NCT00027378

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jul 2001

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2001

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 4, 2001

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 5, 2001

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
5.1 years until next milestone

Results Posted

Study results publicly available

July 18, 2013

Completed
Last Updated

July 18, 2013

Status Verified

June 1, 2013

Enrollment Period

5.9 years

First QC Date

December 4, 2001

Results QC Date

February 8, 2012

Last Update Submit

June 17, 2013

Conditions

AlcoholismDepression

Keywords

fluoxetine,adolescents,alcohol dependence,major depressionAlcoholism

Outcome Measures

Primary Outcomes (2)

  • Alcohol Use Behaviors

    Alcohol use behaviors measured by drinks per week.

    Average number of drinks as recorded on the Timeline Follow-Back (subject-reported) measure daily over the 12-week acute phase.

  • Depressive Symptoms

    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).

    Average score as measured by participant's report on the Beck Depression Inventory (BDI).

Study Arms (2)

1

EXPERIMENTAL

fluoxetine plus Treatment As Usual (TAU)

Drug: fluoxetine (Prozac)

2

PLACEBO COMPARATOR

placebo plus Treatment As Usual (TAU)

Drug: Placebo plus Treatment As Usual

Interventions

fluoxetine (Prozac)DRUG

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

1
Placebo plus Treatment As UsualDRUG

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

2

Eligibility Criteria

Age15 Years - 20 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Western Psychiatric Institute and Clinic

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (1)

  • 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.

    PMID: 19321268RESULT

MeSH Terms

Conditions

AlcoholismDepressionDepressive Disorder, Major

Interventions

FluoxetineTherapeutics

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental DisordersBehavioral SymptomsBehaviorDepressive DisorderMood Disorders

Intervention Hierarchy (Ancestors)

PropylaminesAminesOrganic Chemicals

Limitations and Caveats

Limited sample size; efficacy of CBT/MET Therapy

Results Point of Contact

Title
Jack R. Cornelius, M.D., M.P.H.
Organization
University of Pittsburgh
corneliusjr@upmc.edu
412-246-5149

Study Officials

  • Jack Cornelius, M.D.

    Western Psychiatric Institute and Clinic Pittsburgh

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Psychiatry

Study Record Dates

First Submitted

December 4, 2001

First Posted

December 5, 2001

Study Start

July 1, 2001

Primary Completion

June 1, 2007

Study Completion

June 1, 2008

Last Updated

July 18, 2013

Results First Posted

July 18, 2013

Record last verified: 2013-06

Locations

US(1)