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NCT03010488 · ClinicalTrials.gov registry record · NA
Are Bright Lights and Regulated Sleep Effective Treatment for Depression?
A NA study of Sleep Deprivation and Sleep Phase Rhythm Disturbance, sponsored by New York State Psychiatric Institute.
- Completed
- Registry status
- NA
- Development phase
- 44
- Enrollment target
- 1
- Study location
NCT03010488 is a NA study of Sleep Deprivation and Sleep Phase Rhythm Disturbance that has completed, run by New York State Psychiatric Institute. The registered enrollment target is 44 participants, below the 90-participant average among 34 other Sleep Deprivation trials with a reported enrollment target (51% lower). The trial reports 1 study location across 1 state.
The verdict
NCT03010488, a NA study of Sleep Deprivation and Sleep Phase Rhythm Disturbance, has completed, sponsored by New York State Psychiatric Institute.
- COMPLETED
- Registry status
- NA
- Development phase
- 44 participants
- Enrollment target
- 1
- Study location
Study Summary
Previous data suggest some depressed patients act as if their internal biological clock is out of sync with the outside world and re-aligning their clock with the timing of sunlight lessens their depressed mood and accompanying depressive symptoms. This "chronotherapy" may produce remission during the first week of treatment while causing minimal problems. This study aims to demonstrate the efficacy of chronotherapy by comparing two protocols for inducing sleep phase advance. Which chronotherapy condition a participant will receive will be determined randomly (i.e., by chance, essentially a computerized flip of a coin). Prior to determination of which protocol a patient will follow, each patient will declare their desired sleep time (for example, 11 p.m. to 7 a.m.). All patients will be assigned specific times to sleep and sit in front of bight lights wearing clear or amber goggles. Assigned sleep times will differ between groups using different strategies to shift the timing of their sleep from their ideal sleep time as determined by their Morningness-Eveningness Questionnaire (MEQ) score to their desired sleep time. All participants will be rated daily by telephone for the first week following randomization, and then weekly for an additional five weeks. Whenever possible, weekly visits will be in person, although telephone visits will be allowed. All participants will be rated at baseline, 1 week and 6 weeks by an Independent Evaluator blind to treatment assignment (as well as the nature of the treatment and if it has occurred or not). After the six week post-randomization evaluation, all participants will be offered six months of continued treatment and be rated monthly. Treatment during this six month period may consist of Chronotherapy or conventional antidepressants as the patient and doctor determine. Standard ratings of depression, over-all illness and functioning will be obtained. Change in the symptom measures will determine treatment efficacy. Analysis of
Conditions Studied
Interventions
- DEVICE Goggles
- BEHAVIORAL Morning Light Therapy
- BEHAVIORAL Assigned Sleep Times
Study Locations (1)
New York
- Depression Evaluation Service - New York State Psychiatric Institute - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2016-11 |
| Est. Completion | 2019-08 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03010488
The ClinicalTrials.gov registry entry for NCT03010488 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 44 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 90-participant average among 34 other Sleep Deprivation trials with a reported enrollment target (51% lower). The listed sponsor is New York State Psychiatric Institute, which has 364 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Sleep Deprivation appearing as the primary indexed condition, and to 3 interventions - of which Goggles is the first listed.
NCT03010488 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.
Frequently Asked Questions
What is clinical trial NCT03010488 about?
NCT03010488 is a clinical study titled "Are Bright Lights and Regulated Sleep Effective Treatment for Depression?". Previous data suggest some depressed patients act as if their internal biological clock is out of sync with the outside world and re-aligning their clock with the timing of sunlight lessens their depressed mood and accompanying depressive symptoms. This "chronotherapy" may produce remission during t...
What is the current status of trial NCT03010488?
This trial is currently completed. It is a NA study. The enrollment target is 44 participants. The study started on 2016-11. Estimated completion is 2019-08.
What conditions does trial NCT03010488 study?
This clinical trial studies the following conditions: Sleep Deprivation, Sleep Phase Rhythm Disturbance.
What interventions are being tested in trial NCT03010488?
The interventions under investigation include: Goggles (DEVICE), Morning Light Therapy (BEHAVIORAL), Assigned Sleep Times (BEHAVIORAL).
Who is sponsoring clinical trial NCT03010488?
This trial is sponsored by New York State Psychiatric Institute, which has 364 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03010488 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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