Treatment for Adolescents With Depression Study (TADS)

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.

Conditions

• Major Depressive Disorder
• Depression

Interventions

DRUG

Fluoxetine

BEHAVIORAL

Psychotherapy

Sponsors & Collaborators

• National Institute of Mental Health (NIMH)

  lead NIH

Principal Investigators

• John March · Duke University

• Anne Marie Albano · NYU Langone Health

• David Rosenberg, MD · Wayne State Univ

• Charles Casat · Carolinas Medical Center-Randlolph

• Graham Emslie · University of Texas Soutwestern

• Christopher Kratochvil · University of Nebraska

• Paul Rohde and Anne Simons · University of Oregon

• John Walkup · Johns Hopkins University

• Elizabeth Weller · Children's Hospital of Philadelphia

• Bruce Waslick · New York State Psychiatric Inst

• Mark Reinecke · Northwestern University

• Elizabeth Cottingham, MD · Children's Hospital Medical Center, Cincinnati

• Norah Feeny, PhD · Case Western Reserve University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Eligibility

Min Age

12 Years

Max Age

17 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

1998-09-30

Completion

2004-03-31

Countries

• United States

Study Locations