Clinical trial NCT00061113: Substance Dependent Teens - Impact of Treating Depression Study 1 - 1
Official title: Substance Dependent Teens - Impact of Treating Depression Study 1
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Alcohol-Related Disorders
Marijuana Abuse
Substance-Related Disorders
Keywords: alcohol dependence
marijuana dependence
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
First posted: 2003-05-22
Enrollment: 126
Sex: ALL
Minimum age (years): 13
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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 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

Primary outcomes:
measure: To determine whether fluoxetine + CBT is a more effective treatment than placebo + CBT for substance outcomes, depression, and behavior problems.
timeFrame: 16 weeks
Secondary outcomes:
measure: 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.
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Denver
state: Colorado
city: Denver
country: United States
facility: 1611 South Federal Blvd.
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Paula Riggs, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: Davies RD, Gabbert SL, Riggs PD. Anxiety Disorders in Neurologic Illness. Curr Treat Options Neurol. 2001 Jul;3(4):333-346. doi: 10.1007/s11940-001-0038-1.
citation: 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. doi: 10.1097/00004583-200210000-00016. No abstract available.
citation: Riggs PD. Treating adolescents for substance abuse and comorbid psychiatric disorders. Sci Pract Perspect. 2003 Aug;2(1):18-29. doi: 10.1151/spp032118.
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.
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. doi: 10.1097/00004583-200404000-00008.
citation: Davies RD, Thurstone C, Woyewodzic K. Substance Use Disorders and Neurologic Illness. Curr Treat Options Neurol. 2004 Sep;6(5):421-432. doi: 10.1007/s11940-996-0032-8.
citation: 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. doi: 10.1016/j.addbeh.2005.07.012. Epub 2005 Aug 11.
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. doi: 10.1089/cap.2005.15.826.
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. doi: 10.1097/01.chi.0000230164.46493.8c. No abstract available.
citation: 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):1179-1186. doi: 10.1097/chi.0b013e31809fe774.
citation: Riggs P. Non-medical use and abuse of commonly prescribed medications. Curr Med Res Opin. 2008 Mar;24(3):869-77. doi: 10.1185/030079908X273435. Epub 2008 Feb 8.
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. doi: 10.1001/archpedi.161.11.1026.
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. doi: 10.1016/j.drugalcdep.2007.03.003. No abstract available.