Pharmacological Intervention Project (Fluoxetine)

Completed · Phase 2 · Has a placebo group

Conditions studied: Alcoholism, Depression

In brief

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.

Key facts

Study ID

NCT00027378

Run by

University of Pittsburgh

People needed

50

Starts

2001-07-01

Expected to finish

2008-06-01

Last updated by the study team

2013-07-18

Who can join

Age: 15 and older, up to 20. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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.

Where it is running

• Western Psychiatric Institute and Clinic — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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