The TADS trial closed enrollment on July 31st, 2003.
- 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.
are 2 to 3 screening visits to determine whether teens are eligible
for TADS. Parents and teens also are asked to complete several questionnaires
- 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:
For the first 12 weeks only, some teens will receive
a placebo (sugar pill) control treatment.
- Fluoxetine (ProzacŪ) - medication alone
- Placebo (sugar pill) - medication alone
- Cognitive Behavior Therapy (CBT) - talking with a therapist
- Combination of both medication and CBT
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.
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.
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.
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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