Study of the Effectiveness of Quetiapine for the Treatment of Alcohol Dependency

• Percent Heavy Drinking Days [ Time Frame: Weeks 3 - 11 ] [ Designated as safety issue: No ]
  A heavy drinking day is defined as 5 or more drinks for men and 4 or more drinks for women during a 24 hour period.
  
  

• Percent Days Abstinent [ Time Frame: 3-11 ] [ Designated as safety issue: No ]
  
• Drinks Per Drinking Day [ Time Frame: 3-11 ] [ Designated as safety issue: No ]
  
• Drinks Per Day [ Time Frame: 3-11 ] [ Designated as safety issue: No ]
  
• Percent Very Heavy Drinking Day [ Time Frame: 3-11 ] [ Designated as safety issue: No ]
  
• Percent Subjects Abstinent [ Time Frame: 3-11 ] [ Designated as safety issue: No ]
  
• Percent Subjects With no Heavy Drinking Day [ Time Frame: 3-11 ] [ Designated as safety issue: No ]
  
• Drinking Consequences Score [ Time Frame: Weeks 6 and 12 ] [ Designated as safety issue: No ]
  DrInc Score
  
  
• Craving Score [ Time Frame: Week 4, 6, 8, 10, 12 ] [ Designated as safety issue: No ]
  PACS
  
  
• Depression Score [ Time Frame: Week 4, 6, 8, 10, and 12 ] [ Designated as safety issue: No ]
  MADRS
  
  
• Anxiety Score [ Time Frame: Weeks 4, 6, 8, 10 and 12 ] [ Designated as safety issue: No ]
  HAM-A
  
  
• Sleep Quality Score [ Time Frame: Weeks 4, 8 and 12 ] [ Designated as safety issue: No ]
  Pittsburgh Sleep Quality Index
  
  
• Quality of Life Score [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  Quality of Life SF - 12
  
  

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.