Pharmacological Intervention Project (Fluoxetine)

• Status: Completed
• Trial end date: 2008-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a large scale study involving fluoxetine (Prozac) versus a placebo in the treatment of adolescents with alcohol use disorder (AUD) and major depression (MDD). All individuals will receive treatment for 12 weeks with a followup phase lasting 9 months.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Pittsburgh
• Collaborator: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Treatments: Fluoxetine

Criteria

Inclusion Criteria:

• Meets criteria for alcohol use disorder and major depressive disorder.

Exclusion Criteria:

• Meets criteria for bipolar disorder, schizoaffective disorder, or schizophrenia.

• Hyper- or hypothyroidism, significant cardiac, neurologic, or renal impairment, and those with significant liver disease.

• Receiving antipsychotic or antidepressant medication in the month prior to entering the study.

• Use of any illicit substance abuse or dependence other than cannabis abuse (and alcohol abuse).

• History of intravenous drug use.

• Pregnancy, inability or unwillingness to use contraceptive methods.

• Inability to read or understand study forms

• Less than 15 years of age or over 18 years of age will be excluded.