Divalproex ER vs. Risperidone for Bipolar Disorder With Comorbid Substance Use Disorder
The primary objective is to evaluate the safety and efficacy of divalproex extended release (ER) compared to risperidone in the treatment of bipolar disorder with comorbid substance use disorder
Drug: divalproex sodium ER
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Primary Purpose: Treatment
|Official Title:||Divalproex ER vs. Risperidone for Bipolar Disorder With Comorbid Substance Use Disorder|
- The primary objective is to evaluate the safety and efficacy of divalproex extended release (ER) compared to risperidone in the treatment of bipolar disorder with comorbid substance use disorder.
|Study Start Date:||January 2004|
|Study Completion Date:||February 2007|
Patients will be screened up to seven days at which time the following assessments will be completed: the Structured Clinical Interview for DSM-IV (SCID), general medical history, psychiatric history, physical examination, physicians assessment, and laboratory tests. Patients who are on mood stabilizers and oral neuroleptics prior to study enrollment and are not responding fully to these medications will be tapered off of the medication for a washout period of 48 hours. After the completion of screening, only patients who are determined to be eligible for the study will be randomized to study medication (divalproex or risperidone) in a 1:1 double-blind fashion. Scheduled study visits will occur every two weeks for a total of 12 weeks. Assessments for each visit, from the baseline visit to the week 12 visit are as follows: the Clinical Global Impression (CGI), Global Assessment of Functioning (GAF), Alcohol and Drug Use Inventory, clinician alcohol and drug use scales, self report scales, adverse events, vital signs and weight, concomitant medications, urine drug screen, and study medication accountability. Designated research staff will complete assessments weekly. Investigators will be blinded to laboratory tests completed at week 2, 4, and 12 visits. Patients randomized to Depakote ER will begin 500mg BID on day of randomization and remain on this dose for 5 days, then on day 6 increase to 20mg/kg to achieve valproic acid levels of 80-100 (blinded laboratory reporting). Patients randomized to risperidone, initially start with 2mg QD with an increase to 4mg at day 5 and increase (as tolerated or required) up to 6mg/d.
|United States, Alabama|
|Tuscaloosa Research & Education Advancement Corporation|
|Tuscaloosa, Alabama, United States, 35404|
|Principal Investigator:||Lori L Davis, MD||Tuscaloosa VA Medical Center|