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

Tracking Information

First Received Date ^ICMJE

May 21, 2003

Last Updated Date

September 11, 2008

Start Date ^ICMJE

February 2001

Primary Completion Date

August 2006 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

To determine whether fluoxetine + CBT is a more effective treatment than placebo + CBT for substance outcomes, depression, and behavior problems. [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00061113 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Substance Dependent Teens - Impact of Treating Depression Study 1

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 Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Alcohol-Related Disorders
Marijuana Abuse
Substance-Related Disorders

Intervention ^ICMJE

Drug: Fluoxetine + outpatient cognitive behavioral therapy
Drug: fluoxetine
Drug: placebo + CBT

Study Arms / Comparison Groups

Active Comparator: fluoxetine + CBT
Placebo Comparator: placebo + CBT

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

126

Completion Date

August 2006

Primary Completion Date

August 2006 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

13 Years to 19 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00061113

Responsible Party

Paula Riggs, M.D., University of Colorado Denver

Study ID Numbers ^ICMJE

NIDA-13176-1, R01-13176-1

Study Sponsor ^ICMJE

National Institute on Drug Abuse (NIDA)

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Paula Riggs, M.D.

University of Colorado at Denver and Health Sciences Center

Information Provided By

National Institute on Drug Abuse (NIDA)

Verification Date

September 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP