At a glance
ClinicalIndex Comparison Record- ✓Meet DSM-IV criteria for cocaine dependence and concurrent bipolar disorder
- ✕Schizophrenia, schizoaffective disorder, or other non-bipolar psychotic disorder
- ✕Unipolar major depression or primary anxiety disorder
- ✕Mental retardation or signs of impaired cognitive functioning
- ✕Dependence on substances other than cocaine, alcohol, cannabis, nicotine, or caffeine
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Valproate Efficacy in Cocaine-Bipolar Comorbidity
In Brief
A Phase 2 clinical trial evaluating Valproate, Placebo, and 1 other intervention for Bipolar Disorder and Cocaine Dependence. Completed, enrolled 152 participants across 2 sites.
Detailed Summary
This proposal will test the efficacy of a promising pharmacological approach for the treatment of comorbid cocaine dependence and bipolar disorder. We propose a randomized, double blind, placebo controlled 12-week trial to test the efficacy of Divalproex sodium (Valproate) plus treatment as usual compared to placebo plus treatment as usual in decreasing cocaine use and stabilizing mood symptoms among patients with comorbid cocaine dependence and bipolar disorder. Treatment as usual includes the use of lithium carbonate for mood stabilization plus supportive psychosocial treatment.
Study Details
Timeline
Interventions
Valproate with dose titration to achieve blood levels within the therapeutic range
Control arm
All participants were started and stabilized on lithium carbonate as a standard treatment for bipolar disorder