Treatment for Adolescents With Depression Study (TADS)
Condition: Major Depressive Disorder; Depression
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 3

Summary: 
      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.
    

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.
    

Intervention name(s): Fluoxetine; Psychotherapy
Intervention type(s): Drug; Behavioral
Intervention MeSH terms: Fluoxetine
Allocation: Randomized
Masking: Double
Primary purpose: Treatment
Keywords: Depression; Major Depressive Disorder; Fluoxetine; Prozac; SSRI; Psychotherapy; CBT; Teenagers; Adolescents; Teens