Depakote ER Therapy for Mania Comorbid With Substance Abuse

This study has been completed.
Sponsor:
Collaborator:
Abbott
Information provided by:
Creighton University
ClinicalTrials.gov Identifier:
NCT00208195
First received: September 14, 2005
Last updated: December 12, 2007
Last verified: December 2007
  Purpose

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.


Condition Intervention Phase
Bipolar Disorder
Mania
Substance Abuse
Substance Dependence
Drug: Divalproex ER
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Depakote ER Therapy for Mania Comorbid With Substance Abuse

Resource links provided by NLM:


Further study details as provided by Creighton University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: March 2004
Study Completion Date: November 2007
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.

  Eligibility

Ages Eligible for Study:   19 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  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: NCT00208195

Locations
United States, Nebraska
Creighton University Psychiatry Research Center
Omaha, Nebraska, United States, 68131
Sponsors and Collaborators
Creighton University
Abbott
Investigators
Principal Investigator: Pirzada Sattar, MD Creighton University
  More Information

No publications provided

Responsible Party: Syed Pirzada Sattar, M.D., Creighton University
ClinicalTrials.gov Identifier: NCT00208195     History of Changes
Other Study ID Numbers: 03-13258
Study First Received: September 14, 2005
Last Updated: December 12, 2007
Health Authority: United States: Institutional Review Board

Keywords provided by Creighton University:
Bipolar Disorder
Mania
Substance Abuse
Substance Dependence
Comorbid

Additional relevant MeSH terms:
Bipolar Disorder
Substance-Related Disorders
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Chemically-Induced 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 August 28, 2014