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Pharmacological Intervention Project (Fluoxetine) (FIDAA)

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ClinicalTrials.gov Identifier: NCT00027378
Recruitment Status : Completed
First Posted : December 5, 2001
Results First Posted : July 18, 2013
Last Update Posted : July 18, 2013
Sponsor:
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
Jack Cornelius, University of Pittsburgh

Brief 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.

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

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Pharmacological Intervention Project (Fluoxetine)
Study Start Date : July 2001
Primary Completion Date : June 2007
Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Fluoxetine
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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. ]
    Alcohol use behaviors measured by drinks per week.

  2. Depressive Symptoms [ Time Frame: Average score as measured by participant's report on the Beck Depression Inventory (BDI). ]
    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).



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Ages Eligible for Study:   15 Years to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00027378


Locations
United States, Pennsylvania
Western Psychiatric Institute and Clinic
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators
Principal Investigator: Jack Cornelius, M.D. Western Psychiatric Institute and Clinic Pittsburgh

Publications:
Responsible Party: Jack Cornelius, Professor of Psychiatry, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00027378     History of Changes
Other Study ID Numbers: NIAAACOR13370
R01AA015173 ( U.S. NIH Grant/Contract )
R01AA013370 ( U.S. NIH Grant/Contract )
AA-13370
First Posted: December 5, 2001    Key Record Dates
Results First Posted: July 18, 2013
Last Update Posted: July 18, 2013
Last Verified: June 2013

Keywords provided by Jack Cornelius, University of Pittsburgh:
fluoxetine,
adolescents,
alcohol dependence,
major depression
Alcoholism

Additional relevant MeSH terms:
Depression
Alcoholism
Behavioral Symptoms
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Fluoxetine
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors