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

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

Detailed Description
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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.

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

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

Intervention / Treatment
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* Drug: Fluoxetine + outpatient cognitive behavioral therapy
* Drug: fluoxetine
* Drug: placebo + CBT


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>fluoxetine + CBT | Drug: Fluoxetine + outpatient cognitive behavioral therapy<br>* single fixed morning dose 20 mg X 15 weeks<br>* Other names: Prozac;Drug: fluoxetine<br>* 20mg, QD x 16 weeks<br>* Other names: prozac;|
| Placebo Comparator: 2<br>placebo + CBT | Drug: placebo + CBT<br>* single fixed morning dose X 16 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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alcohol dependence, marijuana dependence