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

Home

Study Topics

Glossary


	Full Text View


	Tabular View


	Contacts and Locations


	Related Studies

Treatment of SSRI-Resistant Depression In Adolescents (TORDIA)

This study has been completed.
Information provided by National Institute of Mental Health (NIMH)

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

Treatment of SSRI-Resistant Depression In Adolescents (TORDIA)

Official Title ^†

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 Phase

Phase II, Phase III

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Double-Blind, Active Control, Factorial Assignment, Efficacy Study

Primary Outcome Measure ^†

Secondary Outcome Measure ^†

Condition ^†

Depression

Intervention ^†

Drug: fluoxetine (Prozac)
Drug: venlafaxine (Effexor XR)
Procedure: Cognitive Behavioral Therapy (CBT)
Drug: citalopram (Celexa)

MEDLINE PMIDs

18314433, 9294380, 9366660

Links

Click here for more information about this study: Treatment of Resistant Depression in Adolescents This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

Recruitment Information Fields

Recruitment Status ^†

Completed

Enrollment ^†

334

Start Date ^†

January 2001

Completion Date

January 2007

Eligibility 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

Gender

Both

Ages

12 Years to 18 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States

Administrative Information Fields

NCT ID ^†

NCT00018902

Organization ID

U01 MH61835

Secondary IDs ^††

TORDIA, DSIR B4-ARD

Study Sponsor ^†

National Institute of Mental Health (NIMH)

Collaborators ^††

Investigators ^†

Principal Investigator:

David Brent, M.D.

Western Psychiatric Institute and Clinic (Data Coordinating Center)

Information Provided By

National Institute of Mental Health (NIMH)

Verification Date

February 2008

First Received Date ^†

July 10, 2001

Last Updated Date

February 27, 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.