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

Sponsored by:	Organon
Information provided by:	Organon
ClinicalTrials.gov Identifier:	NCT00145470

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 III

MedlinePlus related topics: Bipolar Disorder

Drug Information available for: Divalproex sodium Valproate Sodium Valproic acid Lithium carbonate Lithium citrate Org 5222

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Organon:

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
1: Experimental 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
2: Placebo Comparator 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

Responsible Party:	NV Organon, part of Schering-Plough Corporation ( Study Director )
Study ID Numbers:	A7501008
Study First Received:	September 1, 2005
Last Updated:	August 25, 2008
ClinicalTrials.gov Identifier:	NCT00145470
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Affective Disorders, Psychotic
Mental Disorders
Bipolar Disorder
Mood Disorders

Lithium Carbonate
Psychotic Disorders
Valproic Acid
Lithium

Additional relevant MeSH terms:

Pathologic Processes
Disease

ClinicalTrials.gov processed this record on January 16, 2009