Substance Dependent Teens - Impact of Treating Depression Study 1 - 1

January 11, 2017 updated by: National Institute on Drug Abuse (NIDA)

Substance Dependent Teens - Impact of Treating Depression Study 1

The purpose of this study is to evaluate the impact of treating depression on substance dependent teens.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The primary study aim is to determine whether fluoxetine + CBT is a more effective treatment than placebo + CBT for substance outcomes, depression, and behavior problems. The current community standard of care often withholds pharmacotherapy for depression in substance abusing adolescents, since it is often assumed that their depressions may remit with SUD treatment alone. However, this is an untested hypothesis in adolescents and one that we propose to test in the current study.

Study Type

Interventional

Enrollment (Actual)

126

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Denver
      • Denver, Colorado, United States, 80219
        • 1611 South Federal Blvd.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years to 19 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Must have DSM IV non bipolar Major Depressive disorder (by clinical interview), DSM IV Conduct Disorder, and Non-Tobacco Substance Disorder.

Exclusion Criteria:

  • History of or current psychosis, history of psychotic depression, bipolar disorder I or II, family history of first degree relative with bipolar I, lifetime history of non-substance induced Mania/Hypomania
  • Unstable chronic or serious medical illness
  • Currently pregnant
  • Take psychotrophic medication, past 2 months: medication or treatment for depression, clinically significant laboratory abnormality

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
fluoxetine + CBT
Drug: Fluoxetine + outpatient cognitive behavioral therapy
single fixed morning dose 20 mg X 15 weeks
Other Names:
  • Prozac
Drug: fluoxetine
20mg, QD x 16 weeks
Other Names:
  • prozac
Placebo Comparator: 2
placebo + CBT
Drug: placebo + CBT
single fixed morning dose X 16 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To determine whether fluoxetine + CBT is a more effective treatment than placebo + CBT for substance outcomes, depression, and behavior problems.
Time Frame: 16 weeks
16 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
To determine if the treatment of depression with fluoxetine + CBT, in depressed adolescents with SUD and CD will be more effective than placebo + CBT in reducing substance use and improving conduct symptoms.
Time Frame: 16 weeks
16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute on Drug Abuse (NIDA)

Investigators

  • Principal Investigator: Paula Riggs, M.D., University of Colorado, Denver

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2001

Primary Completion (Actual)

August 1, 2006

Study Completion (Actual)

August 1, 2006

Study Registration Dates

First Submitted

May 21, 2003

First Submitted That Met QC Criteria

May 21, 2003

First Posted (Estimate)

May 22, 2003

Study Record Updates

Last Update Posted (Estimate)

January 12, 2017

Last Update Submitted That Met QC Criteria

January 11, 2017

Last Verified

September 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIDA-13176-1
  • R01-13176-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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