Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| Hera | |||
| 41022 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Schizophrenia is a brain disease. The primary features of schizophrenia are characterized by Positive symptoms (symptoms that should not be there, inability to think clearly, to distinguish reality from fantasy i.e., hearing voices) and Negative symptoms (a reduction or absence of normal behaviors or emotions, i.e., unable to manage emotions, make decisions and relate to others). Other symptoms include reduced ability to recall and learn new information, difficulty with problem solving, or maintaining productive employment. The symptoms of schizophrenia may be due to an imbalance in chemicals in the brain, primarily dopamine and serotonin, which enables brain cells to communicate with each other.
Asenapine is an investigational drug that may help to correct the imbalance in dopamine and serotonin. This is a 6 week study to test the efficacy and safety of asenapine and a comparator agent (olanzapine) in the treatment of patients with schizophrenia. Patients that complete this trial will have the option of continuing in an additional one year extension trial.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | asenapine 5-10mg BID |
|
| 2 | Placebo Comparator | Placebo |
|
| 3 | Active Comparator | olanzapine 10-20 mg QD |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| asenapine | Drug | Asenapine 5-10mgBID |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Change in total Positive and Negative Syndrome Scale (PANSS) score at endpoint (6-week double-blind or last assessment after baseline) from baseline | A 30-item, clinician rated instrument for assessing the symptoms of schizophrenia. Ratings for each item could range from 1 (absent) to 7 (extreme). | Screen, baseline, days 4, 7, 14, 21, 28, 35, 42 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in PANSS subscale and Marder factor score Clinical Global Impression-Severity of Illness (CGI-S) scores | This was not a prespecified key secondary outcome | Screen, baseline, Days 4,7,14,21,28,35,42 |
| Clinical Global Impression Improvement (CGI-I) scores |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23290326 | Result | Szegedi A, Verweij P, van Duijnhoven W, Mackle M, Cazorla P, Fennema H. Meta-analyses of the efficacy of asenapine for acute schizophrenia: comparisons with placebo and other antipsychotics. J Clin Psychiatry. 2012 Dec;73(12):1533-40. doi: 10.4088/JCP.11r07596. |
Not provided
Not provided
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| C522667 | asenapine |
| D000077152 | Olanzapine |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
Matched against asenapine and olanzapine |
|
| Olanzapine | Drug | 10-20 mg QD |
|
This was not a prespecified key secondary outcome |
| Days 4,7,14,21,28,35,42 |
| Neurocognition and cognitive functioning | This was not a prespecified key secondary outcome | Baseline , day 42 |
| Anxiety | This was not a prespecified key secondary outcome | Baseline, day 42 |
| Suicidal thinking | This was not a prespecified key secondary outcome | Baseline, day 42 |
| Quality of life and patient functionality | This was not a prespecified key secondary outcome | Baseline, day 42 |
| Readiness to discharge, at scheduled assessments and endpoint from baseline | This was not a prespecified key secondary outcome | Baseline up to day 14 |
| Extrapyramidal symptoms | This was not a prespecified key secondary outcome | Baseline, Days 4,7,14,21,28,35,42 |
| Laboratory parameters | This was not a prespecified key secondary outcome | Baseline, Days 14,,28,,42 |
| Vital signs | This was not a prespecified key secondary outcome | Baseline, Days ,14,21,28,42 |
| Weight | This was not a prespecified key secondary outcome | Baseline, Days 14,,28,,42 |
| Electrocardiograms (ECGs) | This was not a prespecified key secondary outcome | Baseline, Days ,14, 28, 42 |
| Adverse events (including serious adverse events) | This was not a prespecified key secondary outcome | Screen, baseline, Days 4,7,14,21,28,35,42 and recorded continuously for AEs up to 7 days after endpoint |
| Serious adverse events (SAEs) up to 30 days after endpoint | This was not a prespecified key secondary outcome | Screen, baseline, Days 4,7,14,21,28,35,42 and recorded continuously for AEs up to 30 days after endpoint |
| D006571 | Heterocyclic Compounds |