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| ID | Type | Description | Link |
|---|---|---|---|
| Aphrodite | |||
| A7501014 |
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This is an extension study of A7501013 (P05771/NCT00145496) to further test
the efficacy and safety of Asenapine compared with a
marketed agent (olanzapine) in the treatment of patients with
persistent negative symptoms of schizophrenia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| asenapine | Experimental |
| |
| olanzapine | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| asenapine | Drug | 5-10 mg sublingually twice daily for 26 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Negative Symptoms of Schizophrenia Measured by the Negative Symptom Assessment (NSA) Scale Total Score | The NSA Scale is a 16-item clinician-rated instrument for rating the negative symptomatology of schizophrenia. Total score ranges from 16 (best) to 96 (worst), with greater scores indicating greater severity of symptoms. | Baseline of A7501013 to Day 365 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Quality of Life Measured by the Quality of Life Scale (QLS) Total Score | The QLS is a 21-item clinician-rated scale for rating psychosocial functioning (Interpersonal Relations, Instrumental Role, Intrapsychic Foundations, and Common Objects and Activities). The score ranges from 0 (worst) to 126 (best), with greater values indicating better quality of life. | Baseline of A7501013 to Day 365 |
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Inclusion Criteria:
inclusion criteria of the A7501013 trial to enter into
this extension trial.
and completed the A7501013 trial, and would benefit
from continued treatment according to the investigator.
Exclusion Criteria:
medical condition.
management of their disease.
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22198451 | Result | Buchanan RW, Panagides J, Zhao J, Phiri P, den Hollander W, Ha X, Kouassi A, Alphs L, Schooler N, Szegedi A, Cazorla P. Asenapine versus olanzapine in people with persistent negative symptoms of schizophrenia. J Clin Psychopharmacol. 2012 Feb;32(1):36-45. doi: 10.1097/JCP.0b013e31823f880a. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Asenapine | 5-10 mg sublingually twice daily for 26 weeks |
| FG001 | Olanzapine | 5-20 mg by mouth once daily for 26 weeks |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Asenapine | 5-10 mg sublingually twice daily for 26 weeks |
| BG001 | Olanzapine | 5-20 mg by mouth once daily for 26 weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 Negative Symptoms of Schizophrenia Measured by the Negative Symptom Assessment (NSA) Scale Total Score | The NSA Scale is a 16-item clinician-rated instrument for rating the negative symptomatology of schizophrenia. Total score ranges from 16 (best) to 96 (worst), with greater scores indicating greater severity of symptoms. | Intent-to-treat (ITT) population. In-treatment change from baseline scores by visit and baseline scores from the ITT population are included in the Mixed Model for Repeated Measurements (MMRM) model. | Posted | Least Squares Mean | Standard Error | Units on a Scale | Baseline of A7501013 to Day 365 |
|
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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 | 5-10 mg sublingually twice daily for 26 weeks |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastritis | Gastrointestinal disorders | 12.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | 12.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C522667 | asenapine |
| D000077152 | Olanzapine |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| olanzapine |
| Drug |
5-20 mg by mouth once daily for 26 weeks |
|
|
| Withdrawal by Subject |
|
| Lost to Follow-up |
|
| Other (Not specified) |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
5-20 mg by mouth once daily for 26 weeks |
|
|
|
| Secondary | Change From Baseline in Quality of Life Measured by the Quality of Life Scale (QLS) Total Score | The QLS is a 21-item clinician-rated scale for rating psychosocial functioning (Interpersonal Relations, Instrumental Role, Intrapsychic Foundations, and Common Objects and Activities). The score ranges from 0 (worst) to 126 (best), with greater values indicating better quality of life. | ITT population. In-treatment change from baseline scores by visit and baseline scores from the ITT population are included in the MMRM model. | Posted | Least Squares Mean | Standard Error | Units on a Scale | Baseline of A7501013 to Day 365 |
|
|
|
|
| 4 |
| 85 |
| 14 |
| 85 |
| EG001 | Olanzapine | 5-20 mg by mouth once daily for 26 weeks | 4 | 110 | 31 | 110 |
| Hyponatraemia | Metabolism and nutrition disorders | 12.0 | Systematic Assessment |
|
| Alcohol Abuse | Psychiatric disorders | 12.0 | Systematic Assessment |
|
| Psychotic Disorder | Psychiatric disorders | 12.0 | Systematic Assessment |
|
| Schizophrenia | Psychiatric disorders | 12.0 | Systematic Assessment |
|
| Schizophrenia, Paranoid Type | Psychiatric disorders | 12.0 | Systematic Assessment |
|
| Weight Increased | Investigations | 12.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | 12.0 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | 12.0 | Systematic Assessment |
|
Except for compelling legal reasons, neither the sponsor nor the investigator will communicate to third parties any result of the clinical trial before the clinical trial report has been released by the sponsor.
| D006571 | Heterocyclic Compounds |