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Completed

NCT Number: NCT00061113

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

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

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Key information

Conditions

Alcohol-Related Disorders Alcoholism Chemically-Induced Disorders Marijuana Abuse Mental Disorders Substance-Related Disorders

Age range

13 year–19 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Colorado Denver, Aurora, Colorado, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fluoxetine + outpatient cognitive behavioral therapy

Drug

single fixed morning dose 20 mg X 15 weeks

Other names: Prozac

Fluoxetine

Drug

20mg, QD x 16 weeks

Other names: prozac

placebo + CBT

Drug

single fixed morning dose X 16 weeks

Primary outcomes

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

    Time frame: 16 weeks

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

National Institute on Drug Abuse (NIDA)

Nih

Registry information

Official study title

Substance Dependent Teens - Impact of Treating Depression Study 1

Important dates

Study start
2001
Primary completion
2006
Study completion
2006
First posted
May 22, 2003
Registry last updated
Jan 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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