Treatment of SSRI-Resistant Depression In Adolescents (TORDIA)
- Conditions
- Depression
- Interventions
- Registration Number
- NCT00018902
- Lead Sponsor
- University of Pittsburgh
- Brief Summary
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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 334
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description 3 Fluoxetine Participants whose depression does not respond to an initial SSRI will switch to an alternative SSRI and receive cognitive behavioral therapy (CBT). 3 Cognitive Behavioral Therapy (CBT) Participants whose depression does not respond to an initial SSRI will switch to an alternative SSRI and receive cognitive behavioral therapy (CBT). 4 Cognitive Behavioral Therapy (CBT) Participants whose depression does not respond to an initial SSRI will switch to a different non-SSRI antidepressant and receive CBT. 1 Fluoxetine Participants whose depression does not respond to an initial SSRI will switch to an alternative SSRI. 1 Citalopram Participants whose depression does not respond to an initial SSRI will switch to an alternative SSRI. 2 Venlafaxine Participants whose depression does not respond to an initial SSRI will switch to a different non-SSRI antidepressant. 3 Citalopram Participants whose depression does not respond to an initial SSRI will switch to an alternative SSRI and receive cognitive behavioral therapy (CBT). 4 Venlafaxine Participants whose depression does not respond to an initial SSRI will switch to a different non-SSRI antidepressant and receive CBT.
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (6)
Kaiser Permanente Center for Health Research
🇺🇸Portland, Oregon, United States
University of California at Los Angeles
🇺🇸Los Angeles, California, United States
Brown University
🇺🇸Providence, Rhode Island, United States
University of Texas - Southwestern Medical Center
🇺🇸Dallas, Texas, United States
Western Psychiatric Institute and Clinic of University of Pittsburgh Medical Center
🇺🇸Pittsburgh, Pennsylvania, United States
University of Texas Medical Branch
🇺🇸Galveston, Texas, United States