At a glance
ClinicalIndex Comparison Record- ✓Must have completed asenapine 3-week and 9-week studies for treatment of acute manic or mixed episode
- ✓No major protocol violations in prior asenapine studies
- ✕Unstable medical conditions
- ✕Clinically significant laboratory abnormalities
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Double-Blind, 40-Week Continuation Study Evaluating the Safety of Asenapine and Olanzapine in the Treatment of Subjects With Acute Mania Clinical Trial Protocol A7501007 (Secondary Title: ARES)
In Brief
A Phase 3 clinical trial evaluating asenapine and Olanzapine for Bipolar Disorder. Completed, enrolled 218 participants.
Detailed Summary
Bipolar disorder is characterized by mood swings that range from from high (manic) to low (depressed) states. Sometimes, symptoms of both depression and mania are present (mixed episodes). Asenapine is an investigational medication for the treatment of manic or mixed episodes of bipolar disorder. Patients who completed study A7501006 (a 9 week extension study) could continue with the same treatment that they had been receiving: asenapine or olanzapine (a medication that is already approved for the treatment of bipolar mania) in a 40 -week continuation study.
Study Details
Timeline
Interventions
Asenapine, 40 weeks
Olanzapine, 40 weeks