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

Phase 4

Completed

• Conditions: Alcohol-Related Disorders; Marijuana Abuse; Substance-Related Disorders
• Interventions: Drug: Fluoxetine + outpatient cognitive behavioral therapy; Drug: placebo + CBT; Drug: fluoxetine

• Registration Number: NCT00061113
• Lead Sponsor: National Institute on Drug Abuse (NIDA)

Brief 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.

Study Timeline

• Study Start: 2001-02
• Study First Submitted: 2003-05-21
• Study First Submitted QC: 2003-05-21
• Study First Posted: 2003-05-22
• Primary Completion: 2006-08
• Study Completion: 2006-08
• Status Verified: 2008-09
• Last Update Submitted: 2017-01-11
• Last Update Posted: 2017-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 126

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Fluoxetine + outpatient cognitive behavioral therapy	fluoxetine + CBT
2	placebo + CBT	placebo + CBT
1	fluoxetine	fluoxetine + CBT

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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.	16 weeks

Trial Locations

Locations (2)

1611 South Federal Blvd.; 🇺🇸 Denver, Colorado, United States

University of Colorado Denver; 🇺🇸 Aurora, Colorado, United States