Frye 2005.
Trial name or title | An evaluation of divalproex versus olanzapine for alcohol abuse relapse prevention in patients with bipolar disorder |
Methods | Randomised single‐blind trial |
Participants | Inclusion criteria: age 18 to 65 years; meeting DSM‐IV criteria for manic episode based on the SCID; meeting DSM‐IV criteria for alcohol dependence or abuse based on the SCID; negative urine pregnancy test Exclusion criteria: inability to give informed consent; liver function tests greater than three times upper limit of normal; history of adverse reaction to divalproex sodium or olanzapine; history of seizure; history of major head trauma; history of hypertension, neurological illness, active hepatitis, hepatic encephalopathy, pancreatitis; not practising a reliable form of birth control |
Interventions | (1) Divalproex sodium; (2) olanzapine Dose: divalproex sodium up to 2500 mg/d; olanzapine up to 20 mg/d Duration: 46 weeks. Country of origin: USA |
Outcomes | Primary outcome: alcohol abuse relapse Secondary outcomes: number of drinking days, percentage of drinking days per month, standard drinks per drinking occasion, craving (assessed through the TLFB method); major mood relapse and adjunctive medication (assessed by prospective life charting) |
Starting date | September 2005 |
Contact information | Frye Mark A, UCLA Neuropsychiatric Institute, Los Angeles, California, United States 90095 |
Notes | Study completed |