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

Sponsor

National Institute on Drug Abuse (NIDA) (NIH)

Overall Status

Completed

CT.gov ID

NCT00061113

Collaborator

(none)

126

Enrollment

Locations

Arms

65.9

Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Alcohol-Related Disorders Marijuana Abuse Substance-Related Disorders	Drug: Fluoxetine + outpatient cognitive behavioral therapy Drug: fluoxetine Drug: placebo + CBT	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

126 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Substance Dependent Teens - Impact of Treating Depression Study 1

Study Start Date :

Feb 1, 2001

Actual Primary Completion Date :

Aug 1, 2006

Actual Study Completion Date :

Aug 1, 2006

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1 fluoxetine + CBT	Drug: Fluoxetine + outpatient cognitive behavioral therapy single fixed morning dose 20 mg X 15 weeks Other Names: Prozac Drug: fluoxetine 20mg, QD x 16 weeks Other Names: prozac
Placebo Comparator: 2 placebo + CBT	Drug: placebo + CBT single fixed morning dose X 16 weeks

Arm

Intervention/Treatment

Active Comparator: 1

fluoxetine + CBT

Drug: Fluoxetine + outpatient cognitive behavioral therapy

single fixed morning dose 20 mg X 15 weeks

Other Names:

Prozac

Drug: fluoxetine

20mg, QD x 16 weeks

Other Names:

prozac

Placebo Comparator: 2

placebo + CBT

Drug: placebo + CBT

single fixed morning dose X 16 weeks

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

13 Years to 19 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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