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

NCT ID: NCT00061113

Last Updated: 2017-01-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

126 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-02-28

Study Completion Date

2006-08-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Alcohol-Related Disorders Marijuana Abuse Substance-Related Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

fluoxetine + CBT

Group Type ACTIVE_COMPARATOR

Fluoxetine + outpatient cognitive behavioral therapy

Intervention Type DRUG

single fixed morning dose 20 mg X 15 weeks

fluoxetine

Intervention Type DRUG

20mg, QD x 16 weeks

2

placebo + CBT

Group Type PLACEBO_COMPARATOR

placebo + CBT

Intervention Type DRUG

single fixed morning dose X 16 weeks

Interventions

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Fluoxetine + outpatient cognitive behavioral therapy

single fixed morning dose 20 mg X 15 weeks

Intervention Type DRUG

fluoxetine

20mg, QD x 16 weeks

Intervention Type DRUG

placebo + CBT

single fixed morning dose X 16 weeks

Intervention Type DRUG

Other Intervention Names

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Prozac prozac

Eligibility Criteria

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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
Minimum Eligible Age

13 Years

Maximum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role lead

Responsible Party

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University of Colorado Denver

Principal Investigators

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Paula Riggs, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

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University of Colorado Denver

Aurora, Colorado, United States

Site Status

1611 South Federal Blvd.

Denver, Colorado, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 10698377 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11389804 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12364848 (View on PubMed)

Riggs PD. Treating adolescents for substance abuse and comorbid psychiatric disorders. Sci Pract Perspect. 2003 Aug;2(1):18-29. doi: 10.1151/spp032118.

Reference Type BACKGROUND
PMID: 18552718 (View on PubMed)

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.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 15187802 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15279762 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16098679 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16262598 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17003670 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17712241 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18267053 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17984403 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18038460 (View on PubMed)

Other Identifiers

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R01-13176-1

Identifier Type: -

Identifier Source: secondary_id

NIDA-13176-1

Identifier Type: -

Identifier Source: org_study_id

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