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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 is a Phase 1 study that has completed, run by University of California, Irvine. The registered enrollment target is 49 participants.

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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.

Interventions

  • OTHER chronobiological augmentation
  • DRUG sertraline, lithium
  • RADIATION one night of sleep deprivation and two FDG PET scans

Trial Details

FieldValue
Enrollment Target 49 participants
Start Date 2001-05-30
Est. Completion 2011-12-09
Phase Phase 1

Sponsor

University of California, Irvine

368 total trials

What the Registry Record Tells You About NCT00581009

The ClinicalTrials.gov registry entry for NCT00581009 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 49 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, Irvine, which has 368 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 3 interventions - of which chronobiological augmentation is the first listed.

NCT00581009 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.