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

Primary Purpose

Depression

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Fluoxetine

Venlafaxine

Cognitive Behavioral Therapy (CBT)

Citalopram

About this trial

This is an interventional treatment trial for Depression focused on measuring Depressive Disorder, Adolescents, Teenagers, Teens, Cognitive Behavior Therapy

Eligibility Criteria

12 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of California at Los Angeles
Kaiser Permanente Center for Health Research
Western Psychiatric Institute and Clinic of University of Pittsburgh Medical Center
Brown University
University of Texas - Southwestern Medical Center
University of Texas Medical Branch

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00018902

First Posted

July 10, 2001

Last Updated

March 11, 2014

Sponsor

University of Pittsburgh

Collaborators

National Institute of Mental Health (NIMH)

1. Study Identification

Unique Protocol Identification Number

NCT00018902

Brief Title

Treatment of SSRI-Resistant Depression In Adolescents (TORDIA)

Acronym

TORDIA

Official Title

Treatment of SSRI-Resistant Depression in Adolescents (TORDIA)

Study Type

Interventional

2. Study Status

Record Verification Date

March 2014

Overall Recruitment Status

Completed

Study Start Date

January 2001 (undefined)

Primary Completion Date

March 2007 (Actual)

Study Completion Date

March 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

University of Pittsburgh

Collaborators

National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Depression

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Factorial Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

334 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

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

Arm Title

Arm Type

Experimental

Arm Description

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

Arm Title

Arm Type

Experimental

Arm Description

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

Arm Title

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Fluoxetine

Other Intervention Name(s)

Prozac

Intervention Description

Standard anti-depressant treatment with the SSRI fluoxetine

Intervention Type

Drug

Intervention Name(s)

Venlafaxine

Other Intervention Name(s)

Effexor XR

Intervention Description

Standard antidepressant treatment with the non-SSRI medication venlafaxine

Intervention Type

Behavioral

Intervention Name(s)

Cognitive Behavioral Therapy (CBT)

Intervention Description

CBT addresses maladaptive beliefs in order to encourage behavioral change

Intervention Type

Drug

Intervention Name(s)

Citalopram

Other Intervention Name(s)

Celexa

Intervention Description

Standard anti-depressant treatment with the SSRI fluoxetine

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

David A. Brent, MD

Organizational Affiliation

Western Psychiatric Institute and Clinic (Data Coordinating Center)

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of California at Los Angeles

City

Los Angeles

State/Province

California

ZIP/Postal Code

90095-6967

Country

United States

Facility Name

Kaiser Permanente Center for Health Research

City

Portland

State/Province

Oregon

ZIP/Postal Code

97227-1098

Country

United States

Facility Name

Western Psychiatric Institute and Clinic of University of Pittsburgh Medical Center

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15213

Country

United States

Facility Name

Brown University

City

Providence

State/Province

Rhode Island

ZIP/Postal Code

02906

Country

United States

Facility Name

University of Texas - Southwestern Medical Center

City

Dallas

State/Province

Texas

ZIP/Postal Code

75390-8589

Country

United States

Facility Name

University of Texas Medical Branch

City

Galveston

State/Province

Texas

ZIP/Postal Code

77555-0188

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

9294380

Citation

Brent DA, Holder D, Kolko D, Birmaher B, Baugher M, Roth C, Iyengar S, Johnson BA. A clinical psychotherapy trial for adolescent depression comparing cognitive, family, and supportive therapy. Arch Gen Psychiatry. 1997 Sep;54(9):877-85. doi: 10.1001/archpsyc.1997.01830210125017.

Results Reference

background

PubMed Identifier

9366660

Citation

Emslie GJ, Rush AJ, Weinberg WA, Kowatch RA, Hughes CW, Carmody T, Rintelmann J. A double-blind, randomized, placebo-controlled trial of fluoxetine in children and adolescents with depression. Arch Gen Psychiatry. 1997 Nov;54(11):1031-7. doi: 10.1001/archpsyc.1997.01830230069010.

