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NCT00006286 · ClinicalTrials.gov registry record · Phase 3
Treatment for Adolescents With Depression Study (TADS)
A Phase 3 study, sponsored by National Institute of Mental Health (NIMH).
- Completed
- Registry status
- Phase 3
- Development phase
- 432
- Enrollment target
NCT00006286 is a Phase 3 study that has completed, run by National Institute of Mental Health (NIMH). The registered enrollment target is 432 participants.
The verdict
NCT00006286, a Phase 3 study, has completed, sponsored by National Institute of Mental Health (NIMH).
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 432 participants
- Enrollment target
Study 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.
Interventions
- BEHAVIORAL Psychotherapy
- DRUG Fluoxetine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 432 participants |
| Start Date | 1998-09 |
| Est. Completion | 2004-03 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00006286
The ClinicalTrials.gov registry entry for NCT00006286 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 432 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Mental Health (NIMH), which has 343 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Psychotherapy is the first listed.
NCT00006286 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00006286 about?
NCT00006286 is a clinical study titled "Treatment for Adolescents With Depression Study (TADS)". 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 fema...
What is the current status of trial NCT00006286?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 432 participants. The study started on 1998-09. Estimated completion is 2004-03.
What interventions are being tested in trial NCT00006286?
The interventions under investigation include: Psychotherapy (BEHAVIORAL), Fluoxetine (DRUG).
Who is sponsoring clinical trial NCT00006286?
This trial is sponsored by National Institute of Mental Health (NIMH), which has 343 total clinical trials registered on ClinicalTrials.gov.
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