Bipolar Disorder, Mania, Substance Abuse, Substance Dependence
Conditions
Keywords
Bipolar Disorder, Mania, Substance Abuse, Substance Dependence, Comorbid
Brief summary
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.
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.
Interventions
DRUGDivalproex ER
Sponsors
Abbott
Creighton University
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| 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. | 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
| Measure | Time frame |
|---|---|
| The Addiction Severity Index (ASI), Penn Alcohol Craving Scale, and Clinical Global Impression (CGI). | 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 |
Countries
United States
Outcome results
None listed