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
| Type | Name | Description |
|---|---|---|
| DRUG | Fluoxetine + outpatient cognitive behavioral therapy | single fixed morning dose 20 mg X 15 weeks |
| DRUG | fluoxetine | 20mg, QD x 16 weeks |
| DRUG | placebo + CBT | single 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.