We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00061113
First Posted: May 22, 2003
Last Update Posted: January 12, 2017
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.
Information provided by:
National Institute on Drug Abuse (NIDA)
  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
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

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 ]

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 ]

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   13 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
National Institute on Drug Abuse (NIDA)
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
Riggs, P.D. Understanding the Abuse of Commonly Prescribed Medications and Approaches to Prevention. Current Medical Research and Opinion, 2007

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
First Submitted: May 21, 2003
First Posted: May 22, 2003
Last Update Posted: January 12, 2017
Last Verified: September 2008

Keywords provided by National Institute on Drug Abuse (NIDA):
alcohol dependence
marijuana dependence

Additional relevant MeSH terms:
Disease
Depression
Marijuana Abuse
Substance-Related Disorders
Alcohol-Related Disorders
Pathologic Processes
Behavioral Symptoms
Chemically-Induced Disorders
Mental Disorders
Fluoxetine
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors