Tolliver 2009.
| Trial name or title | A double‐blind, placebo‐controlled trial of lamotrigine in individuals with bipolar disorder and co‐morbid alcohol dependence |
| Methods | Randomised placebo‐controlled double‐blind trial |
| Participants | 60 participants Inclusion criteria: age 18 to 65; meeting DSM‐IV‐TR criteria for alcohol dependence with active alcohol use in the past 30 days; meeting DSM‐IV‐TR criteria for bipolar I or bipolar II disorder; average alcohol consumption of at least 35 drinks/wk for men, 28 drinks/wk for women in the last four weeks of active drinking before enrolment; able to provide informed consent and to function at an intellectual level sufficient to allow accurate completion of assessment instruments; currently under the care of a psychiatrist; currently taking a therapeutic dosage of one or more mood‐stabilising medications; stable psychiatric symptoms; agreeing to identify collateral individuals for contact to facilitate follow‐up appointments Exclusion criteria: primary psychiatric diagnosis other than bipolar disorder; any uncontrolled neurological condition; any history of Stevens‐Johnson syndrome or other severe rash requiring hospitalisation; any history of head injury with loss of consciousness; any history of learning disability, alcoholic dementia or electroconvulsive therapy in the past three months; any uncontrolled medical condition; plasma levels of liver transaminases (AST, ALT) greater than three times normal range; concomitant use of valproic acid, carbamazepine, oxcarbazepine, phenytoin, primidone, phenobarbital, disulfiram, naltrexone, acamprosate, topiramate, benzodiazepines or any other medications not allowed per the protocol; women of child‐bearing potential who are pregnant or lactating or who refuse adequate forms of contraception; current suicidal or homicidal risk; baseline scores greater than 35 on the Montgomery‐Asberg Depression Rating Scale or greater than 16 on the Young Mania Rating Scale |
| Interventions | (1) Lamotrigine; (2) placebo Dose: lamotrigine 200 mg/d Duration: 12 weeks. Country of origin: USA |
| Outcomes | Primary outcome: percentage of days of abstinence from alcohol. Secondary outcomes: drinks per week, drinking days per week, heavy drinking days per week; biomarkers of alcohol use; depression; mania/hypomania symptoms; neurocognitive performance |
| Starting date | February 2010 |
| Contact information | Bryan K Tolliver, MD, PhD (843) 792‐5215 tollive@musc.edu; Delisa G Brown (843) 792‐0572, browndg@musc.edu, Clinical Neuroscience Division, Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina Recruiting Charleston, South Carolina, United States 29425 |
| Notes |
ALT: Alanine aminotransferase.
ASI: Addiction Severity Index.
AST: Aspartate aminotransferase.
CIWA‐Ar: Clinical Institute Withdrawal Assessment for Alcohol scale, Revised.
DSM‐IV: Diagnostic and Statistic Manual of Mental Disorders (American Psychiatric Association), Fourth Edition.
GGT: γ‐Glutamyltransferase.
HARS: Hamilton Anxiety Rating Scale.
HDRS: Hamilton Depression Rating Scale.
OCDS: Obsessive‐Compulsive Drinking Scale.
PTSD: Post‐traumatic stress disorder.
SCID: Structured Clinical Interview for DSM.
SCL90‐R: Symptom Checklist‐90 Revised.
TLFB: Timeline follow‐back.