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NCT00581009 · ClinicalTrials.gov registry record · Phase 1
The Role of Dopamine Metabolism in the Antidepressant Effects of Sleep Deprivation and Sertraline in Depressed Patients
A Phase 1 study, sponsored by University of California, Irvine.
- Completed
- Registry status
- Phase 1
- Development phase
- 49
- Enrollment target
NCT00581009: Completed Phase 1 study, sponsored by University of California, Irvine.
NCT00581009 is a Phase 1 study that has completed, run by University of California, Irvine. The registered enrollment target is 49 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (18% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00581009, a Phase 1 study, has completed, sponsored by University of California, Irvine.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 49 participants
- Enrollment target
Study Summary
This study evaluates the efficacy of sleep deprivation treatment in accelerating antidepressant responses when administered during the first week of medications and augmenting a sustained response with chronobiological interventions. Sleep deprivation and chronobiological augmentation may offer a rapid and sustained antidepressant response in mood disorder patients treated with medication, sleep deprivation, bright light therapy and sleep phase advance compared with medication only. The chronobiological treatment is rapid, non-invasive and has few side effects and could be of significant clinical benefit.
Primary Outcome
Difference in HRSD between the chronobiological augmentation therapy and medication only groups across the first 7 days, and up to 7 weeks of treatment. The 21-item HRSD has a range of 0 to 66, with a higher score indicating more severe depression.
Interventions
- OTHER chronobiological augmentation
- DRUG sertraline, lithium
- RADIATION one night of sleep deprivation and two FDG PET scans
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 49 participants |
| Start Date | 2001-05-30 |
| Est. Completion | 2011-12-09 |
| Phase | Phase 1 |
What the finished NCT00581009 record still lists
NCT00581009 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 49 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (18% lower).
The record links to 0 conditions, and to 3 interventions - of which chronobiological augmentation is the first listed.
NCT00581009 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00581009 about?
NCT00581009 is a clinical study titled "The Role of Dopamine Metabolism in the Antidepressant Effects of Sleep Deprivation and Sertraline in Depressed Patients". This study evaluates the efficacy of sleep deprivation treatment in accelerating antidepressant responses when administered during the first week of medications and augmenting a sustained response with chronobiological interventions. Sleep deprivation and chronobiological augmentation may offer a ra...
What is the current status of trial NCT00581009?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 49 participants. The study started on 2001-05-30. Estimated completion is 2011-12-09.
What interventions are being tested in trial NCT00581009?
The interventions under investigation include: chronobiological augmentation (OTHER), sertraline, lithium (DRUG), one night of sleep deprivation and two FDG PET scans (RADIATION).
Who is sponsoring clinical trial NCT00581009?
This trial is sponsored by University of California, Irvine, which has 368 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00581009's enrollment target sits among peer trials
49 1017th of 2000 higher than 976 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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