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

This study has been completed.
Sponsor:
Information provided by:
National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:
NCT00061113
First received: May 21, 2003
Last updated: September 11, 2008
Last verified: September 2008
  Purpose

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


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Substance Dependent Teens - Impact of Treating Depression Study 1

Resource links provided by NLM:


Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:
  • 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 ]

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. [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 126
Study Start Date: February 2001
Study Completion Date: August 2006
Primary Completion Date: August 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
fluoxetine + CBT
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
Placebo Comparator: 2
placebo + CBT
Drug: placebo + CBT
single fixed morning dose X 16 weeks

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.

  Eligibility

Ages Eligible for Study:   13 Years to 19 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00061113

Locations
United States, Colorado
University of Colorado Denver
Aurora, Colorado, United States, 80045
1611 South Federal Blvd.
Denver, Colorado, United States, 80219
Sponsors and Collaborators
Investigators
Principal Investigator: Paula Riggs, M.D. University of Colorado, Denver
  More Information

Publications:
Laudenslager, M.L., Neu, M., Riggs, P., Goldstein, M., & Lohman, M. Refinements in a novel technique for collecting saliva for steroid hormone determinations. Brain Behavior, and Immunity, 17 (3), 186, 2003.
Libby, A.M. and Riggs, P.D. The Economics of Integrated Care for Adolescents with Mental and Substance Use Disorders. Journal of Child and Adolescent Psychopharmacology, 15(5): October 2005

Responsible Party: Paula Riggs, M.D., University of Colorado Denver
ClinicalTrials.gov Identifier: NCT00061113     History of Changes
Other Study ID Numbers: NIDA-13176-1, R01-13176-1
Study First Received: May 21, 2003
Last Updated: September 11, 2008
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Depression
Depressive Disorder
Marijuana Abuse
Alcohol-Related Disorders
Substance-Related Disorders
Behavioral Symptoms
Mood Disorders
Mental Disorders
Fluoxetine
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 16, 2014