Clinical Trials Directory

Trials / Completed

CompletedNCT00061113

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

Substance Dependent Teens - Impact of Treating Depression Study 1

Status
Completed
Phase
Phase 4
Study type
Interventional
Enrollment
126 (actual)
Sponsor
National Institute on Drug Abuse (NIDA) · NIH
Sex
All
Age
13 Years – 19 Years
Healthy volunteers
Not accepted

Summary

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

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.

Conditions

Interventions

TypeNameDescription
DRUGFluoxetine + outpatient cognitive behavioral therapysingle fixed morning dose 20 mg X 15 weeks
DRUGfluoxetine20mg, QD x 16 weeks
DRUGplacebo + CBTsingle fixed morning dose X 16 weeks

Timeline

Start date
2001-02-01
Primary completion
2006-08-01
Completion
2006-08-01
First posted
2003-05-22
Last updated
2017-01-12

Locations

2 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT00061113. Inclusion in this directory is not an endorsement.