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Completed Phase 3 Interventional

Treatment for Adolescents With Depression Study (TADS)

ClinicalTrials.gov ID: NCT00006286

Public ClinicalTrials.gov record NCT00006286. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 30, 2026, 3:31 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 identification

NCT ID
NCT00006286
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Enrollment
432 participants

Conditions and interventions

Interventions

Drug · Behavioral

Eligibility (public fields only)

Age range
12 Years to 17 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Sep 1998 (Type not available)
Primary completion
Not listed
Completion
Mar 2004 (Type not available)
Last update posted
Apr 17, 2014

1998 – 2004

United States locations

U.S. sites
12
U.S. states
10
U.S. cities
11
Facility City State ZIP Site status
Northwestern University Chicago Illinois 60611 —
Johns Hopkins Hospital Baltimore Maryland 21287 —
Wayne State University Detroit Michigan 48207 —
University of Nebraska Medical Center Omaha Nebraska 68198-5581 —
New York University Medical Center New York New York 10016 —
New York State Psychiatric Institute New York New York 10032 —
Behavioral Health Center Charlotte North Carolina 28203 —
Children's Hospital Medical Center Cincinnati Ohio 45229 —
Case Western Reserve University Cleveland Ohio 44106 —
University of Oregon Eugene Oregon 97403 —
Children's Hospital of Philadelphia Philadelphia Pennsylvania 19104 —
University of Texas Southwestern Medical Center at Dallas Dallas Texas 75235 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00006286, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Apr 17, 2014 · Synced Sep 30, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00006286 live on ClinicalTrials.gov.

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