Ostacher 2007.

Trial name or title	Adjunctive topiramate for treatment of alcohol dependence in patients with bipolar disorder
Methods	Randomised placebo‐controlled double‐blind trial
Participants	80 participants Inclusion criteria: age 18 years and older; meeting DSM‐IV criteria for alcohol dependence; meeting DSM‐IV criteria for bipolar disorder; ≥ eight heavy drinking days (defined as ≥ five standard drinks per day for men, ≥ four standard drinks per day for women) in the prior four weeks; receiving a stable dose of accepted maintenance treatment for bipolar disorder for the past four weeks; If participant is taking more than one agent, at least one agent must be adequately dosed; antidepressant treatment is permitted if the dose has been stable for the past four weeks Exclusion criteria: pregnant women or women of child‐bearing potential who are not using a medically accepted means of contraception; women who are lactating; important alcohol withdrawal symptoms; urine toxicological screen positive for amphetamines or cocaine; meeting DSM‐IV criteria for current substance dependence other than cannabis or nicotine; meeting current full DSM‐IV criteria for manic, hypomanic or mixed episode; serious suicide or homicide risk; unstable medical illness, including cardiovascular, hepatic, renal, respiratory, endocrine, neurological or haematological disease or uncontrolled seizure disorder; history of nephrolithiasis or treatment with any drug associated with nephrolithiasis; current treatment with zonisamide; current treatment with any carbonic anhydrase inhibitors; current treatment with any drug known to decrease drinking; individuals who have begun a new psychosocial treatment within 12 weeks of study enrolment; any psychotic disorder, including schizoaffective disorder (current or past); clinical or laboratory evidence of untreated hypothyroidism; diagnosis or history of glaucoma; past intolerance to topiramate; any use of topiramate in the past 12 months; any investigational psychotropic drug within the last three months
Interventions	(1) Topiramate; (2) placebo Dose: topiramate 300 mg/d Duration: 12 weeks. Country of origin: USA
Outcomes	Primary outcome: amount of alcohol consumed Secondary outcomes: safety and tolerability of topiramate; effect of decreased drinking on mood symptoms
Starting date	August 2007
Contact information	Michael J. Ostacher, MD, MPH, 617‐726‐5258, mostacher@partners.org ; Andrew Peckham, 617‐724‐6545, apeckham@partners.org, Massachusetts General Hospital Bipolar Clinic and Research Program, Boston, Massachusetts, United States 02114
Notes