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Treatment for Adolescents With Depression Study (TADS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00006286
Recruitment Status : Completed
First Posted : September 15, 2000
Last Update Posted : April 17, 2014
Information provided by:
National Institute of Mental Health (NIMH)

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.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Depression Drug: Fluoxetine Behavioral: Psychotherapy Phase 3

Detailed Description:

TADS is a randomized controlled clinical trial that will compare the effectiveness of established treatments---cognitive-behavioral psychotherapy, medication management, and their combination---for adolescents suffering from major depressive disorder (MDD).

The experimental design consists of three treatment stages and a follow-up phase. Stage I (12 weeks) is a four-group randomized comparison of four treatments: antidepressant medication alone (Fluoxetine); psychotherapy alone (CBT); a combination of the medication and psychotherapy (Comb); and a placebo control medication condition (Pbo). Stage II (six weeks) is a treatment consolidation phase in which we ask whether longer treatment in responders and higher intensity treatment in partial responders to their Stage I treatment would be helpful. Non-responders at the end of Stage I will be referred to open community treatment, or for ethical and practical reasons in the case of non-responders to Placebo, to open treatment of their choice with one of the three active study treatments administered by the study team. Responders at the end of Stage I advance to 6 weeks of maintenance treatment in their assigned arm. Partial responders to CBT receive an additional 6 weeks of CBT in their assigned arm; partial responders to Fluoxetine may receive a higher dose for six weeks. Partial responders to the Comb treatment will receive an additional 6 weeks of CBT and may receive a higher dose of medication for six weeks. Stage III (18 weeks) is a treatment maintenance phase for those teenagers who have continued to respond well. Treatment will be continued and progress will be monitored. Stage IV (one year) is an assessment-only follow-up phase to help us understand the long-term benefits of the treatments.

The recruitment strategy is designed to enter into treatment a volunteer clinical sample of 432 teenagers, both males and females, ages 12 to 17, at ten sites. A multiple gating procedure will be used in which patients will be screened, assessed for study eligibility, and if eligible, consented before randomization to one of the four treatment groups. Patients will be selected without regard to race, gender, or ethnicity and it is expected that the sample will match patients seen in general clinical practice. Patients will be recruited from multiple sources including: mental health identified children, i.e., children already coming to a clinic; primary care identified children (pediatric and family physicians); teacher or school identified children (i.e., school refers through the parents or primary caretaker); and families who self-refer.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 432 participants
Allocation: Randomized
Masking: Double
Primary Purpose: Treatment
Official Title: Treatment for Adolescents With Depression Study (TADS)
Study Start Date : September 1998
Study Completion Date : March 2004

Resource links provided by the National Library of Medicine

Drug Information available for: Fluoxetine

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   12 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00006286

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United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
United States, Maryland
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
United States, Michigan
Wayne State University
Detroit, Michigan, United States, 48207
United States, Nebraska
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198-5581
United States, New York
New York University Medical Center
New York, New York, United States, 10016
New York State Psychiatric Institute
New York, New York, United States, 10032
United States, North Carolina
Behavioral Health Center
Charlotte, North Carolina, United States, 28203
United States, Ohio
Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Case Western Reserve University
Cleveland, Ohio, United States, 44106
United States, Oregon
University of Oregon
Eugene, Oregon, United States, 97403
United States, Pennsylvania
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, United States, 75235
Sponsors and Collaborators
National Institute of Mental Health (NIMH)
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Study Director: John March Duke University
Principal Investigator: 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
Additional Information:
Publications of Results:

Other Publications:
Publications automatically indexed to this study by Identifier (NCT Number):
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.

Layout table for additonal information Identifier: NCT00006286    
Other Study ID Numbers: N01 MH80008
First Posted: September 15, 2000    Key Record Dates
Last Update Posted: April 17, 2014
Last Verified: November 2005
Keywords provided by National Institute of Mental Health (NIMH):
Major Depressive Disorder
Additional relevant MeSH terms:
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Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors