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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00061113
Recruitment Status : Completed
First Posted : May 22, 2003
Last Update Posted : January 12, 2017
Sponsor:
Information provided by:
National Institute on Drug Abuse (NIDA)

Tracking Information
First Submitted Date  ICMJE May 21, 2003
First Posted Date  ICMJE May 22, 2003
Last Update Posted Date January 12, 2017
Study Start Date  ICMJE February 2001
Actual Primary Completion Date August 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 11, 2008)
To determine whether fluoxetine + CBT is a more effective treatment than placebo + CBT for substance outcomes, depression, and behavior problems. [ Time Frame: 16 weeks ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00061113 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 11, 2008)
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 ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Alcohol-Related Disorders
  • Marijuana Abuse
  • Substance-Related Disorders
Intervention  ICMJE
  • Drug: Fluoxetine + outpatient cognitive behavioral therapy
    single fixed morning dose 20 mg X 15 weeks
    Other Name: Prozac
  • Drug: fluoxetine
    20mg, QD x 16 weeks
    Other Name: prozac
  • Drug: placebo + CBT
    single fixed morning dose X 16 weeks
Study Arms  ICMJE
  • Active Comparator: 1
    fluoxetine + CBT
    Interventions:
    • Drug: Fluoxetine + outpatient cognitive behavioral therapy
    • Drug: fluoxetine
  • Placebo Comparator: 2
    placebo + CBT
    Intervention: Drug: placebo + CBT
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 11, 2008)
126
Original Enrollment  ICMJE
 (submitted: June 23, 2005)
120
Actual Study Completion Date  ICMJE August 2006
Actual 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 13 Years to 19 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00061113
Other Study ID Numbers  ICMJE NIDA-13176-1
R01-13176-1
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Paula Riggs, M.D., University of Colorado Denver
Study Sponsor  ICMJE National Institute on Drug Abuse (NIDA)
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Paula Riggs, M.D. University of Colorado, Denver
PRS Account 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