Drug Treatment for Alcoholics With Bipolar Disorder
Completed
University of Pittsburgh
Phase 2
2000-10-01
The purpose of this study is to test the effectiveness of sodium valproate (Depacon) in
treating individuals with alcohol dependence and comorbid bipolar disorder.
Drug Treatment for Alcoholics With Bipolar Disorder
Completed
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Phase 2
2000-10-01
The purpose of this study is to test the effectiveness of sodium valproate (Depacon) in
treating individuals with alcohol dependence and comorbid bipolar disorder.
This clinical study compares the effectiveness of two anticonvulsants Lamotrigine (Lamictal)
Monotherapy and Gabapentin (Neurontin) in patients with treatment resistant affective
disorders. We initially have found that the response rate to lamotrigine (51%) exceeded that
of gabapentin (28%) or placebo (21%). In this study the placebo phase has been dropped so
that we examine possible clinical and biological factors predictors of response. The drugs
will be given in a randomized order for six weeks each and you will not know when you are on
a given one. There will be a 2-4 week "washout" period between treatments. If you respond
well to one of these treatments, a longer open continuation period will be offered at the end
of this study. This would involve one or both drugs in combination. A variety of rating
scales and brain imaging procedures will also be offered before and during each drug
evaluation. Both lamotrigine and gabapentin are generally well tolerated. A serious
potentially life threatening rash occurs in about 1/500 patients treated with lamotrigine,
however. Common side effects are rash, dizziness, unsteadiness, double vision, blurred
vision, nausea, vomiting, insomnia, sedation, and headache. These side effects are usually
mild, and resolve with continued time on the drug or a decrease in dosage.
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