Efficacy and Safety of Asenapine With Placebo and Olanzapine (41022)(P05947)
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 1 asenapine 5-10mg BID |
Drug: asenapine
Asenapine 5-10mgBID
|
| Placebo Comparator: 2 Placebo |
Drug: Placebo
Matched against asenapine and olanzapine
|
| Active Comparator: 3 olanzapine 10-20 mg QD |
Drug: Olanzapine
10-20 mg QD
|
Outcome Measures
Primary Outcome Measures
- Change in total Positive and Negative Syndrome Scale (PANSS) score at endpoint (6-week double-blind or last assessment after baseline) from baseline [Screen, baseline, days 4, 7, 14, 21, 28, 35, 42]
A 30-item, clinician rated instrument for assessing the symptoms of schizophrenia. Ratings for each item could range from 1 (absent) to 7 (extreme).
Secondary Outcome Measures
- Changes in PANSS subscale and Marder factor score Clinical Global Impression-Severity of Illness (CGI-S) scores [Screen, baseline, Days 4,7,14,21,28,35,42]
This was not a prespecified key secondary outcome
- Clinical Global Impression Improvement (CGI-I) scores [Days 4,7,14,21,28,35,42]
This was not a prespecified key secondary outcome
- Neurocognition and cognitive functioning [Baseline , day 42]
This was not a prespecified key secondary outcome
- Anxiety [Baseline, day 42]
This was not a prespecified key secondary outcome
- Suicidal thinking [Baseline, day 42]
This was not a prespecified key secondary outcome
- Quality of life and patient functionality [Baseline, day 42]
This was not a prespecified key secondary outcome
- Readiness to discharge, at scheduled assessments and endpoint from baseline [Baseline up to day 14]
This was not a prespecified key secondary outcome
- Extrapyramidal symptoms [Baseline, Days 4,7,14,21,28,35,42]
This was not a prespecified key secondary outcome
- Laboratory parameters [Baseline, Days 14,,28,,42]
This was not a prespecified key secondary outcome
- Vital signs [Baseline, Days ,14,21,28,42]
This was not a prespecified key secondary outcome
- Weight [Baseline, Days 14,,28,,42]
This was not a prespecified key secondary outcome
- Electrocardiograms (ECGs) [Baseline, Days ,14, 28, 42]
This was not a prespecified key secondary outcome
- Adverse events (including serious adverse events) [Screen, baseline, Days 4,7,14,21,28,35,42 and recorded continuously for AEs up to 7 days after endpoint]
This was not a prespecified key secondary outcome
- Serious adverse events (SAEs) up to 30 days after endpoint [Screen, baseline, Days 4,7,14,21,28,35,42 and recorded continuously for AEs up to 30 days after endpoint]
This was not a prespecified key secondary outcome
Eligibility Criteria
Criteria
Inclusion Criteria:
- Currently suffering from an acute exacerbation of schizophrenia.
Exclusion Criteria:
- Have an uncontrolled, unstable medical condition. Have any other psychiatric disorder other than schizophrenia as a primary diagnosis.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Organon and Co
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- P05947
- Hera
- 41022