CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 44 enrolled
Drug / intervention
Morning Light Therapy +2 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03010488
NCT03010488N/ACompleted

Are Bright Lights and Regulated Sleep Effective Treatment for Depression.

New York State Psychiatric Institute·interventional·Posted Jan 5, 2017·Updated Mar 23, 2021

In Brief

A clinical study evaluating Morning Light Therapy, Assigned Sleep Times, and 1 other intervention for Sleep Phase Rhythm Disturbance and Sleep Deprivation. Completed, enrolled 44 participants across 1 site.

Detailed 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 saliva melatonin levels, sleep logs and activity monitor data will measure the timing of the biological clock and whether it has been shifted by the treatment. Measures of functioning will determine whether functioning improves coincident with, independent of, or subsequent to mood improvement.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedJan 5, 2017
Enrollment StartNov 1, 2016
Primary CompletionJun 1, 2019
Study CompletionAug 1, 2019
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 9.5 years ago

Interventions

Morning Light Therapybehavioral

10,000 Lux light for 30 minutes through a light box each morning at patient's desired wake up time.

Assigned Sleep Timesbehavioral

Sleep times will be assigned to subjects that will allow them to drive their regular sleep times closer to those they determine to be optimal at study initiation.

Gogglesdevice

Subjects will wear goggles during saliva collection and Bright Light Therapy