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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
334
Standard anti-depressant treatment with the SSRI fluoxetine
Standard antidepressant treatment with the non-SSRI medication venlafaxine
CBT addresses maladaptive beliefs in order to encourage behavioral change
University of California at Los Angeles
Los Angeles, California, United States
Kaiser Permanente Center for Health Research
Portland, Oregon, United States
Western Psychiatric Institute and Clinic of University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Brown University
Providence, Rhode Island, United States
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Standard anti-depressant treatment with the SSRI fluoxetine
University of Texas - Southwestern Medical Center
Dallas, Texas, United States
University of Texas Medical Branch
Galveston, Texas, United States