean | 95% Confidence Interval | Score on a scale | Baseline and Day 42 |
|
|
|
|
| Secondary | Change From Baseline in PANSS Marder Factor Negative Symptom Score. | PANSS Marder Factor Negative symptom score measures symptoms of schizophrenia and consists of responses to 7 items (N1,N2,N3,N4,N6,G7,G16). Responses to each item range from 1 = absence of symptom, to 7 = most extreme symptoms. The PANSS Marder Factor Negative symptom score is the sum of the scores for all 7 items and ranges from 7 to 49, with a higher score indicating greater severity of symptoms. An improvement in symptoms is represented by change from baseline values that are negative. | All randomized participants who received at least one dose of trial medication, and had baseline and at least one post-baseline PANSS measurement. Dropout or missing data are imputed by the LOCF method. | Posted | Least Squares Mean | 95% Confidence Interval | Score on a scale | Baseline and Day 42 |
|
|
|
|
| Secondary | Change From Baseline in PANSS Marder Factor Disorganized Thought Symptom Score. | PANSS Marder Factor Disorganized Thought symptom score measures symptoms of schizophrenia and consists of responses to 7 items (P2,N5,G5,G10,G11,G13,G15). Responses to each item range from 1 = absence of symptom, to 7 = most extreme symptoms. The PANSS Marder Factor Disorganized Thought symptom score is the sum of the scores for all 7 items and ranges from 7 to 49, with a higher score indicating greater severity of symptoms. An improvement in symptoms is represented by change from baseline values that are negative. | All randomized participants who received at least one dose of trial medication, and had baseline and at least one post-baseline PANSS measurement. One participant from the 5 mg BID arm was missing a post-baseline measurement. Dropout or missing data are imputed by the LOCF method. | Posted | Least Squares Mean | 95% Confidence Interval | Score on a scale | Baseline and Day 42 |
|
|
|
|
| Secondary | Change From Baseline in PANSS Marder Factor Hostility/Excitement Symptom Score. | PANSS Marder Factor Hostility/Excitement symptom score measures symptoms of schizophrenia and consists of responses to 4 items (P4,P7,G8,G14). Responses to each item range from 1 = absence of symptom, to 7 = most extreme symptoms. The PANSS Marder Factor Hostility/Excitement symptom score is the sum of the scores for all 4 items and ranges from 4 to 28, with a higher score indicating greater severity of symptoms. An improvement in symptoms is represented by change from baseline values that are negative. | All randomized participants who received at least one dose of trial medication, and had baseline and at least one post-baseline PANSS measurement. Dropout or missing data are imputed by the LOCF method | Posted | Least Squares Mean | 95% Confidence Interval | Score on a scale | Baseline and Day 42 |
|
|
|
|
| Secondary | Change From Baseline in PANSS Marder Factor Anxiety/Depression Symptom Score. | PANSS Marder Factor Anxiety/Depression symptom score measures symptoms of schizophrenia and consists of responses to 4 items (G2,G3,G4,G6). Responses to each item range from 1 = absence of symptom, to 7 = most extreme symptoms. The PANSS Marder Factor Anxiety/Depression symptom score is the sum of the scores for all 4 items and ranges from 4 to 28, with a higher score indicating greater severity of symptoms. An improvement in symptoms is represented by change from baseline values that are negative. | All randomized participants who received at least one dose of trial medication, and had baseline and at least one post-baseline PANSS measurement. Dropout or missing data are imputed by the LOCF method. | Posted | Least Squares Mean | 95% Confidence Interval | Score on a scale | Baseline and Day 42 |
|
|
|
|
| Secondary | Percentage of Participants Who Were PANSS Responders. | PANSS total score measures symptoms of schizophrenia and consists of responses to 30 items: 7 items from the positive subscale (P1-P7), 7 items from the negative subscale (N1-N7) and 16 items from the general psychopathology subscale (G1-G16). Responses to each item range from 1 = absence of symptom, to 7 = most extreme symptoms. The PANSS total score is the sum of the scores for all 30 items, and ranges from 30 to 210, with a higher score indicating greater severity of symptoms. The PANSS total score was determined at baseline and then at Day 42, and a participant with a 30% or greater reduction from baseline in PANSS total score at Day 42 was considered a PANSS responder. | All randomized participants who received at least one dose of trial medication, and had baseline and at least one post-baseline PANSS measurement. Dropout or missing data are imputed by the LOCF method. | Posted | Number | 95% Confidence Interval | Percentage of participants | Day 42 |
|
|
|
|
| Secondary | Change From Baseline in Clinical Global Impressions -Severity of Illness (CGI-S) Score. | The CGI-S is a score that measures the severity of overall bipolar illness. The score ranges on a scale from 1 to 7, where 1 is normal, and 7 is very severely ill. Change from baseline values that are negative represent an improvement in symptoms. | All randomized participants who received at least one dose of trial medication, and had baseline and at least one post-baseline PANSS measurement. Dropout or missing data are imputed by the LOCF method. | Posted | Least Squares Mean | 95% Confidence Interval | Score on a scale | Baseline and Day 42 |
|
|
|
|
| Secondary | Percentage of Participants Who Were Clinical Global Impressions - Improvement (CGI-I) Responders. | The CGI-I is a score on a 7-point scale for assessing the change from preceding phase of overall symptoms of bipolar disorder during the treatment of an acute episode or in longer term illness prophylaxis. Compared to the baseline, the CGI-I score ranges from 1 = very much improved since initiating treatment, to 7 = very much worse since initiating treatment. The CGI-I score was assessed at baseline and Day 42. Compared to the baseline measurement, a CGI-I responder had a score at Day 42 of 3 (minimally improved), 2 (much improved) or 1 (very much improved). | All randomized participants who received at least one dose of trial medication, and had baseline and at least one post-baseline PANSS measurement. Dropout or missing data are imputed by the LOCF method. | Posted | Number | 95% Confidence Interval | Percentage of participants | Day 42 |
|
|
|
|
| 10 |
| 175 |
| 96 |
| 175 |
| EG001 | Asenapine 10 mg BID | Participants received a 5 mg asenapine fast dissolving tablet BID on Day 1, then 10 mg asenapine fast dissolving tablet BID thereafter for a total of 6 weeks. | 5 | 181 | 110 | 181 |
| EG002 | Placebo BID | Participants received matching placebo BID for 6 weeks. | 13 | 174 | 89 | 174 |
| Vomiting | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 17.0 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 17.0 | Systematic Assessment |
|
| Epilepsy | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
|
| Subarachnoid Hemorrhage | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
|
| Agitation | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
|
| Schizophrenia | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
|
| Schizophrenia, paranoid type | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
|
| Suicide attempt | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Systematic Assessment |
|
| Hypoaesthesia oral | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
|
| Blood creatine phosphokinase increased | Investigations | MedDRA 17.0 | Systematic Assessment |
|
| Akathisia | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
|
| Extrapyramidal disorder | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
|
| Schizophrenia | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
|
The investigator agrees to provide the sponsor 45 days prior to submission for publication or presentation, review copies of abstracts or manuscripts for publication that report any results of the trial. The sponsor shall have the right to review and comment with respect to publications, abstracts, slides, and manuscripts, and to review and comment on the data analysis and presentation.
