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| ID | Type | Description | Link |
|---|---|---|---|
| Aphrodite | |||
| A7501013 |
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Treatment with conventional antipsychotics such as haloperidol has little effect or may sometimes even worsen negative symptoms (such as blunted affect, emotional withdrawal, and poor rapport) of schizophrenia. The newer "atypical" antipsychotics agents, such as olanzapine, has shown improvement in the treatment of negative symptoms in acute trials. The purpose of this study is to compare an investigational compound (asenapine) with a marketed agent (olanzapine) in the treatment of stable subjects with persistent negative symptoms of schizophrenia for 6 months. Patients completing this study may be eligible to participate in an extension 6 months of treatment. Patients are required to have stable symptoms prior to entry into study.
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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 up to 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 to 96, with greater scores indicating greater severity of symptoms. | Day 182 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Quality of Life Measured by the Quality of Life Scale (QLS) Total Score | The Quality of Life Scale 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 to 126, with greater values indicating better quality of life. | Day 182 |
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Inclusion Criteria:
Exclusion Criteria:
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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 up to 26 weeks |
| FG001 | Olanzapine | 5-20 mg by mouth once daily for up to 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 up to 26 weeks |
| BG001 | Olanzapine | 5-20 mg by mouth once daily for up to 26 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 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 to 96, with greater scores indicating greater severity of symptoms. | Analysis was intent to treat - subjects who received at least 1 dose of double-blind trial medication and had at least 1 post-baseline value. | Posted | Mean | Standard Error | Units on a Scale | Day 182 |
|
Adverse events (AEs) were recorded at each visit through end of treatment in this protocol (6 months). For subjects who did not continue in an extension protocol, serious adverse events (SAEs) were recorded via telephone 30 days after end of treatment.
Information regarding AEs was obtained by questioning or examining the
subject at each visit, and recording complaints and symptoms.
Reports are for all SAEs and treatment-emergent nonserious AEs.
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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 up to 26 weeks |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| PANCYTOPENIA | Blood and lymphatic system disorders | MedDRA (11.1) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| DRY MOUTH | Gastrointestinal disorders | MedDRA (11.1) | 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 up to 26 weeks |
|
| Change From Baseline in Body Weight | Day 182 |
| Withdrawal by Subject |
|
| Lost to Follow-up |
|
| Other |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Age, Customized | Number | participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Body Weight | Mean | Standard Deviation | kg |
|
5-20 mg by mouth once daily for up to 26 weeks
|
|
|
| Secondary | Change From Baseline in Quality of Life Measured by the Quality of Life Scale (QLS) Total Score | The Quality of Life Scale 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 to 126, with greater values indicating better quality of life. | Analysis was intent to treat - subjects who received at least 1 dose of double-blind trial medication and had at least 1 post-baseline value. | Posted | Mean | Standard Error | Units on a Scale | Day 182 |
|
|
|
|
| Secondary | Change From Baseline in Body Weight | Analysis was intent to treat - subjects who received at least 1 dose of double-blind trial medication and had at least 1 post-baseline value. | Posted | Mean | Standard Error | kg | Day 182 |
|
|
|
|
| 30 |
| 244 |
| 145 |
| 244 |
| EG001 | Olanzapine | 5-20 mg by mouth once daily for up to 26 weeks | 18 | 224 | 140 | 224 |
| ATRIAL FIBRILLATION | Endocrine disorders | MedDRA (11.1) | Systematic Assessment |
|
| VENTRICULAR EXTRASYSTOLES | General disorders | MedDRA (11.1) | Systematic Assessment |
|
| PYREXIA | General disorders | MedDRA (11.1) | Systematic Assessment |
|
| CHOLECYSTITIS CHRONIC | Hepatobiliary disorders | MedDRA (11.1) | Systematic Assessment |
|
| CHOLELITHIASIS | Hepatobiliary disorders | MedDRA (11.1) | Systematic Assessment |
|
| PORCELAIN GALLBLADDER | Hepatobiliary disorders | MedDRA (11.1) | Systematic Assessment |
|
| BRONCHITIS | Infections and infestations | MedDRA (11.1) | Systematic Assessment |
|
| CELLULITIS | Infections and infestations | MedDRA (11.1) | Systematic Assessment |
|
| CLOSTRIDIUM DIFFICILE COLITIS | Infections and infestations | MedDRA (11.1) | Systematic Assessment |
|
| DIABETES MELLITUS INADEQUATE CONTROL | Metabolism and nutrition disorders | MedDRA (11.1) | Systematic Assessment |
|
| GRAND MAL CONVULSION | Nervous system disorders | MedDRA (11.1) | Systematic Assessment |
|
| HEMORRHAGIC STROKE | Nervous system disorders | MedDRA (11.1) | Systematic Assessment |
|
| ALCOHOL ABUSE | Psychiatric disorders | MedDRA (11.1) | Systematic Assessment |
|
| HOMICIDAL IDEATION | Psychiatric disorders | MedDRA (11.1) | Systematic Assessment |
|
| PSYCHOTIC DISORDER | Psychiatric disorders | MedDRA (11.1) | Systematic Assessment |
|
| SCHIZOPHRENIA | Psychiatric disorders | MedDRA (11.1) | Systematic Assessment |
|
| SCHIZOPHRENIA, PARANOID TYPE | Psychiatric disorders | MedDRA (11.1) | Systematic Assessment |
|
| SCHIZOPHRENIA, UNDIFFERENTIATED TYPE | Psychiatric disorders | MedDRA (11.1) | Systematic Assessment |
|
| SUICIDAL IDEATION | Psychiatric disorders | MedDRA (11.1) | Systematic Assessment |
|
| ASTHMA | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | Systematic Assessment |
|
| CHRONIC OBSTRUCTIVE PULMONARY DISEASE | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | Systematic Assessment |
|
| NAUSEA | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
|
| WEIGHT INCREASED | Investigations | MedDRA (11.1) | Systematic Assessment |
|
| INCREASED APPETITE | Metabolism and nutrition disorders | MedDRA (11.1) | Systematic Assessment |
|
| AKATHISIA | Nervous system disorders | MedDRA (11.1) | Systematic Assessment |
|
| DIZZINESS | Nervous system disorders | MedDRA (11.1) | Systematic Assessment |
|
| HEADACHE | Nervous system disorders | MedDRA (11.1) | Systematic Assessment |
|
| SEDATION | Nervous system disorders | MedDRA (11.1) | Systematic Assessment |
|
| SOMNOLENCE | Nervous system disorders | MedDRA (11.1) | Systematic Assessment |
|
| ANXIETY | Psychiatric disorders | MedDRA (11.1) | Systematic Assessment |
|
| INSOMNIA | Psychiatric disorders | MedDRA (11.1) | 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 |