Depakote ER Therapy for Mania Comorbid With Substance Abuse

December 12, 2007 updated by: Creighton University
The purpose of this study is to ascertain whether Depakote ER (Divalproex ER) has efficacy in the treatment of patients with bipolar disorder in the manic phase, who also have comorbid substance abuse diagnoses. It is proposed that Depakote ER will decrease scores on the Young Mania Rating Scale and the Substance Abuse Time Line Follow Back.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study will be performed in male and female subjects with a diagnosis of bipolar disorder in the manic phase of the illness who also have a comorbid diagnosis of substance abuse. This population is selected so the efficacy of Depakote ER in this population can be tested.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 4

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
    • Nebraska
      • Omaha, Nebraska, United States, 68131
        • Creighton University Psychiatry Research Center

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

19 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Ages 19 - 65.
  2. Diagnosis of mania with comorbid substance confirmed by Structured Clinical Interview for DSM-IV.
  3. Comorbid diagnoses of anxiety and/or personality disorders are permitted.
  4. Ability to provide signed informed consent.
  5. Stable general medical health.
  6. Ability to attend outpatient research clinic.

Exclusion Criteria:

  1. Dangerous to self or others.
  2. Pregnancy, inability or unwillingness to use approved methods of birth control.
  3. Inability or unwillingness to provide signed informed consent.
  4. Diagnosis of schizophrenia, major depressive disorder.
  5. Inability to attend outpatient research clinic.
  6. Medical conditions, which would preclude use of Depakote.
  7. Need for ongoing treatment with medication other than Depakote ER, such as antipsychotic medication.
  8. Medical instability defined as likelihood of needing to change prescription medication during the course of the study.

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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The primary outcome measures will consist of the total score on the YMRS, and the number of days abstinent from substances of abuse with the TLFB.
Time Frame: Patients will be evaluated on a weekly basis for the first month, then every 2 weeks for the next 2 months, then monthly for the next 3 months for a total study duration of 6 months
Patients will be evaluated on a weekly basis for the first month, then every 2 weeks for the next 2 months, then monthly for the next 3 months for a total study duration of 6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
The Addiction Severity Index (ASI), Penn Alcohol Craving Scale, and Clinical Global Impression (CGI).
Time Frame: Patients will be evaluated on a weekly basis for the first month, then every 2 weeks for the next 2 months, then monthly for the next 3 months, for a total study duration of 6 months
Patients will be evaluated on a weekly basis for the first month, then every 2 weeks for the next 2 months, then monthly for the next 3 months, for a total study duration of 6 months

Collaborators and Investigators

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

Sponsor

Creighton University

Collaborators

Abbott

Investigators

  • Principal Investigator: Pirzada Sattar, MD, Creighton University

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

March 1, 2004

Study Completion (Actual)

November 1, 2007

Study Registration Dates

First Submitted

September 14, 2005

First Submitted That Met QC Criteria

September 14, 2005

First Posted (Estimate)

September 21, 2005

Study Record Updates

Last Update Posted (Estimate)

December 14, 2007

Last Update Submitted That Met QC Criteria

December 12, 2007

Last Verified

December 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 03-13258

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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