40 Week Trial to Study the Safety of Asenapine When Added to Lithium or Valproate in the Treatment of Bipolar Disorder (A7501009)(P05786)
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 Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||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|
- Number of Participants Who Experienced an Adverse Event [ Time Frame: up to 52 weeks ] [ Designated as safety issue: Yes ]Participants who experienced treatment-emergent adverse events, defined as adverse events reported on or after the first dose of study medication in the 12-week lead-in study through the last dose of study drug + 7 days (or + 30 days for serious adverse events).
- Number of Participants Who Discontinued Because of an Adverse Event [ Time Frame: 40 weeks ] [ Designated as safety issue: Yes ]Participants who discontinued study medication due to adverse events.
- Change From Baseline to Week 52 on the Young-Mania Rating Scale (Y-MRS) Score [ Time Frame: Baseline and 52 Weeks ] [ Designated as safety issue: No ]The Y-MRS is an 11-item, clinician-rated instrument used for assessing the symptoms of mania. Y-MRS total score range = 0-60; higher scores indicate greater severity of symptoms.
- Change From Baseline to Week 52 on the Montgomery Asberg Depression Rating Scale (MADRS) Score [ Time Frame: Baseline and 52 Weeks ] [ Designated as safety issue: No ]The MADRS is a 10-item clinician-rated scale for assessing the severity of symptoms of depression. MADRS total score range = 0-60; higher scores indicate greater severity of symptoms.
|Study Start Date:||August 2005|
|Study Completion Date:||December 2007|
|Primary Completion Date:||December 2007 (Final data collection date for primary outcome measure)|
Active Comparator: Asenapine
Asenapine 5 or 10 mg twice daily (BID) sublingually for 40 weeks
Other Name: Org 5222
Placebo Comparator: Placebo
Fast-dissolving tablet; twice daily (BID) sublingually for 40 weeks