Treatment for Adolescents With Depression Study (TADS)

April 16, 2014 updated by: National Institute of Mental Health (NIMH)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

432

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins Hospital
    • Michigan
      • Detroit, Michigan, United States, 48207
        • Wayne State University
    • Nebraska
      • Omaha, Nebraska, United States, 68198-5581
        • University of Nebraska Medical Center
    • New York
      • New York, New York, United States, 10016
        • New York University Medical Center
      • New York, New York, United States, 10032
        • New York State Psychiatric Institute
    • North Carolina
      • Charlotte, North Carolina, United States, 28203
        • Behavioral Health Center
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Children's Hospital Medical Center
      • Cleveland, Ohio, United States, 44106
        • Case Western Reserve University
    • Oregon
      • Eugene, Oregon, United States, 97403
        • University of Oregon
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Children's Hospital of Philadelphia
    • Texas
      • Dallas, Texas, United States, 75235
        • University of Texas Southwestern Medical Center at Dallas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 17 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Masking: DOUBLE

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Mental Health (NIMH)

Investigators

  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 1998

Study Completion

March 1, 2004

Study Registration Dates

First Submitted

September 14, 2000

First Submitted That Met QC Criteria

September 14, 2000

First Posted (ESTIMATE)

September 15, 2000

Study Record Updates

Last Update Posted (ESTIMATE)

April 17, 2014

Last Update Submitted That Met QC Criteria

April 16, 2014

Last Verified

November 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N01 MH80008
  • DSIR CT

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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