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Volume 6 Issue 231 Published - 14:00 UTC 08:00 EST 18-Aug-2004 Next Update - 14:00 UTC 08:00 EST 19-Aug-2004
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Clinical trial information: Treatment Of Resistant Depression In Adolescents (TORDIA)

This study is currently recruiting patients.

Purpose

This is a study of depression in adolescents, ages 12 to 18, who are currently taking a prescribed selective serotonin reuptake inhibitor (SSRI) antidepressant medication but are still experiencing depression. The purpose of the study is to determine how best to treat adolescents with depression that is "resistant" to the first SSRI they have tried. In addition to receiving a complete psychiatric evaluation, participants will be randomly assigned to receive one of three other antidepressant medications, either alone or in combination with cognitive behavioral therapy. Participants will be monitored for 24 weeks and will receive follow-up psychiatric evaluations for one year.

Condition Treatment or Intervention Phase
Major Depressive Disorder
Dysthymic Disorder
Depression
 Drug: fluoxetine (Prozac)
 Drug: venlafaxine (Effexor XR)
 Procedure: Cognitive Behavioral Therapy (CBT)
 Drug: citalopram (Celexa)
Phase III

MedlinePlus related topics:  Depression;   Mental Health

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Active Control, Factorial Assignment, Efficacy Study

Further Study Details: 

The TORDIA study aims to develop useful clinical guidelines for the care and management of adolescent depression. Adolescents ages 12 to 18, currently taking a prescribed selective serotonin reuptake inhibitor (SSRI) and still experiencing depression, participate in a 12-week randomized treatment study that includes one of four conditions: (1) switching to an alternative SSRI, (2) switching to a different non-SSRI antidepressant, (3) switching to an alternative SSRI and receiving cognitive behavioral therapy (CBT), or (4) switching to a different non-SSRI antidepressant and receiving CBT. This is a double-blind study, which means that neither the participant nor the clinical staff will know which of the three possible medications has been assigned. Participants who respond to the assigned treatment will receive 12 additional weeks of the same treatment. Those who do not appear to be getting better will be offered 12 weeks of an alternative, individualized treatment plan based on each participant's particular needs. All participants will receive follow-up psychiatric evaluations for 12 months after the 12-week continuation phase of the study, regardless of treatment adherence.

Eligibility

Ages Eligible for Study:  12 Years   -   18 Years,  Genders Eligible for Study:  Both

Criteria

  • between the ages of 12 and 18 years 11 months
  • currently in treatment for depression
  • taking Prozac,Zoloft, Luvox, Lexapro, Celexa or Paxil (Oregon and Rhode Island sites only)
  • still feeling depressed

Expected Total Enrollment:  400

Location and Contact Information

Matthew Onorato, LCSW, CCRC      1-866-666-2538    onoratomj@msx.upmc.edu

California
      University of California at Los Angeles, Los Angeles,  California,  90095-6967,  United States; Recruiting
Annalisa Enrile, M.S.W.  310-267-2573    aenrile@mednet.ucla.edu 
Joan Asarnow, Ph.D.,  Principal Investigator
James McCracken, M.D.,  Sub-Investigator
Caroly Pataki, M.D.,  Sub-Investigator
Michael Strober, Ph.D.,  Sub-Investigator

Oregon
      Kaiser Permanente Center for Health Research, Portland,  Oregon,  97227-1098,  United States; Recruiting
Stephanie Hertert, M.Ed., CCRC  503-335-2411    Stephanie.hertert@kp.org 
Greg Clarke, Ph.D.,  Principal Investigator
Lynn Debar, Ph.D.,  Sub-Investigator
John Gale, M.D.,  Sub-Investigator
Frances Lynch, Ph.D.,  Sub-Investigator

Pennsylvania
      Western Psychiatric Institute and Clinic of University of Pittsburgh Medical Center, Pittsburgh,  Pennsylvania,  15213,  United States; Recruiting
Matthew Onorato, LCSW, CCRC  866-666-2538    onoratomj@msx.upmc.com 
David Brent, M.D.,  Principal Investigator
Boris Birmaher, M.D.,  Sub-Investigator
Neal Ryan, M.D.,  Sub-Investigator

Rhode Island
      Brown University, Providence,  Rhode Island,  02906,  United States; Recruiting
Marilyn Matzko, Ed. D.  401-444-1970    Marilyn_Matzko@brown.edu 
Martin Keller, M.D.,  Principal Investigator
Henrietta Leonard, M.D.,  Sub-Investigator
Anthony Spirito, Ph.D.,  Sub-Investigator

Texas
      University of Texas Medical Branch, Galveston,  Texas,  77555-0188,  United States; Recruiting
Nikki Amaratunge, M. A.  281-335-5305    naamarat@utmb.edu 
Karen Wagner, M.D., Ph.D,  Principal Investigator
Joan Hebelar, M.D.,  Sub-Investigator

      University of Texas - Southwestern Medical Center, Dallas,  Texas,  75390-8589,  United States; Recruiting
Gerri Williams, M.S.  214-648-5338    Geraldine.Williams@utsouthwestern.edu 
Taryn Mayes, M.S.  214-648-4379 
Graham Emslie, M.D.,  Principal Investigator
Betsy Kennard, Psy.D.,  Sub-Investigator

Study chairs or principal investigators

David Brent, M.D.,  Principal Investigator,  Western Psychiatric Institute and Clinic (Data Coordinating Center)   

More Information

Click here for more information about this study: Treatment of Resistant Depression in Adolescents

Publications

Brent DA, Holder D, Kolko D, Birmaher B, Baugher M, Roth C, Iyengar S, Johnson BA. A clinical psychotherapy trial for adolescent depression comparing cognitive, family, and supportive therapy. Arch Gen Psychiatry. 1997 Sep;54(9):877-85.

Emslie GJ, Rush AJ, Weinberg WA, Kowatch RA, Hughes CW, Carmody T, Rintelmann J. A double-blind, randomized, placebo-controlled trial of fluoxetine in children and adolescents with depression. Arch Gen Psychiatry. 1997 Nov;54(11):1031-7.

Keller MB, Ryan ND, Birmaher B, Klein RG, Strober M, Wagner KD, Weller EB: Paroxetine and imipramine in the treatment of adolescent depression. New Research Program Abstracts. Annual Meeting of the American Psychiatric Association [123], 1998.

Study ID Numbers  TORDIA
Study Start Date January 2001;  Estimated Completion Date  March 2005
Record last reviewed  March 2004
NLM Identifier  NCT00018902
ClinicalTrials.gov processed this record on 2004-08-17
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