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| ID | Type | Description | Link |
|---|---|---|---|
| 25520 |
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The primary features of schizophrenia and schizoaffective disorder are positive (inability to think clearly and distinguish reality from fantasy) and negative symptoms (reduction or absence of normal behavior or emotions). Other symptoms include reduced ability to recall and learn information, difficulty in problem solving maintaining productive employment.
Asenapine is an investigational drug that may help to correct the above schizophrenia by altering the inbalance of brain hormones such as dopamine serotonin. This is a long-term extension trial to further test the efficacy and safety asenapine and a comparator agent (olanzapine) in the treatment of patients with schizophrenia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental |
| |
| Arm 2 | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| asenapine | Drug | Flexible dose, 1-2 tablets sublingual two times per day (1 or 2 tablets in the morning and 1 or 2 tablets in the evening). Each tablet contains either 5 mg asenapine or matching placebo. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in total PANSS score at endpoint | Screening, Week 76, 100, and once every 24 weeks thereafter until endpoint |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in PANSS subscale scores and Marder factor scores | Every 24 weeks after baseline | |
| Changes in CGI-S | Every 12 weeks after baseline | |
| Patient functionality and subjective well-being (as measured by LOF, SF-12 and SWN) |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22454251 | Result | Schoemaker J, Stet L, Vrijland P, Naber D, Panagides J, Emsley R. Long-term efficacy and safety of asenapine or olanzapine in patients with schizophrenia or schizoaffective disorder: an extension study. Pharmacopsychiatry. 2012 Jul;45(5):196-203. doi: 10.1055/s-0031-1301310. Epub 2012 Mar 27. |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D011618 | Psychotic Disorders |
| 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 | Flexible dose, 1-2 capsules oral once per day (in the morning). Each capsule contains 10 mg olanzapine or matching placebo. |
|
|
| Every 48 weeks after baseline |
| Severity of depressed mood (as measured by the Calgary Depression Scale for Schizophrenia) | Every 24 weeks after baseline |
| Resource utilization (as measured by frequency and length of hospital stay) | During the entire study period |
| Safety and tolerability: EPS (AIMS, BARS, SARS) | Every 24 weeks after baseline |
| Adverse Events | Continuously and up to 7 days after endpoint |
| Pregnancy Test | At endpoint |
| Blood Tests | Every 12 weeks after baseline |
| Weight and vital signs | Every 4 weeks after baseline |
| ECGs | Every 24 weeks after baseline |
| D006571 | Heterocyclic Compounds |