Treatment of SSRI-Resistant Depression In Adolescents (TORDIA)

Condition(s) targeted: Depression

Intervention: fluoxetine (Prozac) (Drug); venlafaxine (Effexor XR) (Drug); Cognitive Behavioral Therapy (CBT) (Procedure); citalopram (Celexa) (Drug)

Phase: Phase 2/Phase 3

Status: Completed

Sponsored by: National Institute of Mental Health (NIMH)

Official(s) and/or principal investigator(s):
David Brent, M.D., Principal Investigator, Affiliation: Western Psychiatric Institute and Clinic (Data Coordinating Center)

The purpose of the study is to determine how best to treat adolescents with depression that is "resistant" to the first SSRI antidepressant they have tried. Participants receive one of three other antidepressant medications, either alone or in combination with cognitive behavioral therapy.

Study design: Treatment, Randomized, Double-Blind, Active Control, Factorial Assignment, Efficacy Study

Detailed description: 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.

Minimum age: 12 Years. Maximum age: 18 Years. Gender(s): 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

University of California at Los Angeles, Los Angeles, California 90095-6967, United States

Kaiser Permanente Center for Health Research, Portland, Oregon 97227-1098, United States

Western Psychiatric Institute and Clinic of University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania 15213, United States

Brown University, Providence, Rhode Island 02906, United States

University of Texas Medical Branch, Galveston, Texas 77555-0188, United States

University of Texas - Southwestern Medical Center, Dallas, Texas 75390-8589, United States

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

Related 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.

Starting date: January 2001
Ending date: January 2007
Last updated: December 5, 2007