Treatment for Adolescents With Depression Study (TADS)
Information source: National Institute of Mental Health (NIMH)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Major Depressive Disorder; Depression
Intervention: Fluoxetine (Drug); Psychotherapy (Behavioral)
Phase: Phase 3
Status: Completed
Sponsored by: National Institute of Mental Health (NIMH) Official(s) and/or principal investigator(s):
John March, Study Director, Affiliation: Duke University
Anne Marie Albano, Principal Investigator, Affiliation: New York University Medical Center
David Rosenberg, MD, Principal Investigator, Affiliation: Wayne State Univ
Charles Casat, Principal Investigator, Affiliation: Carolinas Medical Center-Randlolph
Graham Emslie, Principal Investigator, Affiliation: University of Texas Soutwestern
Christopher Kratochvil, Principal Investigator, Affiliation: University of Nebraska
Paul Rohde and Anne Simons, Principal Investigator, Affiliation: University of Oregon
John Walkup, Principal Investigator, Affiliation: Johns Hopkins University
Elizabeth Weller, Principal Investigator, Affiliation: Children's Hospital of Philadelphia
Bruce Waslick, Principal Investigator, Affiliation: New York State Psychiatric Inst
Mark Reinecke, Principal Investigator, Affiliation: Northwestern University
Elizabeth Cottingham, MD, Principal Investigator, Affiliation: Children's Hospital Medical Center, Cincinnati
Norah Feeny, PhD, Principal Investigator, Affiliation: Case Western Reserve University
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.
Clinical Details
Official title: Treatment for Adolescents With Depression Study (TADS)
Study design: Treatment, Randomized, Double-Blind, Placebo Control
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.
Eligibility
Minimum age: 12 Years.
Maximum age: 17 Years.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Northwestern University, Chicago, Illinois 60611, United States
Johns Hopkins Hospital, Baltimore, Maryland 21287, United States
Wayne State University, Detroit, Michigan 48207, United States
University of Nebraska Medical Center, Omaha, Nebraska 68198-5581, United States
New York University Medical Center, New York, New York 10016, United States
New York State Psychiatric Institute, New York, New York 10032, United States
Behavioral Health Center, Charlotte, North Carolina 28203, United States
Case Western Reserve University, Cleveland, Ohio 44106, United States
Children's Hospital Medical Center, Cincinnati, Ohio 45229, United States
University of Oregon, Eugene, Oregon 97403, United States
Children's Hospital of Philadelphia, Philadelphia, Pennsylvania 19104, United States
University of Texas Southwestern Medical Center at Dallas, Dallas, Texas 75235, United States
Additional Information
Coordinating Center Web Site NIMH Press Release
Related publications: Glass RM. Treatment of adolescents with major depression: contributions of a major trial. JAMA. 2004 Aug 18;292(7):861-3. No abstract available. 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.
Starting date: September 1998
Ending date: March 2004
Last updated: January 18, 2008
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