Efficacy and Safety of Asenapine Compared With Olanzapine in Patients With Persistent Negative Symptoms of Schizophrenia (A7501013)(COMPLETED)(P05771)
Summary
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.
Timeline
- Start
- 2004-12
- Primary completion
- 2008-11
- Completion
- 2008-12
Outcome
Missed primary endpoint
registry analysis (unspecified test); Asenapine vs Olanzapine; p = 0.7177; Mixed Model for Repeated Measurements NCT00145496 ↗
paper Asenapine was not superior to olanzapine in change in the 16-item Negative Symptom Assessment Scale total score in either core study PMID 22198451 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Asenapine | Other / unclassified | 5 mg | Other |
| Subject | Asenapine | Other / unclassified | 10 mg | Other |
| Comparator | Olanzapine | Small molecule | 5 mg | Oral |
| Comparator | Olanzapine | Small molecule | 20 mg | Oral |