Results Reference

background

Citation

Keller MB, Ryan ND, Birmaher B, Klein RG, Strober M, Wagner KD, Weller EB: Paroxetine and imipramine in the treatment of adolescent depression. New Research Program Abstracts. Annual Meeting of the American Psychiatric Association [123], 1998.

Results Reference

background

PubMed Identifier

22251022

Citation

Wagner KD, Asarnow JR, Vitiello B, Clarke G, Keller M, Emslie GJ, Ryan N, Porta G, Iyengar S, Ritz L, Zelanzny J, Onorato M, Brent D. Out of the black box: treatment of resistant depression in adolescents and the antidepressant controversy. J Child Adolesc Psychopharmacol. 2012 Feb;22(1):5-10. doi: 10.1089/cap.2011.0045. Epub 2012 Jan 17. Erratum In: J Child Adolesc Psychopharmacol. 2019 Aug;29(7):574.

Results Reference

background

PubMed Identifier

18314433

Citation

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. Switching to another SSRI or to venlafaxine with or without cognitive behavioral therapy for adolescents with SSRI-resistant depression: the TORDIA randomized controlled trial. JAMA. 2008 Feb 27;299(8):901-913. doi: 10.1001/jama.299.8.901. Erratum In: JAMA. 2019 Nov 5;322(17):1718.

Results Reference

result

PubMed Identifier

19223438

Citation

Brent DA, Emslie GJ, Clarke GN, Asarnow J, Spirito A, Ritz L, Vitiello B, Iyengar S, Birmaher B, Ryan ND, Zelazny J, Onorato M, Kennard B, Mayes TL, Debar LL, McCracken JT, Strober M, Suddath R, Leonard H, Porta G, Keller MB. Predictors of spontaneous and systematically assessed suicidal adverse events in the treatment of SSRI-resistant depression in adolescents (TORDIA) study. Am J Psychiatry. 2009 Apr;166(4):418-26. doi: 10.1176/appi.ajp.2008.08070976. Epub 2009 Feb 17. Erratum In: Am J Psychiatry. 2019 Sep 1;176(9):764.

Results Reference

result

PubMed Identifier

19182688

Citation

Asarnow JR, Emslie G, Clarke G, Wagner KD, Spirito A, Vitiello B, Iyengar S, Shamseddeen W, Ritz L, Birmaher B, Ryan N, Kennard B, Mayes T, DeBar L, McCracken J, Strober M, Suddath R, Leonard H, Porta G, Keller M, Brent D. Treatment of selective serotonin reuptake inhibitor-resistant depression in adolescents: predictors and moderators of treatment response. J Am Acad Child Adolesc Psychiatry. 2009 Mar;48(3):330-339. doi: 10.1097/chi.0b013e3181977476.

Results Reference

result

PubMed Identifier

19858762

Citation

Goldstein BI, Shamseddeen W, Spirito A, Emslie G, Clarke G, Wagner KD, Asarnow JR, Vitiello B, Ryan N, Birmaher B, Mayes T, Onorato M, Zelazny J, Brent DA. Substance use and the treatment of resistant depression in adolescents. J Am Acad Child Adolesc Psychiatry. 2009 Dec;48(12):1182-92. doi: 10.1097/CHI.0b013e3181bef6e8.

Results Reference

result

PubMed Identifier

19485586

Citation

Spirito A, Abebe KZ, Iyengar S, Brent D, Vitiello B, Clarke G, Wagner KD, Asarnow J, Emslie G, Keller M. Sources of site differences in the efficacy of a multisite clinical trial: the Treatment of SSRI-Resistant Depression in Adolescents. J Consult Clin Psychol. 2009 Jun;77(3):439-50. doi: 10.1037/a0014834.

Results Reference

result

PubMed Identifier

19968380

Citation

Kennard BD, Clarke GN, Weersing VR, Asarnow JR, Shamseddeen W, Porta G, Berk M, Hughes JL, Spirito A, Emslie GJ, Keller MB, Wagner KD, Brent DA. Effective components of TORDIA cognitive-behavioral therapy for adolescent depression: preliminary findings. J Consult Clin Psychol. 2009 Dec;77(6):1033-41. doi: 10.1037/a0017411.

