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

Substance-Related Disorders Clinical Trial

Official title:

Substance Dependent Teens - Impact of Treating Depression Study 1

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00061113
• Other study ID #: NIDA-13176-1
• Secondary ID: R01-13176-1
• Status: Completed
• Phase: Phase 4
• First received: May 21, 2003
• Last updated: January 11, 2017
• Start date: February 2001
• Est. completion date: August 2006

Study information

• Verified date: September 2008
• Source: National Institute on Drug Abuse (NIDA)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: August 2006
• Est. primary completion date: August 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 19 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alcohol-Related Disorders
• Depression
• Disease
• Marijuana Abuse
• Substance-Related Disorders

Intervention

Drug:
• Fluoxetine + outpatient cognitive behavioral therapy
single fixed morning dose 20 mg X 15 weeks
• fluoxetine
20mg, QD x 16 weeks
• placebo + CBT
single fixed morning dose X 16 weeks

Locations

Country	Name	City	State
United States	University of Colorado Denver	Aurora	Colorado
United States	1611 South Federal Blvd.	Denver	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

References & Publications (15)

Davies RD, Gabbert SL, Riggs PD. Anxiety Disorders in Neurologic Illness. Curr Treat Options Neurol. 2001 Jul;3(4):333-346. — View Citation

Davies RD, Thurstone C, Woyewodzic K. Substance Use Disorders and Neurologic Illness. Curr Treat Options Neurol. 2004 Sep;6(5):421-432. — View Citation

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. — View Citation

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. — View Citation

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 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. — View Citation

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. — View Citation

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 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Riggs PD. Treating adolescents for substance abuse and comorbid psychiatric disorders. Sci Pract Perspect. 2003 Aug;2(1):18-29. — View Citation

Riggs, P.D. Understanding the Abuse of Commonly Prescribed Medications and Approaches to Prevention. Current Medical Research and Opinion, 2007

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. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine whether fluoxetine + CBT is a more effective treatment than placebo + CBT for substance outcomes, depression, and behavior problems.		16 weeks	Yes
Secondary	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.		16 weeks	Yes