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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: Completed Phase 4 study, sponsored by National Institute of Mental Health (NIMH).
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, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (672% higher). According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT00021528 record still lists
NCT00021528 is an interventional study that assigns participants to a tested intervention. Its 4,000 participants enrollment target places it among the larger protocols in the corpus, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (672% higher).
The record links to 0 conditions, and to 5 interventions - of which Lithium is the first listed.
NCT00021528 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00021528's enrollment target sits among peer trials
4,000 20th of 2000 higher than 1,980 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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