NCT00006286

Brief Summary

TADS is designed to compare the effectiveness of established treatments for teenagers suffering from major depressive disorder (MDD). The treatments are: psychotherapy ("talking therapy"); medication; and the combination of psychotherapy and medication. Altogether, 432 teenagers (both males and females) ages 12 to 17, will take part in this study at 12 sites in the United States. The TADS design will provide answers to the following questions: What is the long-term effectiveness of medication treatment of teenagers who have major depression? What is the long-term effectiveness of a specific psychotherapy ("talking therapy) in the treatment of teenagers who have major depression? How does medication treatment compare with psychotherapy in terms of effectiveness, tolerability and teenager and family acceptance? And, What is the cost-effectiveness of medication, psychotherapy and combined treatments? The medication being used in this study is called fluoxetine. Fluoxetine is also known as Prozac. Research has shown that medications like Prozac help depression in young persons. Fluoxetine has been approved by the FDA for use in the treatment of child and adolescent (ages 7 to 17 years) depression. The psychotherapy or "talking therapy" being used in this study is called Cognitive Behavioral Therapy (CBT). CBT is a talking therapy that will teach both the teenager and his or her family member (e.g., parent) new skills to cope better with depression. Specific topics include education about depression and the causes of depression, setting goals, monitoring mood, increasing pleasant activities, social problem-solving, correcting negative thinking, negotiation, compromise and assertiveness. CBT sessions may also help with resolving disagreements as they affect families.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
432

participants targeted

Target at P50-P75 for phase_3 major-depressive-disorder

Timeline
Completed

Started Sep 1998

Longer than P75 for phase_3 major-depressive-disorder

Geographic Reach
1 country

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 1998

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

September 14, 2000

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 15, 2000

Completed
3.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2004

Completed
Last Updated

April 17, 2014

Status Verified

November 1, 2005

First QC Date

September 14, 2000

Last Update Submit

April 16, 2014

Conditions

Major Depressive DisorderDepression

Keywords

DepressionMajor Depressive DisorderFluoxetineProzacSSRIPsychotherapyCBTTeenagersAdolescentsTeens

Interventions

FluoxetineDRUG
PsychotherapyBEHAVIORAL

Eligibility Criteria

Age12 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Primary diagnosis DSM-IV of Major Depressive Disorder, pervasive and stable; Children's Depression Rating Scale-R total score at least 45; Ages 12-17 inclusive; Grade in school: 6-12; Full-Scale IQ at least 80; Medication-free before start of study; Outpatient; Parent (or family member) involvement

You may not qualify if:

  • Bipolar disorder; Severe Conduct Disorder; Substance Use/Abuse/Dependence; Pervasive Developmental Disorders; Thought Disorder; Suicidality or homicidality; Concurrent treatment with psychotropic drug (stable stimulant for ADHD permitted) or psychotherapy outside study; Two previous failed SSRI trials or a failed trial of CBT for depression; Intolerance to fluoxetine; Non-English speaking patient; Pregnancy or breastfeeding; No phone in home; Lack of parent or family member)involvement.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Northwestern University

Chicago, Illinois, 60611, United States

Location

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Wayne State University

Detroit, Michigan, 48207, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 68198-5581, United States

Location

New York University Medical Center

New York, New York, 10016, United States

Location

New York State Psychiatric Institute

New York, New York, 10032, United States

Location

Behavioral Health Center

Charlotte, North Carolina, 28203, United States

Location

Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Case Western Reserve University

Cleveland, Ohio, 44106, United States

Location

University of Oregon

Eugene, Oregon, 97403, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

University of Texas Southwestern Medical Center at Dallas

Dallas, Texas, 75235, United States

Location

Related Publications (25)

  • Glass RM. Treatment of adolescents with major depression: contributions of a major trial. JAMA. 2004 Aug 18;292(7):861-3. doi: 10.1001/jama.292.7.861. No abstract available.

    PMID: 15316001BACKGROUND

  • Treatment for Adolescents With Depression Study Team. Treatment for Adolescents With Depression Study (TADS): rationale, design, and methods. J Am Acad Child Adolesc Psychiatry. 2003 May;42(5):531-42. doi: 10.1097/01.CHI.0000046839.90931.0D.

