Pharmacological Intervention Project (Fluoxetine) (FIDAA)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Jack Cornelius, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00027378
First received: December 4, 2001
Last updated: June 17, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention Phase
Alcoholism
Depression
Drug: fluoxetine (Prozac)
Drug: Placebo plus Treatment As Usual
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Pharmacological Intervention Project (Fluoxetine)

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Alcohol Use Behaviors [ Time Frame: Average number of drinks as recorded on the Timeline Follow-Back (subject-reported) measure daily over the 12-week acute phase. ] [ Designated as safety issue: No ]
    Alcohol use behaviors measured by drinks per week.

  • Depressive Symptoms [ Time Frame: Average score as measured by participant's report on the Beck Depression Inventory (BDI). ] [ Designated as safety issue: No ]
    Beck Depression Inventory (BDI) Scores measured at Weeks 1-4, 6, 8, 10, 12. The BDI is a subject reported measure that has a minimum score of 0 and a maximum score of 63. A better outcome would consist of values near the minimum end of the scale (0) and a worse outcome would consist of values near the maximum end of the scale (63).


Enrollment: 50
Study Start Date: July 2001
Study Completion Date: June 2008
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
fluoxetine plus Treatment As Usual (TAU)
Drug: fluoxetine (Prozac)
fluoxetine plus Treatment As Usual (TAU); 12 weeks acute phase; plus 9 month naturalistic follow up
Placebo Comparator: 2
placebo plus Treatment As Usual (TAU)
Drug: Placebo plus Treatment As Usual
placebo plus Treatment as Usual; 12 weeks acute phase; plus 9 month naturalistic follow up

Detailed Description:

Recently, the first large-scale double-blind, placebo-controlled study of a selective serotonin reuptake inhibitor (SSRI) antidepressant in depressed adolescents was completed (Emslie et al., 1997) That study demonstrated efficacy for fluoxetine in non-AUD adolescents with major depressive disorder (MDD). Our own research group recently completed a first double-blind, placebo-controlled study of fluoxetine in adults with comorbid MDD and alcohol dependence (Cornelius et al., 1997). That study demonstrated efficacy for fluoxetine in decreasing both the depressive symptoms and the alcohol use of adult depressed alcoholics. Our own research group also recently completed a pilot study involving open label fluoxetine in adolescents with comorbid AUD and MDD. That pilot study demonstrated within-group efficacy for fluoxetine for decreasing both the drinking and the depressive symptoms of that population, and suggested that fluoxetine is a safe medication in this population (Cornelius, et al., In Press). However, to date, no double-blind, placebo-controlled study of any selective serotonin re-uptake inhibitors (SSRI) medication has been conducted in adolescents with a comorbid AUD and MDD. In this proposed study, a first large scale prospective double-blind, placebo-controlled study will be undertaken involving the SSRI medication fluoxetine versus placebo in the treatment of adolescents with an alcohol use disorder and major depression (AUD/MDD).

The goals of the study include the following: 1) to compare the efficacy of the SSRI medication fluoxetine plus Treatment As Usual (TAU) to placebo plus TAU for the alcohol use and the depressive symptoms of an adolescent sample (ages 15 to 18) of subjects with comorbid diagnoses of an AUD and MDD; 2) to assess specific predictors of medication response in that study; and to perform a preliminary evaluation of the longer-term efficacy of fluoxetine in these patients, in a 9-month naturalistic follow-up period beyond the 3 month acute phase study. We hypothesize that fluoxetine plus TAU will demonstrate efficacy for decreasing both the drinking and the depressive symptoms of this population.

  Eligibility

Ages Eligible for Study:   15 Years to 20 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00027378

Locations
United States, Pennsylvania
Western Psychiatric Institute and Clinic
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Jack Cornelius, M.D. Western Psychiatric Institute and Clinic Pittsburgh
  More Information

Publications:
Responsible Party: Jack Cornelius, Professor of Psychiatry, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00027378     History of Changes
Other Study ID Numbers: NIAAACOR13370, R01AA015173, R01AA013370, AA-13370
Study First Received: December 4, 2001
Results First Received: February 8, 2012
Last Updated: June 17, 2013
Health Authority: United States: Federal Government

Keywords provided by University of Pittsburgh:
fluoxetine,
adolescents,
alcohol dependence,
major depression
Alcoholism
Major Depression

Additional relevant MeSH terms:
Depression
Depressive Disorder
Alcoholism
Behavioral Symptoms
Mood Disorders
Mental Disorders
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Fluoxetine
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 18, 2014