Treatment of SSRI-Resistant Depression In Adolescents (TORDIA)

Conditions

Depression

Keywords

Depressive Disorder, Adolescents, Teenagers, Teens, Cognitive Behavior Therapy

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.

Hilton RC, Rengasamy M, Mansoor B, He J, Mayes T, Emslie GJ, Porta G, Clarke GN, Wagner KD, Birmaher B, Keller MB, Ryan N, Shamseddeen W, Asarnow JR, Brent DA.

2013-04-0411 citations

10.1016/j.jaac.2013.02.013

The bi-directional relationship between parent-child conflict and treatment outcome in treatment-resistant adolescent depression.

Rengasamy M, Mansoor BM, Hilton R, Porta G, He J, Emslie GJ, Mayes T, Clarke GN, Wagner KD, Keller MB, Ryan ND, Birmaher B, Shamseddeen W, Asarnow JR, Brent DA.

2013-04-0132 citations

10.1016/j.jaac.2013.01.012

Treatment-resistant depressed youth show a higher response rate if treatment ends during summer school break.

Shamseddeen W, Clarke G, Wagner KD, Ryan ND, Birmaher B, Emslie G, Asarnow JR, Porta G, Mayes T, Keller MB, Brent DA.

2011-09-0921 citations

10.1016/j.jaac.2011.07.022

Suicide attempts and nonsuicidal self-injury in the treatment of resistant depression in adolescents: findings from the TORDIA study.

Asarnow JR, Porta G, Spirito A, Emslie G, Clarke G, Wagner KD, Vitiello B, Keller M, Birmaher B, McCracken J, Mayes T, Berk M, Brent DA.

2011-06-11380 citations

10.1016/j.jaac.2011.04.003

Pharmacokinetically and clinician-determined adherence to an antidepressant regimen and clinical outcome in the TORDIA trial.

Woldu H, Porta G, Goldstein T, Sakolsky D, Perel J, Emslie G, Mayes T, Clarke G, Ryan ND, Birmaher B, Wagner KD, Asarnow JR, Keller MB, Brent D.

2011-03-0936 citations

10.1016/j.jaac.2011.01.018

Long-term outcome of adolescent depression initially resistant to selective serotonin reuptake inhibitor treatment: a follow-up study of the TORDIA sample.

Vitiello B, Emslie G, Clarke G, Wagner KD, Asarnow JR, Keller MB, Birmaher B, Ryan ND, Kennard B, Mayes TL, DeBar L, Lynch F, Dickerson J, Strober M, Suddath R, McCracken JT, Spirito A, Onorato M, Zelazny J, Porta G, Iyengar S, Brent DA.

2011-03-0187 citations

10.4088/jcp.09m05885blu

Incremental cost-effectiveness of combined therapy vs medication only for youth with selective serotonin reuptake inhibitor-resistant depression: treatment of SSRI-resistant depression in adolescents trial findings.

Lynch FL, Dickerson JF, Clarke G, Vitiello B, Porta G, Wagner KD, Emslie G, Asarnow JR, Keller MB, Birmaher B, Ryan ND, Kennard B, Mayes T, DeBar L, McCracken JT, Strober M, Suddath RL, Spirito A, Onorato M, Zelazny J, Iyengar S, Brent D.

2011-03-0135 citations

10.1001/archgenpsychiatry.2011.9

Switching to another SSRI or to venlafaxine with or without cognitive behavioral therapy for adolescents with SSRI-resistant depression: the TORDIA randomized controlled trial.

Brent D, Emslie G, Clarke G, Wagner KD, Asarnow JR, Keller M, Vitiello B, Ritz L, Iyengar S, Abebe K, Birmaher B, Ryan N, Kennard B, Hughes C, DeBar L, McCracken J, Strober M, Suddath R, Spirito A, Leonard H, Melhem N, Porta G, Onorato M, Zelazny J.

2008-02-01377 citations

10.1001/jama.299.8.901

Interventions

DRUGFluoxetine

Standard anti-depressant treatment with the SSRI fluoxetine

DRUGVenlafaxine

Standard antidepressant treatment with the non-SSRI medication venlafaxine

BEHAVIORALCognitive Behavioral Therapy (CBT)

CBT addresses maladaptive beliefs in order to encourage behavioral change

DRUGCitalopram

Standard anti-depressant treatment with the SSRI fluoxetine

Study design

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

12 Years to 18 Years

Healthy volunteers

No

Inclusion 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

Countries

United States

Outcome results

None listed