Results Reference

result

PubMed Identifier

20008943

Citation

Brent D, Melhem N, Ferrell R, Emslie G, Wagner KD, Ryan N, Vitiello B, Birmaher B, Mayes T, Zelazny J, Onorato M, Devlin B, Clarke G, DeBar L, Keller M. Association of FKBP5 polymorphisms with suicidal events in the Treatment of Resistant Depression in Adolescents (TORDIA) study. Am J Psychiatry. 2010 Feb;167(2):190-7. doi: 10.1176/appi.ajp.2009.09040576. Epub 2009 Dec 15.

Results Reference

result

PubMed Identifier

20478877

Citation

Emslie GJ, Mayes T, Porta G, Vitiello B, Clarke G, Wagner KD, Asarnow JR, Spirito A, Birmaher B, Ryan N, Kennard B, DeBar L, McCracken J, Strober M, Onorato M, Zelazny J, Keller M, Iyengar S, Brent D. Treatment of Resistant Depression in Adolescents (TORDIA): week 24 outcomes. Am J Psychiatry. 2010 Jul;167(7):782-91. doi: 10.1176/appi.ajp.2010.09040552. Epub 2010 May 17.

Results Reference

result

PubMed Identifier

21784297

Citation

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. Suicide attempts and nonsuicidal self-injury in the treatment of resistant depression in adolescents: findings from the TORDIA study. J Am Acad Child Adolesc Psychiatry. 2011 Aug;50(8):772-81. doi: 10.1016/j.jaac.2011.04.003. Epub 2011 Jun 11.

Results Reference

result

PubMed Identifier

21192150

Citation

Sakolsky DJ, Perel JM, Emslie GJ, Clarke GN, Wagner KD, Vitiello B, Keller MB, Birmaher B, Asarnow JR, Ryan ND, McCracken JT, Strober MJ, Iyengar S, Porta G, Brent DA. Antidepressant exposure as a predictor of clinical outcomes in the Treatment of Resistant Depression in Adolescents (TORDIA) study. J Clin Psychopharmacol. 2011 Feb;31(1):92-7. doi: 10.1097/JCP.0b013e318204b117.

Results Reference

result

PubMed Identifier

21334569

Citation

Shamseddeen W, Asarnow JR, Clarke G, Vitiello B, Wagner KD, Birmaher B, Keller MB, Emslie G, Iyengar S, Ryan ND, McCracken JT, Porta G, Mayes T, Brent DA. Impact of physical and sexual abuse on treatment response in the Treatment of Resistant Depression in Adolescent Study (TORDIA). J Am Acad Child Adolesc Psychiatry. 2011 Mar;50(3):293-301. doi: 10.1016/j.jaac.2010.11.019. Epub 2011 Jan 14. Erratum In: J Am Acad Child Adolesc Psychiatry. 2020 Mar;59(3):454-463.

Results Reference

result

PubMed Identifier

21208583

Citation

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. Long-term outcome of adolescent depression initially resistant to selective serotonin reuptake inhibitor treatment: a follow-up study of the TORDIA sample. J Clin Psychiatry. 2011 Mar;72(3):388-96. doi: 10.4088/JCP.09m05885blu. Erratum In: J Clin Psychiatry. 2019 Oct 23;80(5):

Results Reference

result

PubMed Identifier

21515198

Citation

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. Pharmacokinetically and clinician-determined adherence to an antidepressant regimen and clinical outcome in the TORDIA trial. J Am Acad Child Adolesc Psychiatry. 2011 May;50(5):490-8. doi: 10.1016/j.jaac.2011.01.018. Epub 2011 Mar 9.

Results Reference

result

PubMed Identifier

22284022

Citation

Maalouf FT, Porta G, Vitiello B, Emslie G, Mayes T, Clarke G, Wagner KD, Asarnow JR, Spirito A, Keller M, Birmaher B, Ryan N, Shamseddeen W, Iyengar S, Brent D. Do sub-syndromal manic symptoms influence outcome in treatment resistant depression in adolescents? A latent class analysis from the TORDIA study. J Affect Disord. 2012 Apr;138(1-2):86-95. doi: 10.1016/j.jad.2011.12.021. Epub 2012 Jan 30. Erratum In: J Affect Disord. 2019 Nov 1;258:55.

