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OpenTrials
Completed

NCT Number: NCT00208195

Depakote ER Therapy for Mania Comorbid With Substance Abuse

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.

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Key information

Conditions

Bipolar Disorder Bipolar and Related Disorders Chemically-Induced Disorders Mania Mental Disorders Mood Disorders Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Substance Abuse Substance Dependence Substance-Related Disorders

Age range

19 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Creighton University Psychiatry Research Center

Omaha, Nebraska, 68131, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Divalproex ER

Drug

Primary outcomes

  1. 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 outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Creighton University

Other

Collaborators

  • Abbott

Registry information

Important dates

Study start
2004
Study completion
2007
First posted
Sep 21, 2005
Registry last updated
Dec 14, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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