Pharmacological Intervention Project (Fluoxetine)

NCT ID: NCT00027378

Last Updated: 2013-07-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-07-31
• Study Completion Date: 2008-06-30

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.

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.

Conditions

Alcoholism; Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

1

fluoxetine plus Treatment As Usual (TAU)

Group Type: EXPERIMENTAL

fluoxetine (Prozac)

Intervention Type: DRUG

fluoxetine plus Treatment As Usual (TAU); 12 weeks acute phase; plus 9 month naturalistic follow up

2

placebo plus Treatment As Usual (TAU)

Group Type: PLACEBO_COMPARATOR

Placebo plus Treatment As Usual

Intervention Type: DRUG

placebo plus Treatment as Usual; 12 weeks acute phase; plus 9 month naturalistic follow up

Interventions

fluoxetine (Prozac)

fluoxetine plus Treatment As Usual (TAU); 12 weeks acute phase; plus 9 month naturalistic follow up

Intervention Type: DRUG

Placebo plus Treatment As Usual

placebo plus Treatment as Usual; 12 weeks acute phase; plus 9 month naturalistic follow up

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role: collaborator

University of Pittsburgh

OTHER

Sponsor Role: lead

Responsible Party

Jack Cornelius

Professor of Psychiatry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jack Cornelius, M.D.

Role: PRINCIPAL_INVESTIGATOR

Western Psychiatric Institute and Clinic Pittsburgh

Locations

Western Psychiatric Institute and Clinic

Pittsburgh, Pennsylvania, United States

Countries

United States

References

Cornelius JR, Bukstein OG, Wood DS, Kirisci L, Douaihy A, Clark DB. Double-blind placebo-controlled trial of fluoxetine in adolescents with comorbid major depression and an alcohol use disorder. Addict Behav. 2009 Oct;34(10):905-9. doi: 10.1016/j.addbeh.2009.03.008. Epub 2009 Mar 12.

Reference Type: RESULT

PMID: 19321268 (View on PubMed)

Other Identifiers

R01AA015173

Identifier Type: NIH

Identifier Source: secondary_id

View Link

R01AA013370

Identifier Type: NIH

Identifier Source: secondary_id

View Link

AA-13370

Identifier Type: -

Identifier Source: secondary_id

NIAAACOR13370

Identifier Type: -

Identifier Source: org_study_id