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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.
Sponsor:
Information provided by:
Schering-Plough
ClinicalTrials.gov Identifier:
NCT00145470
First received: September 1, 2005
Last updated: October 2, 2009
Last verified: October 2009
History of Changes
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:

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

Further study details as provided by Schering-Plough:

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 ] [ Designated as safety issue: No ]

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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • Improvement in symptoms of depression, psychosis, anxiety, cognition and suicidal thinking. [ Time Frame: 12 weeks (end of trial) ] [ Designated as safety issue: No ]
  • Evaluation of readiness to discharge and quality of life [ Time Frame: 12 weeks (end of trial) ] [ Designated as safety issue: No ]

Enrollment: 324
Study Start Date: May 2005
Study Completion Date: April 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
Placebo
 Drug: placebo
Placebo fast dissolving tablets BID

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough
ClinicalTrials.gov Identifier: NCT00145470     History of Changes
Other Study ID Numbers: A7501008, P05844
Study First Received: September 1, 2005
Last Updated: October 2, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Bipolar Disorder
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Asenapine
Antipsychotic Agents
Tranquilizing Agents
 Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on May 16, 2013