Treatment of SSRI-Resistant Depression In Adolescents (TORDIA)

University of Pittsburgh

Status and phase: Completed; Phase 3; Phase 2

Conditions: Depression

Treatments: Drug: Citalopram; Drug: Venlafaxine; Drug: Fluoxetine; Behavioral: Cognitive Behavioral Therapy (CBT)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00018902

TORDIA

MH61835

U01MH061835 (U.S. NIH Grant/Contract)

DSIR B4-ARD

Details and patient eligibility

About

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.

Full 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.

Enrollment: 334 patients

Sex: All

Ages: 12 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Quadruple Blind

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334 participants in 4 patient groups

1

Experimental group

Description:

Participants whose depression does not respond to an initial SSRI will switch to an alternative SSRI.

Treatment:

Drug: Fluoxetine

Drug: Citalopram

2

Experimental group

Description:

Participants whose depression does not respond to an initial SSRI will switch to a different non-SSRI antidepressant.

Treatment:

Drug: Venlafaxine

3

Experimental group

Description:

Participants whose depression does not respond to an initial SSRI will switch to an alternative SSRI and receive cognitive behavioral therapy (CBT).

Treatment:

Behavioral: Cognitive Behavioral Therapy (CBT)

Drug: Fluoxetine

Drug: Citalopram

4

Experimental group

Description:

Participants whose depression does not respond to an initial SSRI will switch to a different non-SSRI antidepressant and receive CBT.

Treatment:

Behavioral: Cognitive Behavioral Therapy (CBT)

Drug: Venlafaxine