NCT00061113

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
126

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Feb 2001

Longer than P75 for phase_4

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2001

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

May 21, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 22, 2003

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2006

Completed
Last Updated

January 12, 2017

Status Verified

September 1, 2008

Enrollment Period

5.5 years

First QC Date

May 21, 2003

Last Update Submit

January 11, 2017

Conditions

Alcohol-Related DisordersMarijuana AbuseSubstance-Related Disorders

Keywords

alcohol dependencemarijuana dependence

Outcome Measures

Primary Outcomes (1)

  • To determine whether fluoxetine + CBT is a more effective treatment than placebo + CBT for substance outcomes, depression, and behavior problems.

    16 weeks

Secondary Outcomes (1)

  • 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

Study Arms (2)

1

ACTIVE COMPARATOR

fluoxetine + CBT

Drug: Fluoxetine + outpatient cognitive behavioral therapyDrug: fluoxetine

2

PLACEBO COMPARATOR

placebo + CBT

Drug: placebo + CBT

Interventions

Fluoxetine + outpatient cognitive behavioral therapyDRUG

single fixed morning dose 20 mg X 15 weeks

Also known as: Prozac
1
fluoxetineDRUG

20mg, QD x 16 weeks

Also known as: prozac
1
placebo + CBTDRUG

single fixed morning dose X 16 weeks

2

Eligibility Criteria

Age13 Years - 19 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Must have DSM IV non bipolar Major Depressive disorder (by clinical interview), DSM IV Conduct Disorder, and Non-Tobacco Substance Disorder.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Colorado Denver

Aurora, Colorado, 80045, United States

Location

1611 South Federal Blvd.

Denver, Colorado, 80219, United States

Location

Related Publications (14)

  • 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.

    PMID: 10698377BACKGROUND

  • 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.

    PMID: 11389804BACKGROUND

  • 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.

    PMID: 12364848BACKGROUND

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

    PMID: 18552718BACKGROUND

  • 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.

    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.

    PMID: 15187802BACKGROUND

  • 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.

    PMID: 15279762BACKGROUND

  • 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.

    PMID: 16098679BACKGROUND

  • 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.

    PMID: 16262598BACKGROUND

  • 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.

    PMID: 17003670BACKGROUND

  • 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.

    PMID: 17712241BACKGROUND

  • 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.

    PMID: 18267053BACKGROUND

  • 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.

    PMID: 17984403BACKGROUND

  • 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.

    PMID: 18038460BACKGROUND

MeSH Terms

Conditions

Alcohol-Related DisordersMarijuana AbuseSubstance-Related DisordersAlcoholism

Interventions

Fluoxetine

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PropylaminesAminesOrganic Chemicals

Study Officials

  • Paula Riggs, M.D.

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

May 21, 2003

First Posted

May 22, 2003

Study Start

February 1, 2001

Primary Completion

August 1, 2006

Study Completion

August 1, 2006

Last Updated

January 12, 2017

Record last verified: 2008-09

Locations

US(2)