The purpose of this study is to evaluate the impact of treating depression on substance dependent teens...
Date First Received: May 21, 2003
Last Updated: September 11, 2008
Verified by: National Institute on Drug Abuse (NIDA), September 2008
Clinical Trial Phase: Phase 4 | Start Date: February 2001
Overall Status: Completed
Estimated Enrollment: 126
Brief Summary
Official Title: “Substance Dependent Teens - Impact of Treating Depression Study 1”
Condition Keyword(s):
The purpose of this study is to evaluate the impact of treating depression on substance dependent teens.
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Study Primary Completion Date: August 2006
Detailed Clinical Trial 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.
Intervention(s) in this Clinical Trial
- Drug: Fluoxetine + outpatient cognitive behavioral therapy
- single fixed morning dose 20 mg X 15 weeks
- Drug: fluoxetine
- 20mg, QD x 16 weeks
- Drug: placebo + CBT
- single fixed morning dose X 16 weeks
Arms, Groups and Cohorts in this Clinical Trial
- Active Comparator: 1
- fluoxetine + CBT
- Placebo Comparator: 2
- placebo + CBT
Outcome Measures for this Clinical Trial
Primary 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
Safety Issue?: Yes
- Time Frame: 16 weeks
Secondary 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
Safety Issue?: Yes
- Time Frame: 16 weeks
Criteria for Participation in this Clinical Trial
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 Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 13 Years
Maximum Age for this Clinical Trial: 19 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: National Institute on Drug Abuse (NIDA)
Overall Clinical Trial Officials and Contacts
Paula Riggs, M.D. Principal Investigator University of Colorado at Denver and Health Sciences Center
Related Publications
References
Deas D, Riggs P, Langenbucher J, Goldman M, Brown S. Adolescents are not adults: developmental considerations in alcohol users. Alcohol Clin Exp Res. 2000 Feb;24(2):232-7.
Davies RD, Gabbert SL, Riggs PD. Anxiety Disorders in Neurologic Illness. Curr Treat Options Neurol. 2001 Jul;3(4):333-346.
Riggs PD, Davies RD. A clinical approach to integrating treatment for adolescent depression and substance abuse. J Am Acad Child Adolesc Psychiatry. 2002 Oct;41(10):1253-5. No abstract available.
Riggs PD. Treating adolescents for substance abuse and comorbid psychiatric disorders. Sci Pract Perspect. 2003 Aug;2(1):18-29.
Riggs PD, Hall SK, Mikulich-Gilbertson SK, Lohman M, Kayser A. A randomized controlled trial of pemoline for attention-deficit/hyperactivity disorder in substance-abusing adolescents. J Am Acad Child Adolesc Psychiatry. 2004 Apr;43(4):420-9.
Davies RD, Thurstone C, Woyewodzic K. Substance Use Disorders and Neurologic Illness. Curr Treat Options Neurol. 2004 Sep;6(5):421-432.
Libby AM, Orton HD, Stover SK, Riggs PD. What came first, major depression or substance use disorder? Clinical characteristics and substance use comparing teens in a treatment cohort. Addict Behav. 2005 Oct;30(9):1649-62. Epub 2005 Aug 11.
Libby AM, Riggs PD. Integrated substance use and mental health treatment for adolescents: aligning organizational and financial incentives. J Child Adolesc Psychopharmacol. 2005 Oct;15(5):826-34. Review.
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
Drell MJ, Josephson A, Pleak R, Riggs P, Rosenfeld A. Clinical problem solving: the case of John, Part II: excerpts from Sessions 2-7. J Am Acad Child Adolesc Psychiatry. 2006 Oct;45(10):1243-51. No abstract available.
Thurstone C, Riggs PD, Klein C, Mikulich-Gilbertson SK. A one-session human immunodeficiency virus risk-reduction intervention in adolescents with psychiatric and substance use disorders. J Am Acad Child Adolesc Psychiatry. 2007 Sep;46(9):1179-86.
Riggs PD, Mikulich-Gilbertson SK, Davies RD, Lohman M, Klein C, Stover SK. A randomized controlled trial of fluoxetine and cognitive behavioral therapy in adolescents with major depression, behavior problems, and substance use disorders. Arch Pediatr Adolesc Med. 2007 Nov;161(11):1026-34.
Riggs PD, Thompson LL, Tapert SF, Frascella J, Mikulich-Gilbertson S, Dalwani M, Laudenslager M, Lohman M. Advances in neurobiological research related to interventions in adolescents with substance use disorders: research to practice. Drug Alcohol Depend. 2007 Dec 1;91(2-3):306-11. No abstract available.
Citations Reporting Results
Riggs PD, Mikulich-Gilbertson SK, Davies RD, Lohman M, Klein C, Stover SK. A randomized controlled trial of fluoxetine and cognitive behavioral therapy in adolescents with major depression, behavior problems, and substance use disorders. Arch Pediatr Adolesc Med. 2007 Nov;161(11):1026-34.
Additional Information
Information obtained from ClinicalTrials.gov on January 06, 2009
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00061113
Study ID Number: NIDA-13176-1
ClinicalTrials.gov Identifier: NCT00061113
Health Authority: United States: Federal Government
Clinical Trials Authorship and Review
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