At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 326 enrolled
Drug / intervention
Asenapine +1 moredrug
Likely dose
Asenapine 5-10 mg sublingually twice dailyAI-extracted
Key inclusion· 2
- ✓Diagnosis of bipolar I disorder with current manic or mixed episode
- ✓Currently treated with lithium or valproic acid/divalproex sodium
Key exclusion· 3
- ✕Unstable medical condition
- ✕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, Randomized, Placebo-Controlled, Double-Blinded Trial Evaluating the Safety and Efficacy of Asenapine in Subjects 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 326 participants.
Detailed Summary
This is a 12-week study that will test the safety and efficacy of asenapine when used in addition to lithium or valproate for subjects with acute manic or mixed episodes of Bipolar I Disorder.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBipolar Disorder
Countries--
Collaborators--
Timeline
Phase 3CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJun 2005
First PostedSep 2005
Primary CompletionFeb 2007
Study CompletionMar 2007
TodayJul 2026
First PostedSep 5, 2005
Enrollment StartJun 2, 2005
Primary CompletionFeb 28, 2007
Study CompletionMar 22, 2007
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 20.8 years ago
Interventions
Asenapinedrug
Asenapine fast dissolving SL tablets 5 and 10 mg; starting dose 5 mg BID on Day 1; 5-10 mg BID after Day 1.
Placebodrug
Placebo fast dissolving SL tablets, BID