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NCT00021528 · ClinicalTrials.gov registry record · Phase 4
Sequenced Treatment Alternatives to Relieve Depression (STAR*D)
A Phase 4 study, sponsored by National Institute of Mental Health (NIMH).
- Completed
- Registry status
- Phase 4
- Development phase
- 4,000
- Enrollment target
NCT00021528 is a Phase 4 study that has completed, run by National Institute of Mental Health (NIMH). The registered enrollment target is 4,000 participants.
The verdict
NCT00021528, a Phase 4 study, has completed, sponsored by National Institute of Mental Health (NIMH).
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 4,000 participants
- Enrollment target
Study Summary
STAR\*D focuses on non-psychotic major depressive disorder in adults who are seen in outpatient settings. The primary purpose of this research study is to determine which treatments work best if the first treatment with medication does not produce an acceptable response. Participants will first receive citalopram, an SSRI medication; if symptoms remain after 8-12 weeks of treatment, up to four other levels of treatment will be offered, including cognitive therapy and other medications. There are no placebo treatments. Some patients may require a combination of two or more treatments to obtain full benefit. Participation could last from 15 to 27 months and involve up to 30 clinic visits. Participants will be interviewed by telephone throughout the study about their symptoms, daily functioning, treatment side effects, use of the health care system, and satisfaction with treatment. There will be a one-year follow up for participants once their depression has been successfully treated
Interventions
- DRUG Lithium
- DRUG mirtazapine
- DRUG citalopram
- DRUG buspirone
- DRUG BuproprionSR
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4,000 participants |
| Start Date | 2001-07 |
| Est. Completion | 2006-09 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00021528
The ClinicalTrials.gov registry entry for NCT00021528 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 4,000 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 5 interventions - of which Lithium is the first listed.
NCT00021528 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00021528 about?
NCT00021528 is a clinical study titled "Sequenced Treatment Alternatives to Relieve Depression (STAR*D)". STAR\*D focuses on non-psychotic major depressive disorder in adults who are seen in outpatient settings. The primary purpose of this research study is to determine which treatments work best if the first treatment with medication does not produce an acceptable response. Participants will first rece...
What is the current status of trial NCT00021528?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 4,000 participants. The study started on 2001-07. Estimated completion is 2006-09.
What interventions are being tested in trial NCT00021528?
The interventions under investigation include: Lithium (DRUG), mirtazapine (DRUG), citalopram (DRUG), buspirone (DRUG), BuproprionSR (DRUG).
Who is sponsoring clinical trial NCT00021528?
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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