| Home | Search | Study Topics | Glossary |
|
|
|
 |
 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||||||||||||||||||||||||||||
| Sponsored by: |
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 |
| MedlinePlus related topics: | Antidepressants Depression |
| Drug Information available for: | Fluoxetine Escitalopram Benzetimide Citalopram Citalopram hydrobromide Dexetimide Escitalopram oxalate Venlafaxine Venlafaxine hydrochloride Fluoxetine hydrochloride |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Active Control, Factorial Assignment, Efficacy Study |
| Enrollment: | 334 |
| Study Start Date: | January 2001 |
| Study Completion Date: | January 2007 |
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 |
Contacts and 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 | |||||
| Principal Investigator: | David Brent, M.D. | Western Psychiatric Institute and Clinic (Data Coordinating Center) |
More Information
Click here for more information about this study: Treatment of Resistant Depression in Adolescents
|
|
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 |
| First Received: | July 10, 2001 |
| Last Updated: | February 27, 2008 |
| ClinicalTrials.gov Identifier: | NCT00018902 |
| Health Authority: | United States: Food and Drug Administration |
|
|
|
|
|
|
