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

Further Study Details: 

Expected Total Enrollment:  400

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.

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

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

Study chairs or principal investigators

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

Study ID Numbers:  TORDIA
Record last reviewed:  March 2005
Last Updated:  March 3, 2005
Record first received:  July 10, 2001
ClinicalTrials.gov Identifier:  NCT00018902
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08