    PMID: 12707557BACKGROUND

  • March J, Silva S, Petrycki S, Curry J, Wells K, Fairbank J, Burns B, Domino M, McNulty S, Vitiello B, Severe J; Treatment for Adolescents With Depression Study (TADS) Team. Fluoxetine, cognitive-behavioral therapy, and their combination for adolescents with depression: Treatment for Adolescents With Depression Study (TADS) randomized controlled trial. JAMA. 2004 Aug 18;292(7):807-20. doi: 10.1001/jama.292.7.807.

    PMID: 15315995RESULT

  • Treatment for Adolescents with Depression Study (TADS) Team. The Treatment for Adolescents With Depression Study (TADS): demographic and clinical characteristics. J Am Acad Child Adolesc Psychiatry. 2005 Jan;44(1):28-40. doi: 10.1097/01.chi.0000145807.09027.82.

    PMID: 15608541RESULT

  • March J, Silva S, Vitiello B; TADS Team. The Treatment for Adolescents with Depression Study (TADS): methods and message at 12 weeks. J Am Acad Child Adolesc Psychiatry. 2006 Dec;45(12):1393-403. doi: 10.1097/01.chi.0000237709.35637.c0.

    PMID: 17135984RESULT

  • Emslie G, Kratochvil C, Vitiello B, Silva S, Mayes T, McNulty S, Weller E, Waslick B, Casat C, Walkup J, Pathak S, Rohde P, Posner K, March J; Columbia Suicidality Classification Group; TADS Team. Treatment for Adolescents with Depression Study (TADS): safety results. J Am Acad Child Adolesc Psychiatry. 2006 Dec;45(12):1440-55. doi: 10.1097/01.chi.0000240840.63737.1d.

    PMID: 17135989RESULT

  • Curry J, Rohde P, Simons A, Silva S, Vitiello B, Kratochvil C, Reinecke M, Feeny N, Wells K, Pathak S, Weller E, Rosenberg D, Kennard B, Robins M, Ginsburg G, March J; TADS Team. Predictors and moderators of acute outcome in the Treatment for Adolescents with Depression Study (TADS). J Am Acad Child Adolesc Psychiatry. 2006 Dec;45(12):1427-39. doi: 10.1097/01.chi.0000240838.78984.e2.

    PMID: 17135988RESULT

  • Kratochvil C, Emslie G, Silva S, McNulty S, Walkup J, Curry J, Reinecke M, Vitiello B, Rohde P, Feeny N, Casat C, Pathak S, Weller E, May D, Mayes T, Robins M, March J; TADS Team. Acute time to response in the Treatment for Adolescents with Depression Study (TADS). J Am Acad Child Adolesc Psychiatry. 2006 Dec;45(12):1412-8. doi: 10.1097/01.chi.0000237710.73755.14.

    PMID: 17135986RESULT

  • Kennard B, Silva S, Vitiello B, Curry J, Kratochvil C, Simons A, Hughes J, Feeny N, Weller E, Sweeney M, Reinecke M, Pathak S, Ginsburg G, Emslie G, March J; TADS Team. Remission and residual symptoms after short-term treatment in the Treatment of Adolescents with Depression Study (TADS). J Am Acad Child Adolesc Psychiatry. 2006 Dec;45(12):1404-11. doi: 10.1097/01.chi.0000242228.75516.21.

    PMID: 17135985RESULT

  • Vitiello B, Rohde P, Silva S, Wells K, Casat C, Waslick B, Simons A, Reinecke M, Weller E, Kratochvil C, Walkup J, Pathak S, Robins M, March J; TADS Team. Functioning and quality of life in the Treatment for Adolescents with Depression Study (TADS). J Am Acad Child Adolesc Psychiatry. 2006 Dec;45(12):1419-26. doi: 10.1097/01.chi.0000242229.52646.6e.

    PMID: 17135987RESULT

  • March JS, Silva S, Petrycki S, Curry J, Wells K, Fairbank J, Burns B, Domino M, McNulty S, Vitiello B, Severe J. The Treatment for Adolescents With Depression Study (TADS): long-term effectiveness and safety outcomes. Arch Gen Psychiatry. 2007 Oct;64(10):1132-43. doi: 10.1001/archpsyc.64.10.1132.

