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

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

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

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

Resource links provided by NLM:

MedlinePlus related topics: Bipolar Disorder

Drug Information available for: Divalproex sodium Valproic acid Valproate Sodium

U.S. FDA Resources

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

No publications provided by Abbott

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

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
Study First Received:	May 15, 2003
Last Updated:	August 2, 2006
ClinicalTrials.gov Identifier:	NCT00060905 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Abbott:

Bipolar Disorder (manic or mixed type)

Additional relevant MeSH terms:

Neurotransmitter Agents
Disease
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
Bipolar Disorder
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants
Enzyme Inhibitors
Antimanic Agents

Valproic Acid
Pharmacologic Actions
Affective Disorders, Psychotic
Pathologic Processes
Mental Disorders
Therapeutic Uses
Mood Disorders
GABA Agents
Central Nervous System Agents
Anticonvulsants

ClinicalTrials.gov processed this record on November 25, 2009