12 Week Study of the Safety/Efficacy of Asenapine When Added to Lithium/Valproate in the Treatment of Bipolar Disorder (A7501008)(COMPLETED)(P05844)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00145470
Recruitment Status : Completed
First Posted : September 5, 2005
Last Update Posted : April 22, 2015
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief 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.

Condition or disease Intervention/treatment Phase
Bipolar Disorder Drug: Asenapine Drug: placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 324 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : June 2005
Actual Primary Completion Date : February 2007
Actual Study Completion Date : March 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bipolar Disorder
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
Asenapine (Org 5222)
Drug: Asenapine
Asenapine fast dissolving tablets 5 and 10 mg; starting dose 5 mg BID 1 day; 10 mg BID after Day 1
Other Name: Org 5222
Placebo Comparator: 2
Drug: placebo
Placebo fast dissolving tablets BID

Primary Outcome Measures :
  1. Improvement in bipolar I disorder manic or mixed symptoms as measured by the Young Mania Rating Scale (YMRS). [ Time Frame: after three weeks of treatment ]

Secondary Outcome Measures :
  1. Safety and tolerability (including extrapyramidal symptoms) of asenapine when used as an adjunct to Lithium or Valproate [ Time Frame: 12 weeks (end of trial) ]
  2. Evaluation of the treatment effects of asenapine compared to placebo with respect to clinical impression of severity of, and improvement in, mania, depression, and overall bipolar state. [ Time Frame: 12 weeks (end of trial) ]
  3. Improvement in symptoms of depression, psychosis, anxiety, cognition and suicidal thinking. [ Time Frame: 12 weeks (end of trial) ]
  4. Evaluation of readiness to discharge and quality of life [ Time Frame: 12 weeks (end of trial) ]

Information from the National Library of Medicine

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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
  • Treated with lithium or valproic acid

Exclusion Criteria:

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

Publications of Results:
Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00145470     History of Changes
Other Study ID Numbers: P05844
First Posted: September 5, 2005    Key Record Dates
Last Update Posted: April 22, 2015
Last Verified: April 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