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Pharmacological Intervention Project (fluoxetine) - Article


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Fluoxetine

Prozac; Prozac Weekly; Sarafem 




Clinical Trial: Pharmacological Intervention Project (fluoxetine)

This study is currently recruiting patients.

Sponsored by: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by: National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Purpose

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

Condition Treatment or Intervention Phase
Alcoholism
 Drug: fluoxetine (Prozac)
Phase II

MedlinePlus related topics:  Alcoholism

Study Type: Interventional
Study Design: Treatment, Randomized, Placebo Control

Further Study Details: 

Expected Total Enrollment:  106

Expected completion: July 2006

Eligibility

Ages Eligible for Study:  15 Years   -   18 Years,  Genders Eligible for Study:  Both

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.

Location and Contact Information


Pennsylvania
      Western Psychiatric Institute and Clinic, Pittsburgh,  Pennsylvania,  15213,  United States; Recruiting
Dr. Jack Cornelius  412-578-3424 

More Information

Study ID Numbers:  NIAAACOR13370
Record last reviewed:  November 2003
Last Updated:  October 13, 2004
Record first received:  December 4, 2001
ClinicalTrials.gov Identifier:  NCT00027378
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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December 4, 2009



Page Updated: October 1, 2005
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