At a glance
ClinicalIndex Comparison Record- ✓Documented diagnosis of schizophrenia (paranoid, disorganized, catatonic, residual, or undifferentiated subtype) with persistent negative symptoms
- ✓Clinically stable with no increase in level of psychiatric care in past few months due to symptom worsening
- ✓Caregiver must be available
- ✕Uncontrolled, unstable, or clinically significant medical condition
- ✕Any primary psychiatric disorder other than schizophrenia, including depression
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multicenter, Double-Blind, Flexible -Dose, 6-Month Trial Comparing the Efficacy and Safety of Asenapine With Olanzapine in Stable Subjects With Predominant, Persistent Negative Symptoms of Schizophrenia.
In Brief
A Phase 3 clinical trial evaluating Asenapine and Olanzapine for Schizophrenia. Completed, enrolled 468 participants.
Detailed 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.
Study Details
Timeline
Interventions
5-10 mg sublingually twice daily for up to 26 weeks
5-20 mg by mouth once daily for up to 26 weeks