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Sponsored by: |
National Institute on Drug Abuse (NIDA) |
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Information provided by: | National Institute on Drug Abuse (NIDA) |
ClinicalTrials.gov Identifier: | NCT00061113 |
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 IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Substance Dependent Teens - Impact of Treating Depression Study 1 |
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 |
---|---|
1: Active Comparator
fluoxetine + CBT
|
Drug: Fluoxetine + outpatient cognitive behavioral therapy
single fixed morning dose 20 mg X 15 weeks
Drug: fluoxetine
20mg, QD x 16 weeks
|
2: Placebo Comparator
placebo + CBT
|
Drug: placebo + CBT
single fixed morning dose X 16 weeks
|
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.
Ages Eligible for Study: | 13 Years to 19 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Colorado | |
University of Colorado Denver | |
Aurora, Colorado, United States, 80045 | |
1611 South Federal Blvd. | |
Denver, Colorado, United States, 80219 |
Principal Investigator: | Paula Riggs, M.D. | University of Colorado at Denver and Health Sciences Center |
Responsible Party: | University of Colorado Denver ( Paula Riggs, M.D. ) |
Study ID Numbers: | NIDA-13176-1, R01-13176-1 |
Study First Received: | May 21, 2003 |
Last Updated: | September 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00061113 |
Health Authority: | United States: Federal Government |
Fluoxetine Depression Mental Disorders Substance-Related Disorders Disorders of Environmental Origin |
Alcohol-Related Disorders Depressive Disorder Marijuana Abuse Serotonin Behavioral Symptoms |
Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Disease Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Psychotropic Drugs Serotonin Uptake Inhibitors |
Pharmacologic Actions Pathologic Processes Serotonin Agents Therapeutic Uses Antidepressive Agents, Second-Generation Central Nervous System Agents Antidepressive Agents |