An Inpatient Study of the Effectiveness and Safety of Depakote ER in the Treatment of Mania/Bipolar Disorder - Full Text View

Purpose

The purpose of this study is to determine the safety and effectiveness of Depakote ER compared to placebo in the treatment of bipolar disorder, manic or mixed type in adults.

Condition	Intervention	Phase
Bipolar Disorder	Drug: Divalproex Sodium (Depakote ER)	Phase III

MedlinePlus related topics:

Bipolar Disorder

Drug Information available for:

Divalproex sodium Valproate Sodium Valproic acid

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Official Title:	An Inpatient Study of the Effectiveness and Safety of Depakote ER in the Treatment of Mania/Bipolar Disorder

Further study details as provided by Abbott:

Primary Outcome Measures:

Change from baseline to the final evaluation for the MRS from the SADS-C for the intent-to-treat dataset.

Secondary Outcome Measures:

Change from baseline to the final evaluation for the Manic Syndrome Scale (MSS), Behavior and Ideation Scale (BIS),
BPRS (and published subscales), Global Assessment Scale (GAS), the Nursing Observation Scale for Inpatient Evaluation (NOSIE), and Burden Questionnaire, as well as the percentage of subjects with at least 50% improvement on the MRS.

Estimated Enrollment:	370
Study Start Date:	January 2003

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

INCLUSION CRITERIA

Current primary diagnosis of bipolar I disorder, mania or mixed type
Acute exacerbation of mania associated with bipolar disorder as defined by Mania Rating Scale score >= 18
Hospitalized no more than 7 days at time of Screening or in process of being admitted
History of at least one prior manic or mixed episode within past 3 years, exclusive of the current episode. Prior manic or mixed episode must be separated from current episode by at least 2 months of sustained improvement

EXCLUSION CRITERIA

History of schizophrenia or schizoaffective disorder
Axis I (e.g., anxiety disorder), or Axis II (e.g., personality disorder) that would interfere with compliance or confound interpretation of study results
Current manic or mixed episode is drug-induced or secondary to a medical disorder (e.g., AIDS, corticosteroids)
Current manic or mixed episode is believed to be caused by antidepressant use (i.e., antidepressant-induced mania)
Had first manic episode after age 60
Has ever taken clozapine
Has received depot neuroleptic medication within one inter-injection interval of first dose of study drug
Urine toxicology screen is positive for phencyclidine (PCP), opiates, cocaine or amphetamines
History of active alcohol or substance dependence within past 3 months.
History of failed treatment on adequate valproate therapy for bipolar disorder
Has taken Depakote (DR or ER) regularly over the last 30 days
Has serious violent, homicidal, or suicidal ideation

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00060905

Locations


United States, California
	Comprehensive Neuroscience of SCA
	Cerritos, California, United States, 90703
	AVI Clinical Research
	Torrance, California, United States, 90505

United States, District of Columbia
	Washington Hospital Center
	Washington, District of Columbia, United States, 20010

United States, Illinois
	Mark Lerman, MD
	Hoffman Estates, Illinois, United States, 60194

United States, Kentucky
	University of Louisville Bipolar Research Program
	Louisville, Kentucky, United States, 40202

United States, Louisiana
	Brentwood Research Inst.
	Shreveport, Louisiana, United States, 71101

United States, Maryland
	Centers for Behavioral Health, LLC
	Rockville, Maryland, United States, 20850

United States, Massachusetts
	McLean Hospital
	Belmont, Massachusetts, United States, 02478

United States, Michigan
	Pioneer Research
	Baltimore, Michigan, United States, 48047

United States, Mississippi
	University of Mississippi Medical Center
	Jackson, Mississippi, United States, 39216

United States, New Jersey
	Steven A. Glass, MD
	Clementon, New Jersey, United States, 08021

United States, New York
	The Holliswood Hospital
	Holliswood, New York, United States, 11423
	NYU School of Medicine – Bellevue
	New York, New York, United States, 10016

United States, Ohio
	MetroHealth Medical Center
	Cleveland, Ohio, United States, 44109

United States, Texas
	UT Mental Sciences Institute
	Houston, Texas, United States, 77030
	San Antonio State Hospital
	San Antonio, Texas, United States, 78223

United States, Virginia
	CNS of Northern Virginia
	Falls Church, Virginia, United States, 22041

United States, Wisconsin
	VAMC
	MIlwaukee, Wisconsin, United States, 53295

Sponsors and Collaborators

Abbott

Investigators


Study Director:	Global Medical Information - Abbott	Abbott

More Information

Publications indexed to this study:

Bowden CL, Swann AC, Calabrese JR, Rubenfaer LM, Wozniak PJ, Collins MA, Abi-Saab W, Saltarelli M; Depakote ER Mania Study Group. A randomized, placebo-controlled, multicenter study of divalproex sodium extended release in the treatment of acute mania. J Clin Psychiatry. 2006 Oct;67(10):1501-10.

Study ID Numbers:	M02-540
First Received:	May 15, 2003
Last Updated:	August 2, 2006
ClinicalTrials.gov Identifier:	NCT00060905
Health Authority:	United States: Food and Drug Administration

Keywords provided by Abbott:

Bipolar Disorder (manic or mixed type)

Study placed in the following topic categories:

Affective Disorders, Psychotic

Mental Disorders

Bipolar Disorder

Mood Disorders

Psychotic Disorders

Valproic Acid

Additional relevant MeSH terms:

Neurotransmitter Agents

Disease

Tranquilizing Agents

Molecular Mechanisms of Pharmacological Action

Physiological Effects of Drugs

Psychotropic Drugs

Central Nervous System Depressants

Enzyme Inhibitors

Antimanic Agents

Pharmacologic Actions

Pathologic Processes

Therapeutic Uses

GABA Agents

Central Nervous System Agents

Anticonvulsants

ClinicalTrials.gov processed this record on November 30, 2008

Sponsored by:	Abbott
Information provided by:	Abbott
ClinicalTrials.gov Identifier:	NCT00060905