Skip to main content
. 2014 Feb 13;2014(2):CD008544. doi: 10.1002/14651858.CD008544.pub2

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