Treatment of SSRI-Resistant Depression In Adolescents (TORDIA) (TORDIA)

March 11, 2014 updated by: University of Pittsburgh

Treatment of SSRI-Resistant Depression in Adolescents (TORDIA)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

334

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90095-6967
        • University of California at Los Angeles
    • Oregon
      • Portland, Oregon, United States, 97227-1098
        • Kaiser Permanente Center for Health Research
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • Western Psychiatric Institute and Clinic of University of Pittsburgh Medical Center
    • Rhode Island
      • Providence, Rhode Island, United States, 02906
        • Brown University
    • Texas
      • Dallas, Texas, United States, 75390-8589
        • University of Texas - Southwestern Medical Center
      • Galveston, Texas, United States, 77555-0188
        • University of Texas Medical Branch

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • Prozac
Drug: Citalopram
Standard anti-depressant treatment with the SSRI fluoxetine
Other Names:
  • 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 Names:
  • 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 Names:
  • Prozac
Drug: Citalopram
Standard anti-depressant treatment with the SSRI fluoxetine
Other Names:
  • Celexa
Behavioral: Cognitive Behavioral Therapy (CBT)
CBT addresses maladaptive beliefs in order to encourage behavioral change
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 Names:
  • Effexor XR
Behavioral: Cognitive Behavioral Therapy (CBT)
CBT addresses maladaptive beliefs in order to encourage behavioral change

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pittsburgh

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: David A. Brent, MD, Western Psychiatric Institute and Clinic (Data Coordinating Center)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2001

Primary Completion (Actual)

March 1, 2007

Study Completion (Actual)

March 1, 2007

Study Registration Dates

First Submitted

July 10, 2001

First Submitted That Met QC Criteria

July 11, 2001

First Posted (Estimate)

July 12, 2001

Study Record Updates

Last Update Posted (Estimate)

March 12, 2014

Last Update Submitted That Met QC Criteria

March 11, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • U01MH061835 (U.S. NIH Grant/Contract)
  • TORDIA
  • DSIR B4-ARD
  • MH61835

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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