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| ID | Type | Description | Link |
|---|---|---|---|
| 25544 | |||
| Aphrodite |
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This is an extension study 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 |
|---|---|---|---|
| 1 | Experimental | asenapine |
|
| 2 | Active Comparator | olanzapine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| asenapine | Drug | 5-10 mg sublingually twice daily for 26 weeks |
| |
| olanzapine |
| Measure | Description | Time Frame |
|---|---|---|
| Long-term Change in Negative Symptoms of Schizophrenia Measured by the Negative Symptom Assessment (NSA) Scale | Decrease from baseline in the NSA scores indicates improvement of efficacy. Range NSA total score is 16 [best]-96 [worst]. | Baseline of Protocol 25543 (NCT 00212836) to 365 days (total time for both protocols 25543 & 25544) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Quality of Life Measured by Quality of Life Scale (QLS) | Increase from baseline in the QLS scores indicates improvement of efficacy. Range QLS total score is 0 [worst]-126 [best]. | Baseline of Protocol 25543 (NCT 00212836) to 365 days (total time for both protocols 25543 & 25544) |
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Inclusion Criteria:
inclusion criteria of the 25543 trial (NCT 00212836; P05817) to enter into
this extension trial.
degree of compliance and completed the 25543
trial, and would benefit from continued treatment
according to the investigator.
Exclusion Criteria:
medical condition.
noncompliant in the 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 twice daily (bid) sublingual (SL) |
| FG001 | Olanzapine | 5-20 mg daily (QD) orally (PO) |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Asenapine | 5-10 mg twice daily (bid) sublingual (SL) |
| BG001 | Olanzapine | 5-20 mg daily (QD) orally (PO) |
| 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 | Long-term Change in Negative Symptoms of Schizophrenia Measured by the Negative Symptom Assessment (NSA) Scale | Decrease from baseline in the NSA scores indicates improvement of efficacy. Range NSA total score is 16 [best]-96 [worst]. | Intent-to-treat population | Posted | Least Squares Mean | Standard Error | Units on a Scale | Baseline of Protocol 25543 (NCT 00212836) to 365 days (total time for both protocols 25543 & 25544) |
|
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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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myocardial infarction | Cardiac disorders | MedDRA 10.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Influenza | Infections and infestations | MedDRA 10.1 | 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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| Drug |
5-20 mg by mouth once daily for 26 weeks |
|
| Other |
|
| BG002 |
| Total |
Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Change in Quality of Life Measured by Quality of Life Scale (QLS) | Increase from baseline in the QLS scores indicates improvement of efficacy. Range QLS total score is 0 [worst]-126 [best]. | Intent-to-treat population | Posted | Least Squares Mean | Standard Error | Units on a Scale | Baseline of Protocol 25543 (NCT 00212836) to 365 days (total time for both protocols 25543 & 25544) |
|
|
|
| 9 |
| 134 |
| 19 |
| 134 |
| EG001 | Olanzapine | 6 | 172 | 21 | 172 |
| Nausea | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| Salmonellosis | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA 10.1 | Systematic Assessment |
|
| Fibula fracture | Injury, poisoning and procedural complications | MedDRA 10.1 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 10.1 | Systematic Assessment |
|
| Dementia | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 10.1 | Systematic Assessment |
|
| Nervousness | Psychiatric disorders | MedDRA 10.1 | Systematic Assessment |
|
| Psychotic disorder | Psychiatric disorders | MedDRA 10.1 | Systematic Assessment |
|
| Schizophrenia | Psychiatric disorders | MedDRA 10.1 | Systematic Assessment |
|
| Stress | Psychiatric disorders | MedDRA 10.1 | Systematic Assessment |
|
| Surgery | Surgical and medical procedures | MedDRA 10.1 | Systematic Assessment |
|
| Weight increased | Investigations | MedDRA 10.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
|
| Schizophrenia | Psychiatric disorders | MedDRA 10.1 | Systematic Assessment |
|
Publication/presentation of data may not be made without prior review and comment by the Sponsor; all reasonable comments of Sponsor will be incorporated as far as the scientific data content is not impaired. A complete copy shall be provided to the Sponsor at least 60 days prior to date of submission. Participation in the Study involves a commitment to publish data from the study in a cooperative publication prior to publication/presentation or on an individual basis.
| D006571 | Heterocyclic Compounds |