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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

July 10, 2001
March 11, 2014
January 2001
March 2007   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00018902 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Treatment of SSRI-Resistant Depression In Adolescents (TORDIA)
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.

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.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Depression
  • Drug: Fluoxetine
    Standard anti-depressant treatment with the SSRI fluoxetine
    Other Name: Prozac
  • 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
  • Drug: Citalopram
    Standard anti-depressant treatment with the SSRI fluoxetine
    Other Name: Celexa
  • Experimental: 1
    Participants whose depression does not respond to an initial SSRI will switch to an alternative SSRI.
    Interventions:
    • Drug: Fluoxetine
    • Drug: Citalopram
  • Experimental: 2
    Participants whose depression does not respond to an initial SSRI will switch to a different non-SSRI antidepressant.
    Intervention: Drug: Venlafaxine
  • Experimental: 3
    Participants whose depression does not respond to an initial SSRI will switch to an alternative SSRI and receive cognitive behavioral therapy (CBT).
    Interventions:
    • Drug: Fluoxetine
    • Behavioral: Cognitive Behavioral Therapy (CBT)
    • Drug: Citalopram
  • Experimental: 4
    Participants whose depression does not respond to an initial SSRI will switch to a different non-SSRI antidepressant and receive CBT.
    Interventions:
    • Drug: Venlafaxine
    • Behavioral: Cognitive Behavioral Therapy (CBT)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
334
March 2007
March 2007   (final data collection date for primary outcome measure)
  • 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
Both
12 Years to 18 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00018902
U01 MH61835, U01MH061835, TORDIA, DSIR B4-ARD, MH61835
Yes
David A. Brent, MD, Western Psychiatric Institute and Clinic (Data Coordinating Center)
University of Pittsburgh
National Institute of Mental Health (NIMH)
Principal Investigator: David A. Brent, MD Western Psychiatric Institute and Clinic (Data Coordinating Center)
University of Pittsburgh
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP