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Sponsored by: |
National Institute of Mental Health (NIMH) |
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Information provided by: | National Institute of Mental Health (NIMH) |
ClinicalTrials.gov Identifier: | NCT00006286 |
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.
Condition | Intervention | Phase |
---|---|---|
Major Depressive Disorder Depression |
Drug: Fluoxetine Behavioral: Psychotherapy |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control |
Official Title: | Treatment for Adolescents With Depression Study (TADS) |
Estimated Enrollment: | 432 |
Study Start Date: | September 1998 |
Estimated Study Completion Date: | March 2004 |
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.
Ages Eligible for Study: | 12 Years to 17 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Illinois | |
Northwestern University | |
Chicago, Illinois, United States, 60611 | |
United States, Maryland | |
Johns Hopkins Hospital | |
Baltimore, Maryland, United States, 21287 | |
United States, Michigan | |
Wayne State University | |
Detroit, Michigan, United States, 48207 | |
United States, Nebraska | |
University of Nebraska Medical Center | |
Omaha, Nebraska, United States, 68198-5581 | |
United States, New York | |
New York University Medical Center | |
New York, New York, United States, 10016 | |
New York State Psychiatric Institute | |
New York, New York, United States, 10032 | |
United States, North Carolina | |
Behavioral Health Center | |
Charlotte, North Carolina, United States, 28203 | |
United States, Ohio | |
Case Western Reserve University | |
Cleveland, Ohio, United States, 44106 | |
Children's Hospital Medical Center | |
Cincinnati, Ohio, United States, 45229 | |
United States, Oregon | |
University of Oregon | |
Eugene, Oregon, United States, 97403 | |
United States, Pennsylvania | |
Children's Hospital of Philadelphia | |
Philadelphia, Pennsylvania, United States, 19104 | |
United States, Texas | |
University of Texas Southwestern Medical Center at Dallas | |
Dallas, Texas, United States, 75235 |
Study Director: | John March | Duke University |
Principal Investigator: | Anne Marie Albano | New York University Medical Center |
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 |
Study ID Numbers: | N01 MH80008, DSIR CT |
Study First Received: | September 14, 2000 |
Last Updated: | January 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00006286 |
Health Authority: | United States: Federal Government |
Depression Major Depressive Disorder Fluoxetine Prozac SSRI |
Psychotherapy CBT Teenagers Adolescents Teens |
Fluoxetine Depression Mental Disorders Mood Disorders |
Depressive Disorder, Major Depressive Disorder Serotonin Behavioral Symptoms |
Neurotransmitter Agents Neurotransmitter Uptake Inhibitors Serotonin Agents Molecular Mechanisms of Pharmacological Action Therapeutic Uses Physiological Effects of Drugs |
Psychotropic Drugs Antidepressive Agents, Second-Generation Central Nervous System Agents Serotonin Uptake Inhibitors Antidepressive Agents Pharmacologic Actions |