Depakote ER Therapy for Mania Comorbid With Substance Abuse

Phase 4CompletedNCT00208195

Creighton University20 enrolled

Overview

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.

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

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Bipolar Disorder Mania Substance Abuse Substance Dependence

Interventions

Divalproex ERDRUG

Eligibility

Sex: ALLMin age: 19 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Creighton University Psychiatry Research Center

Omaha, Nebraska, United States

Outcomes

Primary Outcomes

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

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

Data from ClinicalTrials.gov

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