| Methods |
Randomised double‐blind placebo‐controlled parallel‐group trial |
| Participants |
Estimated Enrollment: 180
Age: 18 ‐ 65 years
Inclusion Criteria:
DSM‐IV‐TR primary diagnosis of Bipolar I Disorder as confirmed by the SCID Outpatient receiving treatment with a combination of Depakote plus olanzapine for their bipolar illness and considered clinically stable (e.g., no more than minimal symptoms, no psychiatric hospitalizations, no increase in intensity of clinical interventions) for the preceding 4 months Identified at Screening a most bothersome side effect listed in the UKU which makes switching to monotherapy desirable MRS total score < 12 on two consecutive ratings, separated by at least 5 days (Screening and Day 1) DSS score < 13 on two consecutive ratings, separated by at least five days (Screening and Day 1) CGI‐S score < 3 on two consecutive ratings, separated by at least five days (Screening and Day 1) Serum valproate level > 45 mcg/mL, and a maximum allowable dose of Depakote of 3000 mg/day at Screening Olanzapine dose between 5 and 20 mg/day at screening
|
| Interventions |
Depakote (divalproex sodium) plus olanzapine, vs. Depakote monotherapy and olanzapine monotherapy in stable subjects during the maintenance phase of bipolar illness |
| Outcomes |
Primary Outcome Measures: CGI‐s, CGI‐i, MRS, DSS, SADS‐C |
| Notes |
Status of trial on ClinicalTrials.gov = terminated
We are seeking more information regarding this trial. |