| ANCOVA |
Change from baseline a response variable, baseline score a covariate. |
| <0.0001 |
| LS mean difference |
| -3.79 |
| Standard Error of the Mean |
| 0.67 |
| 2-Sided |
| 95 |
| -5.11 |
| -2.46 |
Asenapine 10 mg BID minus Placebo BID |
| Superiority or Other (legacy) |
| ANCOVA |
Change from baseline a response variable, baseline score a covariate, treatment groups and regions as explanatory variables. |
| <0.0001 |
| LS mean difference |
| -3.03 |
| Standard Error of the Mean |
| 0.54 |
| 2-Sided |
| 95 |
| -4.08 |
| -1.97 |
Asenapine 10 mg BID minus Placebo BID |
| Superiority or Other (legacy) |
| ANCOVA |
Change from baseline a response variable, baseline score a covariate, treatment groups and regions as explanatory variables. |
| <0.0001 |
Statistical significant: p=<0.05, two sided |
| LS mean difference |
| -6.53 |
| Standard Error of the Mean |
| 1.06 |
| 2-Sided |
| 95 |
| -8.62 |
| -4.44 |
Asenapine 10 mg BID minus Placebo BID |
| Superiority or Other (legacy) |
| ANCOVA |
Change from baseline a response variable, baseline score a covariate, treatment groups and regions as explanatory variables. |
| <0.0001 |
| LS mean difference |
| -3.66 |
| Standard Error of the Mean |
| 0.67 |
| 2-Sided |
| 95 |
| -4.97 |
| -2.35 |
Asenapine 10 mg BID minus Placebo BID |
| Superiority or Other (legacy) |
| ANCOVA |
Change from baseline a response variable, baseline score a covariate. |
| <0.0001 |
| LS mean difference |
| -2.94 |
| Standard Error of the Mean |
| 0.56 |
| 2-Sided |
| 95 |
| -4.03 |
| -1.84 |
Asenapine 10 mg BID minus Placebo BID |
| Superiority or Other (legacy) |
| ANCOVA |
Change from baseline a response variable, baseline score a covariate, treatment groups and regions as explanatory variables. |
| <0.0001 |
| LS mean difference |
| -3.08 |
| Standard Error of the Mean |
| 0.51 |
| 2-Sided |
| 95 |
| -4.09 |
| -2.08 |
Asenapine 10 mg BID minus Placebo BID |
| Superiority or Other (legacy) |
| ANCOVA |
Change from baseline a response variable, baseline score a covariate, treatment groups and regions as explanatory variables. |
| <0.0001 |
| LS mean difference |
| -2.26 |
| Standard Error of the Mean |
| 0.40 |
| 2-Sided |
| 95 |
| -3.04 |
| -1.47 |
Asenapine 10 mg BID minus Placebo BID |
| Superiority or Other (legacy) |
| ANCOVA |
Change from baseline a response variable, baseline score a covariate, treatment groups and regions as explanatory variables. |
| <0.0001 |
| LS mean difference |
| -1.53 |
| Standard Error of the Mean |
| 0.32 |
| 2-Sided |
| 95 |
| -2.16 |
| -0.91 |
Asenapine 10 mg BID minus Placebo BID |
| Superiority or Other (legacy) |
| <0.0001 |
Adjusted for region. |
| Mean Difference (Final Values) |
| 23.1 |
| 2-Sided |
| 95 |
| 13.7 |
| 32.6 |
Asenapine 10 mg BID minus Placebo BID |
| Superiority or Other (legacy) |
| ANCOVA |
Change from baseline a response variable, baseline score a covariate, treatment groups and regions as explanatory variables. |
| <0.0001 |
| LS mean difference |
| -0.59 |
| Standard Error of the Mean |
| 0.12 |
| 2-Sided |
| 95 |
| -0.82 |
| -0.36 |
Asenapine 10 mg BID minus Placebo BID |
| Superiority or Other (legacy) |
| <0.0001 |
Adjusted for region. |
| Mean Difference (Final Values) |
| 28.8 |
| 2-Sided |
| 95 |
| 18.9 |
| 38.8 |
Asenapine 10 mg BID minus Placebo BID |
| Superiority or Other (legacy) |