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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00018902
Recruitment Status : Completed
First Posted : July 12, 2001
Last Update Posted : March 12, 2014
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by:
University of Pittsburgh

Tracking Information
First Submitted Date  ICMJE July 10, 2001
First Posted Date  ICMJE July 12, 2001
Last Update Posted Date March 12, 2014
Study Start Date  ICMJE January 2001
Actual Primary Completion Date March 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00018902 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Treatment of SSRI-Resistant Depression In Adolescents (TORDIA)
Official Title  ICMJE Treatment of SSRI-Resistant Depression in Adolescents (TORDIA)
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Depression
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 13, 2007)
334
Original Enrollment  ICMJE
 (submitted: June 23, 2005)
400
Actual Study Completion Date  ICMJE March 2007
Actual Primary Completion Date March 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE
  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00018902
Other Study ID Numbers  ICMJE U01MH061835( U.S. NIH Grant/Contract )
U01MH061835 ( U.S. NIH Grant/Contract )
TORDIA
DSIR B4-ARD
MH61835
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party David A. Brent, MD, Western Psychiatric Institute and Clinic (Data Coordinating Center)
Study Sponsor  ICMJE University of Pittsburgh
Collaborators  ICMJE National Institute of Mental Health (NIMH)
Investigators  ICMJE
Principal Investigator: David A. Brent, MD Western Psychiatric Institute and Clinic (Data Coordinating Center)
PRS Account University of Pittsburgh
Verification Date March 2014

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