At a glance
ClinicalIndex Comparison Record- ✓Bipolar I disorder with current manic or mixed episode
- ✓Currently treated with lithium or valproic acid
- ✓Completion of 12-week lead-in trial
- ✕Unstable medical condition or clinically significant laboratory abnormality
- ✕Primary diagnosis other than bipolar I disorder
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 3, Placebo-Controlled, Double-Blinded Continuation Trial Evaluating the Safety and Efficacy of Asenapine in Subjects Completing a 12-week Lead-in Trial and Continuing Lithium or Valproic Acid/Divalproex Sodium for the Treatment of an Acute Manic or Mixed Episode
In Brief
A Phase 3 clinical trial evaluating Asenapine and Placebo for Bipolar Disorder. Completed, enrolled 77 participants.
Detailed Summary
The primary objective of this trial was to characterize the long-term (up to 40 weeks) safety and tolerability of asenapine in bipolar I disorder subjects who had not completely responded to continuing treatment with lithium or valproic acid (VPA) for the treatment of an acute manic or mixed episodes upon enrollment into the 12-week lead-in trial, A7501008 (NCT00145470). The safety comparison was between the group receiving lithium or VPA and placebo against the group receiving lithium or VPA and asenapine, with the caveat that all subjects may have received benzodiazepine and/or antidepressant rescue medication as needed.
Study Details
Timeline
Interventions
Asenapine 5 or 10 mg twice daily (BID) sublingually for 40 weeks
Fast-dissolving tablet; twice daily (BID) sublingually for 40 weeks