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.

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Key information

Conditions

Depression Behavior Behavioral Symptoms Depressive Disorder Mental Disorders Mood Disorders

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

University of California at Los Angeles, Los Angeles, California, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fluoxetine

Drug

Standard anti-depressant treatment with the SSRI fluoxetine

Other names: Prozac

Venlafaxine

Drug

Standard antidepressant treatment with the non-SSRI medication venlafaxine

Other names: Effexor XR

Cognitive Behavioral Therapy (CBT)

Behavioral

CBT addresses maladaptive beliefs in order to encourage behavioral change

Citalopram

Drug

Standard anti-depressant treatment with the SSRI fluoxetine

Other names: Celexa

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

National Institute of Mental Health (NIMH)

Registry information

Acronym: TORDIA

Important dates

Study start: 2001
Primary completion: 2007
Study completion: 2007
First posted: Jul 12, 2001
Registry last updated: Mar 12, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed