Alcoholism Clinical Trial
Official title:
A Phase 2, Double-Blind, Placebo Controlled Trial to Assess the Efficacy of Quetiapine Fumarate Extended Release for the Treatment of Alcohol Dependence in Very Heavy Drinkers.
The purpose of this study is to determine whether quetiapine fumarate extended release is effective in the treatment of alcohol dependence in very heavy drinkers.
This study will investigate quetiapine fumarate XR (SEROQUEL XR®), a dibenzothiazepine
derivative, as a potential medication for treating alcohol dependence. The immediate release
form of quetiapine fumarate, SEROQUEL XR®, is approved by the FDA for treatment of
schizophrenia and acute manic episodes associated with bipolar disorder. The extended release
formulation (SEROQUEL XR®) is also approved by the FDA and is undergoing clinical
investigation for the treatment of major depressive disorders, schizophrenia, generalized
anxiety disorder, and alcohol dependence.
Treatment with other atypical antipsychotics such as clozapine and olanzapine has resulted in
decreases in alcohol use in alcohol dependent patients with and without comorbid psychiatric
diagnoses. Quetiapine, like clozapine, appears to have efficacy in reducing drug and alcohol
use among alcoholics and drug dependent patients with co-morbid psychiatric illness.
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