40 Week Trial to Study the Safety of Asenapine When Added to Lithium or Valproate in the Treatment of Bipolar Disorder (A7501009)(P05786)

Phase 3

Completed

• Conditions: Bipolar Disorder
• Interventions: Drug: Asenapine; Drug: Placebo

• Registration Number: NCT00145509
• Lead Sponsor: Organon and Co

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-08
• Study First Submitted: 2005-09-01
• Study First Submitted QC: 2005-09-02
• Study First Posted: 2005-09-05
• Primary Completion: 2007-12
• Study Completion: 2007-12
• Disposition First Submitted: 2009-04-23
• Disposition First Submitted QC: 2009-10-02
• Disposition First Posted: 2009-10-06
• Results First Submitted: 2010-03-26
• Results First Submitted QC: 2010-03-26
• Results First Posted: 2010-04-16
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-04
• Last Update Posted: 2022-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 77

Inclusion Criteria

• Have bipolar I disorder (current episode manic or mixed), be treated with lithium or valproic acid, and have completed the a 12-week lead-in trial

Exclusion Criteria

• Have an unstable medical condition or clinically significant laboratory abnormality.
• Have a primary diagnosis other than bipolar I disorder.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Asenapine	Asenapine	Asenapine
Placebo	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Experienced an Adverse Event	up to 52 weeks	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	40 weeks	Participants who discontinued study medication due to adverse events.
Change From Baseline to Week 52 on the Montgomery Asberg Depression Rating Scale (MADRS) Score	Baseline and 52 Weeks	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.
Change From Baseline to Week 52 on the Young-Mania Rating Scale (Y-MRS) Score	Baseline and 52 Weeks	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.