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

Bipolar Disorder Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00145509
• Other study ID #: P05786
• Secondary ID: A7501009
• Status: Completed
• Phase: Phase 3
• Start date: August 2005
• Est. completion date: December 2007

Study information

• Verified date: February 2022
• Source: Organon and Co
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bipolar Disorder

Intervention

Drug:
• Asenapine
Asenapine 5 or 10 mg twice daily (BID) sublingually for 40 weeks
• Placebo
Fast-dissolving tablet; twice daily (BID) sublingually for 40 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Organon and Co

References & Publications (1)

Szegedi A, Calabrese JR, Stet L, Mackle M, Zhao J, Panagides J; Apollo Study Group. Asenapine as adjunctive treatment for acute mania associated with bipolar disorder: results of a 12-week core study and 40-week extension. J Clin Psychopharmacol. 2012 Feb — View Citation

Outcome

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