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Depakote ER Therapy for Mania Comorbid With Substance Abuse

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00208195
First Posted: September 21, 2005
Last Update Posted: December 14, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Abbott
Information provided by:
Creighton University
  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
Intervention Model: Single Group Assignment
Masking: None (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 ]

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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Syed Pirzada Sattar, M.D., Creighton University
ClinicalTrials.gov Identifier: NCT00208195     History of Changes
Other Study ID Numbers: 03-13258
First Submitted: September 14, 2005
First Posted: September 21, 2005
Last Update Posted: December 14, 2007
Last Verified: December 2007

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

Additional relevant MeSH terms:
Bipolar Disorder
Substance-Related Disorders
Bipolar and Related Disorders
Mental Disorders
Chemically-Induced Disorders
Valproic Acid
Anticonvulsants
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