Treatment for Adolescents With Depression Study (TADS)

Completed · Phase 3

Conditions studied: Major Depressive Disorder, Depression

In brief

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.

Key facts

Study ID: NCT00006286
Run by: National Institute of Mental Health (NIMH)
People needed: 432
Starts: 1998-09-01
Expected to finish: 2004-03-01
Last updated by the study team: 2014-04-17

Who can join

Age: 12 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

Northwestern University — Chicago, Illinois, United States
Johns Hopkins Hospital — Baltimore, Maryland, United States
Wayne State University — Detroit, Michigan, United States
University of Nebraska Medical Center — Omaha, Nebraska, United States
New York University Medical Center — New York, New York, United States
New York State Psychiatric Institute — New York, New York, United States
Behavioral Health Center — Charlotte, North Carolina, United States
Children's Hospital Medical Center — Cincinnati, Ohio, United States
Case Western Reserve University — Cleveland, Ohio, United States
University of Oregon — Eugene, Oregon, United States
Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
University of Texas Southwestern Medical Center at Dallas — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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