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DepressionPhase 2/3TORDIANCT00018902

Treatment of SSRI-Resistant Depression In Adolescents (TORDIA)

A Phase 2/3 study testing Fluoxetine, Venlafaxine and Cognitive Behavioral Therapy (CBT) in people with Depression, run by University of Pittsburgh at 6 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 12 to 18 years
Conditions the study is for
Depression
What is being tested?
Fluoxetine, Venlafaxine and Cognitive Behavioral Therapy (CBT)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
334 participants
Where
6 sitesUnited States
Study dates
Jan 2001to Mar 2007
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult
  • 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 locations and contacts

6 sites in 1 country.

6 sites in 1 country

United States6 sites

  • University of Texas - Southwestern Medical Center

    Dallas, Texas, 75390-8589

  • University of Texas Medical Branch

    Galveston, Texas, 77555-0188

  • University of California at Los Angeles

    Los Angeles, California, 90095-6967

  • Western Psychiatric Institute and Clinic of University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15213

  • Kaiser Permanente Center for Health Research

    Portland, Oregon, 97227-1098

  • Brown University

    Providence, Rhode Island, 02906

Other trials in United States

About this study

Official title: 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.

Read the 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.

Conditions
Depression
Being tested
Fluoxetine, Venlafaxine, Cognitive Behavioral Therapy (CBT), Citalopram
Keywords
Depressive Disorder, Adolescents, Teenagers, Teens, Cognitive Behavior Therapy
Medical subject headings
Depression, Depressive Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FluoxetineDrug

    Also called Prozac

    Standard anti-depressant treatment with the SSRI fluoxetine

  • VenlafaxineDrug

    Also called Effexor XR

    Standard antidepressant treatment with the non-SSRI medication venlafaxine

  • Cognitive Behavioral Therapy (CBT)Behavioural

    CBT addresses maladaptive beliefs in order to encourage behavioral change

  • CitalopramDrug

    Also called Celexa

    Standard anti-depressant treatment with the SSRI fluoxetine

Study groups in NCT00018902
Study groupRoleWhat they receive
1ExperimentalParticipants whose depression does not respond to an initial SSRI will switch to an alternative SSRI.
Receives: Drug: Fluoxetine; Drug: Citalopram
2ExperimentalParticipants whose depression does not respond to an initial SSRI will switch to a different non-SSRI antidepressant.
Receives: Drug: Venlafaxine
3ExperimentalParticipants whose depression does not respond to an initial SSRI will switch to an alternative SSRI and receive cognitive behavioral therapy (CBT).
Receives: Drug: Fluoxetine; Behavioral: Cognitive Behavioral Therapy (CBT); Drug: Citalopram
4ExperimentalParticipants whose depression does not respond to an initial SSRI will switch to a different non-SSRI antidepressant and receive CBT.
Receives: Drug: Venlafaxine; Behavioral: Cognitive Behavioral Therapy (CBT)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jul 2001 (estimated)
  2. Study startJan 2001
  3. Primary completionMar 2007
  4. Study completionMar 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Factorial
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
334 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00018902
Sponsor's protocol ID
U01MH061835
Other IDs
U01MH061835, TORDIA, DSIR B4-ARD, MH61835
Acronym
TORDIA
Status last verified
Mar 2014
First submitted
10 Jul 2001
Last updated
12 Mar 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 9294380

  • 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.

    PubMed 9366660

  • 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.

  • 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.

    PubMed 22251022

  • 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.

    PubMed 18314433

  • 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.

    PubMed 19223438

  • 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.

    PubMed 19182688

  • 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.

    PubMed 19858762

  • 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.

    PubMed 19485586

  • 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.

    PubMed 19968380

  • 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.

    PubMed 20008943

  • 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.

    PubMed 20478877

  • 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.

    PubMed 21784297

  • 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.

    PubMed 21192150

  • 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.

    PubMed 21334569

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Fluoxetine, Venlafaxine and Cognitive Behavioral Therapy (CBT) in people with Depression, run by University of Pittsburgh at 6 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00018902, which also lists 26 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2014.

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