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

August 2, 2006 updated by: Abbott
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

370

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Cerritos, California, United States, 90703
        • Comprehensive Neuroscience of SCA
      • Torrance, California, United States, 90505
        • AVI Clinical Research
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Washington Hospital Center
    • Illinois
      • Hoffman Estates, Illinois, United States, 60194
        • Mark Lerman, MD
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • University of Louisville Bipolar Research Program
    • Louisiana
      • Shreveport, Louisiana, United States, 71101
        • Brentwood Research Inst.
    • Maryland
      • Rockville, Maryland, United States, 20850
        • Centers for Behavioral Health, LLC
    • Massachusetts
      • Belmont, Massachusetts, United States, 02478
        • McLean Hospital
    • Michigan
      • Baltimore, Michigan, United States, 48047
        • Pioneer Research
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • University of Mississippi Medical Center
    • New Jersey
      • Clementon, New Jersey, United States, 08021
        • Steven A. Glass, MD
    • New York
      • Holliswood, New York, United States, 11423
        • The Holliswood Hospital
      • New York, New York, United States, 10016
        • NYU School of Medicine - Bellevue
    • Ohio
      • Cleveland, Ohio, United States, 44109
        • MetroHealth Medical Center
    • Texas
      • Houston, Texas, United States, 77030
        • UT Mental Sciences Institute
      • San Antonio, Texas, United States, 78223
        • San Antonio State Hospital
    • Virginia
      • Falls Church, Virginia, United States, 22041
        • CNS of Northern Virginia
    • Wisconsin
      • MIlwaukee, Wisconsin, United States, 53295
        • VAMC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott

Investigators

  • Study Director: Global Medical Information - Abbott, Abbott

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2003

Study Registration Dates

First Submitted

May 15, 2003

First Submitted That Met QC Criteria

May 15, 2003

First Posted (Estimate)

May 16, 2003

Study Record Updates

Last Update Posted (Estimate)

August 4, 2006

Last Update Submitted That Met QC Criteria

August 2, 2006

Last Verified

August 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M02-540

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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