drugset / Trial / NCT00212836
Efficacy and Safety of Asenapine Compared With Olanzapine in Patients With Persistent Negative Symptoms of Schizophrenia (25543)(COMPLETED)(P05817)
RandomizedParallel-groupQuadruple-blindTreatment
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, have 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
- 2005-04-21
- Primary completion
- 2007-06-15
- Completion
- 2007-08-02
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 |