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

This study has been completed.
Sponsor:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00060905
First received: May 15, 2003
Last updated: August 2, 2006
Last verified: August 2006
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00060905     History of Changes
Other Study ID Numbers: M02-540
Study First Received: May 15, 2003
Last Updated: August 2, 2006
Health Authority: United States: Food and Drug Administration

Keywords provided by Abbott:
Bipolar Disorder (manic or mixed type)

Additional relevant MeSH terms:
Disease
Bipolar Disorder
Pathologic Processes
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Valproic Acid
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
GABA Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs

ClinicalTrials.gov processed this record on September 18, 2014