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

This study has been completed.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp. Identifier:
First received: September 1, 2005
Last updated: January 7, 2015
Last verified: January 2015
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.

Condition Intervention Phase
Bipolar Disorder
Drug: Asenapine
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, 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

Resource links provided by NLM:

Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Number of Participants Who Experienced an Adverse Event [ Time Frame: 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 [ Time Frame: 40 weeks ]
    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 ]
    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 ]
    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.

Enrollment: 77
Study Start Date: August 2005
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Asenapine
Drug: Asenapine
Asenapine 5 or 10 mg twice daily (BID) sublingually for 40 weeks
Other Name: Org 5222
Placebo Comparator: Placebo
Drug: Placebo
Fast-dissolving tablet; twice daily (BID) sublingually for 40 weeks


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
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No Contacts or Locations Provided
  More Information

Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00145509     History of Changes
Other Study ID Numbers: P05786
Study First Received: September 1, 2005
Results First Received: March 26, 2010
Last Updated: January 7, 2015

Additional relevant MeSH terms:
Bipolar Disorder
Bipolar and Related Disorders
Mental Disorders
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs processed this record on May 22, 2017