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National Institute of Mental Health A clinical trial sponsored by the National Institute of Mental Health

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The TADS trial closed enrollment on July 31st, 2003.

Study Overview

  • The goal of TADS is to determine the best way to treat depression in teenagers. TADS is sponsored by the National Institute of Mental Health (NIMH).
  • Boys and girls, 12 to 17 years of age, who suffer from Major Depressive Disorder (MDD) can participate.
  • TADS will compare the short and long term improvements in symptoms of MDD from three treatments and one control treatment in 432 teens from 10 sites across the United States.
  • There are 2 to 3 screening visits to determine whether teens are eligible for TADS. Parents and teens also are asked to complete several questionnaires and interviews.
  • If the teen is eligible and both parent and teen consent to participate, the teen will be randomly assigned to one of four treatments that have been proven effective with many adolscents:
    • Fluoxetine (ProzacŪ) - medication alone

    • Placebo (sugar pill) - medication alone

    • Cognitive Behavior Therapy (CBT) - talking with a therapist

    • Combination of both medication and CBT
    For the first 12 weeks only, some teens will receive a placebo (sugar pill) control treatment.
  • Treatment is conducted in Stages up to a total of 9 months, depending on how well the teen is doing. The first Stage lasts up to 12 weeks and at the end of it, teens assigned to Prozac and teens assigned to Placebo will be told what they have been getting. Teens who had been getting Placebo may, if they want to, choose to receive any of the other three treatments for the next 12 weeks. All others who are doing well will continue to receive their same treatment for another 6 months.
  • Visits to the Clinic will be necessary for treatment and assessment. They will occur more often in the beginning of the trial and less often later on. The total number of visits depends on the treatment assigned and how well the teen responds to treatment. Some visits will take only 30 minutes; others will require several hours.
  • After the treatment period ends, there is a 1-year assessment period that will include four assessment visits, about 3 months apart. Thus teens may be asked to participate for up to 21 months in all.
  • TADS requires that at least one parent complete various questionnaires and/or interviews. Parents also will be asked to participate in some treatment sessions. If the teen does not live with one or both parents, we ask that an adult with whom the teen lives most of the time take part in the study.
  • Study participation can offer several benefits. For example, study treatment may help ease the teen's symptoms of depression. We also hope that the overall study results will improve the future care of depressed teens.

 

 

 

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