Treatment of SSRI-Resistant Depression In Adolescents (TORDIA)

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00018902
First received: July 10, 2001
Last updated: March 11, 2014
Last verified: March 2014
  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
Drug: Venlafaxine
Behavioral: Cognitive Behavioral Therapy (CBT)
Drug: Citalopram
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treatment of SSRI-Resistant Depression in Adolescents (TORDIA)

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Enrollment: 334
Study Start Date: January 2001
Study Completion Date: March 2007
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Participants whose depression does not respond to an initial SSRI will switch to an alternative SSRI.
Drug: Fluoxetine
Standard anti-depressant treatment with the SSRI fluoxetine
Other Name: Prozac
Drug: Citalopram
Standard anti-depressant treatment with the SSRI fluoxetine
Other Name: Celexa
Experimental: 2
Participants whose depression does not respond to an initial SSRI will switch to a different non-SSRI antidepressant.
Drug: Venlafaxine
Standard antidepressant treatment with the non-SSRI medication venlafaxine
Other Name: Effexor XR
Experimental: 3
Participants whose depression does not respond to an initial SSRI will switch to an alternative SSRI and receive cognitive behavioral therapy (CBT).
Drug: Fluoxetine
Standard anti-depressant treatment with the SSRI fluoxetine
Other Name: Prozac
Behavioral: Cognitive Behavioral Therapy (CBT)
CBT addresses maladaptive beliefs in order to encourage behavioral change
Drug: Citalopram
Standard anti-depressant treatment with the SSRI fluoxetine
Other Name: Celexa
Experimental: 4
Participants whose depression does not respond to an initial SSRI will switch to a different non-SSRI antidepressant and receive CBT.
Drug: Venlafaxine
Standard antidepressant treatment with the non-SSRI medication venlafaxine
Other Name: Effexor XR
Behavioral: Cognitive Behavioral Therapy (CBT)
CBT addresses maladaptive beliefs in order to encourage behavioral change

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.

  Eligibility

Ages Eligible for Study:   12 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00018902

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 - Southwestern Medical Center
Dallas, Texas, United States, 75390-8589
University of Texas Medical Branch
Galveston, Texas, United States, 77555-0188
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: David A. Brent, MD Western Psychiatric Institute and Clinic (Data Coordinating Center)
  More Information

Additional Information:
Publications:
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.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: David A. Brent, MD, Western Psychiatric Institute and Clinic (Data Coordinating Center)
ClinicalTrials.gov Identifier: NCT00018902     History of Changes
Other Study ID Numbers: U01 MH61835, U01MH061835, TORDIA, DSIR B4-ARD, MH61835
Study First Received: July 10, 2001
Last Updated: March 11, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Pittsburgh:
Depressive Disorder
Adolescents
Teenagers
Teens
Cognitive Behavior Therapy

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Venlafaxine
Fluoxetine
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 30, 2014