40 Week Trial to Study the Safety of Asenapine When Added to Lithium or Valproate in the Treatment of Bipolar Disorder (A7501009)(COMPLETED) - Full Text View

Sponsored by:	Organon
Information provided by:	Organon
ClinicalTrials.gov Identifier:	NCT00145509

Purpose

This is a 40-week extension study that will test the long term safety and efficacy of asenapine when used in addition to lithium or valproate for subjects with Bipolar I Disorder who have completed study A7501008.

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, Non-Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Phase 3, Placebo-Controlled, Double-Blinded Continuation Trial Evaluating the Safety and Efficacy of Asenapine in Subjects Completing Trial A7501008 and 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:

Characterize long-term safety and tolerability of asenapine in bipolar I disorder subjects [ Time Frame: 40 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Longterm maintenance of effect on the Young -Mania rating scale (Y-MRS) and Montgomery-Asberg Depression Rating Scale (MADRS) scores (in the A7501008 lead-in trial) with adjunctive therapy. [ Time Frame: After the initial 12 weeks of treatment ] [ Designated as safety issue: No ]
Long-term adjunctive 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: At various time points during the 40 week trial ] [ Designated as safety issue: Yes ]
Improvement in symptoms of depression, psychosis, anxiety, cognition and suicidal thinking. [ Time Frame: At various time points during the 40 week trial ] [ Designated as safety issue: No ]
Evaluation of readiness to discharge and quality of life. [ Time Frame: At various time points during the 40 week trial ] [ Designated as safety issue: No ]

Enrollment:	176
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
Arm 1: Active Comparator Asenapine	Drug: Asenapine Asenapine 5 or 10 mg BID SubL
Arm 2: Placebo Comparator Placebo	Drug: Placebo Fast-dissolving tablet; SL BID, 40 weeks

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), be treated with lithium or valproic acid, and have completed A7501008

Exclusion Criteria:

Have an unstable medical condition or 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:	A7501009
Study First Received:	September 1, 2005
Last Updated:	August 8, 2008
ClinicalTrials.gov Identifier:	NCT00145509
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