Results Reference

result

PubMed Identifier

21383263

Citation

Lynch FL, Dickerson JF, Clarke G, Vitiello B, Porta G, Wagner KD, Emslie G, Asarnow JR 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. 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. Arch Gen Psychiatry. 2011 Mar;68(3):253-62. doi: 10.1001/archgenpsychiatry.2011.9.

Results Reference

result

PubMed Identifier

22024002

Citation

Shamseddeen W, Clarke G, Wagner KD, Ryan ND, Birmaher B, Emslie G, Asarnow JR, Porta G, Mayes T, Keller MB, Brent DA. Treatment-resistant depressed youth show a higher response rate if treatment ends during summer school break. J Am Acad Child Adolesc Psychiatry. 2011 Nov;50(11):1140-8. doi: 10.1016/j.jaac.2011.07.022. Epub 2011 Sep 9.

Results Reference

result

PubMed Identifier

22251024

Citation

Shamseddeen W, Clarke G, Keller MB, Wagner KD, Birmaher B, Emslie GJ, Ryan N, Asarnow JR, Porta G, Brent DA. Adjunctive sleep medications and depression outcome in the treatment of serotonin-selective reuptake inhibitor resistant depression in adolescents study. J Child Adolesc Psychopharmacol. 2012 Feb;22(1):29-36. doi: 10.1089/cap.2011.0027. Epub 2012 Jan 17. Erratum In: J Child Adolesc Psychopharmacol. 2019 Aug;29(7):573.

Results Reference

result

PubMed Identifier

22449646

Citation

McMakin DL, Olino TM, Porta G, Dietz LJ, Emslie G, Clarke G, Wagner KD, Asarnow JR, Ryan ND, Birmaher B, Shamseddeen W, Mayes T, Kennard B, Spirito A, Keller M, Lynch FL, Dickerson JF, Brent DA. Anhedonia predicts poorer recovery among youth with selective serotonin reuptake inhibitor treatment-resistant depression. J Am Acad Child Adolesc Psychiatry. 2012 Apr;51(4):404-11. doi: 10.1016/j.jaac.2012.01.011. Epub 2012 Mar 3.

Results Reference

result

PubMed Identifier

23582868

Citation

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. The bi-directional relationship between parent-child conflict and treatment outcome in treatment-resistant adolescent depression. J Am Acad Child Adolesc Psychiatry. 2013 Apr;52(4):370-7. doi: 10.1016/j.jaac.2013.01.012.

Results Reference

result

PubMed Identifier

23622849

Citation

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. Impact of treatments for depression on comorbid anxiety, attentional, and behavioral symptoms in adolescents with selective serotonin reuptake inhibitor-resistant depression. J Am Acad Child Adolesc Psychiatry. 2013 May;52(5):482-92. doi: 10.1016/j.jaac.2013.02.013. Epub 2013 Apr 4.

Results Reference

result

PubMed Identifier

24024532

Citation

Mansoor B, Rengasamy M, Hilton R, Porta G, He J, Spirito A, Emslie GJ, Mayes TL, Clarke G, Wagner KD, Shamseddeen W, Birmaher B, Ryan N, Brent D. The bidirectional relationship between body mass index and treatment outcome in adolescents with treatment-resistant depression. J Child Adolesc Psychopharmacol. 2013 Sep;23(7):458-67. doi: 10.1089/cap.2012.0095. Epub 2013 Sep 11.

Results Reference

result

PubMed Identifier

23975354

Citation

Perloe A, Esposito-Smythers C, Curby TW, Renshaw KD. Concurrent trajectories of change in adolescent and maternal depressive symptoms in the TORDIA study. J Youth Adolesc. 2014 Apr;43(4):612-28. doi: 10.1007/s10964-013-9999-0. Epub 2013 Aug 22.

Results Reference

derived

Links:

URL

http://www.ncbi.nlm.nih.gov/pubmed/19223438?ordinalpos=6&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_DefaultReportPanel.Pubmed_RVDocSum

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Treatment of SSRI-Resistant Depression In Adolescents (TORDIA)

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