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

This study has been completed.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp. Identifier:
First received: September 1, 2005
Last updated: April 21, 2015
Last verified: April 2015
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 Intervention Phase
Bipolar Disorder Drug: Asenapine Drug: placebo Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

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

Primary Outcome Measures:
  • 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:
  • Safety and tolerability (including extrapyramidal symptoms) of asenapine when used as an adjunct to Lithium or Valproate [ Time Frame: 12 weeks (end of trial) ]
  • 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) ]
  • Improvement in symptoms of depression, psychosis, anxiety, cognition and suicidal thinking. [ Time Frame: 12 weeks (end of trial) ]
  • Evaluation of readiness to discharge and quality of life [ Time Frame: 12 weeks (end of trial) ]

Enrollment: 324
Study Start Date: June 2005
Study Completion Date: March 2007
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00145470     History of Changes
Other Study ID Numbers: P05844
Study First Received: September 1, 2005
Last Updated: April 21, 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 August 23, 2017