    PMID: 17909125RESULT

  • Herman KC, Ostrander R, Walkup JT, Silva SG, March JS. Empirically derived subtypes of adolescent depression: latent profile analysis of co-occurring symptoms in the Treatment for Adolescents with Depression Study (TADS). J Consult Clin Psychol. 2007 Oct;75(5):716-28. doi: 10.1037/0022-006X.75.5.716.

    PMID: 17907854RESULT

  • Jureidini J, Moncrieff J, Klau J, Aboustate N, Raven M. Treatment guesses in the Treatment for Adolescents with Depression Study: Accuracy, unblinding and influence on outcomes. Aust N Z J Psychiatry. 2024 Apr;58(4):355-364. doi: 10.1177/00048674231218623. Epub 2023 Dec 21.

    PMID: 38126083DERIVED

  • Baumgartner N, Foster S, Emery S, Berger G, Walitza S, Haberling I. How Are Discrepant Parent-Child Reports Integrated? A Case of Depressed Adolescents. J Child Adolesc Psychopharmacol. 2021 May;31(4):279-287. doi: 10.1089/cap.2020.0116. Epub 2020 Dec 29.

    PMID: 33373537DERIVED

  • Wang B, Ogburn EL, Rosenblum M. Analysis of covariance in randomized trials: More precision and valid confidence intervals, without model assumptions. Biometrics. 2019 Dec;75(4):1391-1400. doi: 10.1111/biom.13062. Epub 2019 Jun 3.

    PMID: 31009064DERIVED

  • Foster S, Mohler-Kuo M, Tay L, Hothorn T, Seibold H. Estimating patient-specific treatment advantages in the 'Treatment for Adolescents with Depression Study'. J Psychiatr Res. 2019 May;112:61-70. doi: 10.1016/j.jpsychires.2019.02.021. Epub 2019 Feb 28.

    PMID: 30856378DERIVED

  • Scott K, Lewis CC, Marti CN. Trajectories of Symptom Change in the Treatment for Adolescents With Depression Study. J Am Acad Child Adolesc Psychiatry. 2019 Mar;58(3):319-328. doi: 10.1016/j.jaac.2018.07.908. Epub 2019 Jan 8.

    PMID: 30768414DERIVED

  • Foster S, Mohler-Kuo M. Treating a broader range of depressed adolescents with combined therapy. J Affect Disord. 2018 Dec 1;241:417-424. doi: 10.1016/j.jad.2018.08.027. Epub 2018 Aug 12.

    PMID: 30145512DERIVED

  • Lewis CC, Simons AD, Nguyen LJ, Murakami JL, Reid MW, Silva SG, March JS. Impact of childhood trauma on treatment outcome in the Treatment for Adolescents with Depression Study (TADS). J Am Acad Child Adolesc Psychiatry. 2010 Feb;49(2):132-40. doi: 10.1097/00004583-201002000-00007.

    PMID: 20215935DERIVED

  • Kratochvil CJ, May DE, Silva SG, Madaan V, Puumala SE, Curry JF, Walkup J, Kepley H, Vitiello B, March JS. Treatment response in depressed adolescents with and without co-morbid attention-deficit/hyperactivity disorder in the Treatment for Adolescents with Depression Study. J Child Adolesc Psychopharmacol. 2009 Oct;19(5):519-27. doi: 10.1089/cap.2008.0143.

    PMID: 19877976DERIVED

  • Treatment for Adolescents With Depression Study (TADS) Team; March J, Silva S, Curry J, Wells K, Fairbank J, Burns B, Domino M, Vitiello B, Severe J, Riedal K, Goldman M, Feeny N, Findling R, Stull S, Baab S, Weller EB, Robbins M, Weller RA, Jessani N, Waslick B, Sweeney M, Dublin R, Walkup J, Ginsburg G, Kastelic E, Koo H, Kratochvil C, May D, LaGrone R, Vaughan B, Albano AM, Hirsch GS, Podniesinki E, Chu A, Reincecke M, Leventhal B, Rogers G, Jacobs R, Pathak S, Wells J, Lavanier SA, Danielyan A, Rohde P, Simons A, Grimm J, Frank S, Emslie G, Kennard B, Hughes C, Mayes TL, Rosenberg D, Benazon N, Butkus M, Bartoi M. The Treatment for Adolescents With Depression Study (TADS): outcomes over 1 year of naturalistic follow-up. Am J Psychiatry. 2009 Oct;166(10):1141-9. doi: 10.1176/appi.ajp.2009.08111620. Epub 2009 Sep 1.

