Treatment of SSRI-Resistant Depression In Adolescents (TORDIA) - Full Text View

Sponsor:	National Institute of Mental Health (NIMH)
Information provided by:	National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:	NCT00018902

Purpose

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.

Condition	Intervention	Phase
Depression	Drug: fluoxetine (Prozac) Drug: venlafaxine (Effexor XR) Procedure: Cognitive Behavioral Therapy (CBT) Drug: citalopram (Celexa)	Phase II Phase III

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

Resource links provided by NLM:

MedlinePlus related topics: Antidepressants Depression

Drug Information available for: Benzetimide Dexetimide Fluoxetine Fluoxetine hydrochloride Citalopram hydrobromide Citalopram Venlafaxine Venlafaxine hydrochloride Escitalopram Escitalopram oxalate

U.S. FDA Resources

Further study details as provided by National Institute of Mental Health (NIMH):

Enrollment:	334
Study Start Date:	January 2001
Study Completion Date:	January 2007

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.

Eligibility

Ages Eligible for Study:	12 Years to 18 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00018902

Locations

United States, California
University of California at Los Angeles
Los Angeles, California, United States, 90095-6967
United States, Oregon
Kaiser Permanente Center for Health Research
Portland, Oregon, United States, 97227-1098
United States, Pennsylvania
Western Psychiatric Institute and Clinic of University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
United States, Rhode Island
Brown University
Providence, Rhode Island, United States, 02906
United States, Texas
University of Texas Medical Branch
Galveston, Texas, United States, 77555-0188
University of Texas - Southwestern Medical Center
Dallas, Texas, United States, 75390-8589

Sponsors and Collaborators

National Institute of Mental Health (NIMH)

Investigators

Principal Investigator:

David Brent, M.D.

Western Psychiatric Institute and Clinic (Data Coordinating Center)

More Information

Additional Information:

Click here for more information about this study: Treatment of Resistant Depression in Adolescents This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

Publications:

Brent D, Emslie G, Clarke G, Wagner KD, Asarnow JR, Keller M, Vitiello B, Ritz L, Iyengar S, Abebe K, Birmaher B, Ryan N, Kennard B, Hughes C, DeBar L, McCracken J, Strober M, Suddath R, Spirito A, Leonard H, Melhem N, Porta G, Onorato M, Zelazny J. Switching to another SSRI or to venlafaxine with or without cognitive behavioral therapy for adolescents with SSRI-resistant depression: the TORDIA randomized controlled trial. JAMA. 2008 Feb 27;299(8):901-13.

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:	U01 MH61835, TORDIA, DSIR B4-ARD
Study First Received:	July 10, 2001
Last Updated:	February 27, 2008
ClinicalTrials.gov Identifier:	NCT00018902 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by National Institute of Mental Health (NIMH):

Depressive Disorder
Adolescents
Teenagers
Teens
cognitive behavior therapy

Additional relevant MeSH terms:

Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Depression
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Depressive Disorder
Serotonin Uptake Inhibitors
Citalopram
Pharmacologic Actions

Behavioral Symptoms
Fluoxetine
Serotonin Agents
Mental Disorders
Therapeutic Uses
Venlafaxine
Mood Disorders
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on November 27, 2009