Treatment of SSRI-Resistant Depression In Adolescents (TORDIA)

Study Overview
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Brief Summary
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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
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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.

Official Title
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Treatment of SSRI-Resistant Depression in Adolescents (TORDIA)

Conditions
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Depression

Intervention / Treatment
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* Drug: Fluoxetine
* Drug: Venlafaxine
* Behavioral: Cognitive Behavioral Therapy (CBT)
* Drug: Citalopram


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Participants whose depression does not respond to an initial SSRI will switch to an alternative SSRI. | Drug: Fluoxetine<br>* Standard anti-depressant treatment with the SSRI fluoxetine<br>* Other names: Prozac;Drug: Citalopram<br>* Standard anti-depressant treatment with the SSRI fluoxetine<br>* Other names: Celexa;|
| Experimental: 2<br>Participants whose depression does not respond to an initial SSRI will switch to a different non-SSRI antidepressant. | Drug: Venlafaxine<br>* Standard antidepressant treatment with the non-SSRI medication venlafaxine<br>* Other names: Effexor XR;|
| Experimental: 3<br>Participants whose depression does not respond to an initial SSRI will switch to an alternative SSRI and receive cognitive behavioral therapy (CBT). | Drug: Fluoxetine<br>* Standard anti-depressant treatment with the SSRI fluoxetine<br>* Other names: Prozac;Behavioral: Cognitive Behavioral Therapy (CBT)<br>* CBT addresses maladaptive beliefs in order to encourage behavioral change<br>Drug: Citalopram<br>* Standard anti-depressant treatment with the SSRI fluoxetine<br>* Other names: Celexa;|
| Experimental: 4<br>Participants whose depression does not respond to an initial SSRI will switch to a different non-SSRI antidepressant and receive CBT. | Drug: Venlafaxine<br>* Standard antidepressant treatment with the non-SSRI medication venlafaxine<br>* Other names: Effexor XR;Behavioral: Cognitive Behavioral Therapy (CBT)<br>* CBT addresses maladaptive beliefs in order to encourage behavioral change<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Depressive Disorder, Adolescents, Teenagers, Teens, Cognitive Behavior Therapy