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Treatment Of Resistant Depression In Adolescents (TORDIA)



Treatment Of Resistant Depression In Adolescents (TORDIA)

For Condition: Depression,Major Depressive Disorder,Dysthymic Disorder
Status: Recruiting
Sponsor(s): National Institute of Mental Health (NIMH) ,
Synopsis: 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.
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:
Study Type:
  Interventional, Treatment, Randomized, Double-Blind, Active Control, Factorial Assignment, Efficacy Study
Minimum Age/Maximum Age: 12 Years/18 Years
Genders: Both
Protocol Entry 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
Total Enrollment: 400

Location and Contact Information:

Overall Study Official:
DavidBrent,  Principal Investigator,  Western Psychiatric Institute and Clinic (Data Coordinating Center)

University of California at Los Angeles *Recruiting*
Los Angeles,  California,  90095-6967
United States
Recruiting Annalisa  Enrile 310-267-2573

Brown University *Recruiting*
Providence,  Rhode Island,  02906
United States
Recruiting Marilyn  Matzko 401-444-1970

Kaiser Permanente Center for Health Research *Recruiting*
Portland,  Oregon,  97227-1098
United States
Recruiting Stephanie  Hertert 503-335-2411

University of Texas Medical Branch *Recruiting*
Galveston,  Texas,  77555-0188
United States
Recruiting Nikki  Amaratunge 281-335-5305

University of Texas - Southwestern Medical Center *Recruiting*
Dallas,  Texas,  75390-8589
United States
Recruiting Gerri  Williams 214-648-5338

Western Psychiatric Institute and Clinic of University of Pittsburgh Medical Center *Recruiting*
Pittsburgh,  Pennsylvania,  15213
United States
Recruiting Matthew  Onorato 866-666-2538


Additional Information:
Study ID Numbers:
  TORDIA; 
Study Start Date: January 2001
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00018902

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1. Treatment Of Resistant Depression In Adolescents (TORDIA)

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3. Treatment of Patients with Major Depressive Disorder with an Investigational Compound

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