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

Substance Dependent Teens - Impact of Treating Depression Study 1

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00061113
Enrollment
126
Registered
2003-05-22
Start date
2001-02-28
Completion date
2006-08-31
Last updated
2017-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcohol-Related Disorders, Marijuana Abuse, Substance-Related Disorders

Keywords

alcohol dependence, marijuana dependence

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.

Interventions

DRUGplacebo + CBT

single fixed morning dose X 16 weeks

DRUGFluoxetine + outpatient cognitive behavioral therapy

single fixed morning dose 20 mg X 15 weeks

DRUGfluoxetine

20mg, QD x 16 weeks

Sponsors

National Institute on Drug Abuse (NIDA)
Lead SponsorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
13 Years to 19 Years
Healthy volunteers
No

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

Design outcomes

Primary

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

Secondary

MeasureTime 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.16 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026