    PMID: 19723787DERIVED

  • Domino ME, Foster EM, Vitiello B, Kratochvil CJ, Burns BJ, Silva SG, Reinecke MA, March JS. Relative cost-effectiveness of treatments for adolescent depression: 36-week results from the TADS randomized trial. J Am Acad Child Adolesc Psychiatry. 2009 Jul;48(7):711-720. doi: 10.1097/CHI.0b013e3181a2b319.

    PMID: 19465880DERIVED

  • Rohde P, Silva SG, Tonev ST, Kennard BD, Vitiello B, Kratochvil CJ, Reinecke MA, Curry JF, Simons AD, March JS. Achievement and maintenance of sustained response during the Treatment for Adolescents With Depression Study continuation and maintenance therapy. Arch Gen Psychiatry. 2008 Apr;65(4):447-55. doi: 10.1001/archpsyc.65.4.447.

    PMID: 18391133DERIVED

  • Vitiello B, Kratochvil CJ, Silva S, Curry J, Reinecke M, Pathak S, Waslick B, Hughes CW, Prentice ED, May DE, March JS. Research knowledge among the participants in the Treatment for Adolescents With Depression Study (TADS). J Am Acad Child Adolesc Psychiatry. 2007 Dec;46(12):1642-50. doi: 10.1097/chi.0b013e318153f8c7.

    PMID: 18030086DERIVED

  • May DE, Kratochvil CJ, Puumala SE, Silva SG, Rezac AJ, Hallin MJ, Reinecke MA, Vitiello B, Weller EB, Pathak S, Simons AD, March JS. A manual-based intervention to address clinical crises and retain patients in the Treatment of Adolescents With Depression Study (TADS). J Am Acad Child Adolesc Psychiatry. 2007 May;46(5):573-581. doi: 10.1097/chi.0b013e3180323342.

    PMID: 17450048DERIVED

Related Links

MeSH Terms

Conditions

Depressive Disorder, MajorDepression

Interventions

FluoxetinePsychotherapy

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental DisordersBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

PropylaminesAminesOrganic ChemicalsBehavioral Disciplines and Activities

Study Officials

  • John March

    Duke University

    STUDY DIRECTOR

  • Anne Marie Albano

    NYU Langone Health

    PRINCIPAL INVESTIGATOR

  • David Rosenberg, MD

    Wayne State Univ

    PRINCIPAL INVESTIGATOR

  • Charles Casat

    Carolinas Medical Center-Randlolph

    PRINCIPAL INVESTIGATOR

  • Graham Emslie

    University of Texas Soutwestern

    PRINCIPAL INVESTIGATOR

  • Christopher Kratochvil

    University of Nebraska

    PRINCIPAL INVESTIGATOR

  • Paul Rohde and Anne Simons

    University of Oregon

    PRINCIPAL INVESTIGATOR

  • John Walkup

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

  • Elizabeth Weller

    Children's Hospital of Philadelphia

    PRINCIPAL INVESTIGATOR

  • Bruce Waslick

    New York State Psychiatric Inst

    PRINCIPAL INVESTIGATOR

  • Mark Reinecke

    Northwestern University

    PRINCIPAL INVESTIGATOR

  • Elizabeth Cottingham, MD

    Children's Hospital Medical Center, Cincinnati

    PRINCIPAL INVESTIGATOR

  • Norah Feeny, PhD

    Case Western Reserve University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

September 14, 2000

First Posted

September 15, 2000

Study Start

September 1, 1998

Study Completion

March 1, 2004

Last Updated

April 17, 2014

Record last verified: 2005-11

Locations

US(12)