N/A
N=44
Are Bright Lights and Regulated Sleep Effective Treatment for Depression?
Sleep Phase Rhythm Disturbance · Sleep Deprivation
Bottom Line
View on ClinicalTrials.gov: NCT03010488 ↗Enrolled (actual)
44
Serious AEs
0.0%
Results posted
Mar 2021
Primary outcome: Primary: 17-Item Hamilton Rating Scale for Depression Score (Independent Evaluator) — 8.66; 10.46 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Morning Light Therapy (Behavioral); Assigned Sleep Times (Behavioral); Goggles (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- New York State Psychiatric Institute
- Primary completion
- Jun 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 17-Item Hamilton Rating Scale for Depression Score (Independent Evaluator) |
8.66; 10.46 | — |
| SECONDARY Participant Sleep Efficiency |
76.43; 68.23 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Currently Depressed
- In reasonably good physical health
Exclusion Criteria
- Bipolar Disorder (I, II, or unspecified)
- History of psychosis
- Unstable medical condition
- Current (past 6 months) drug or alcohol use disorder
- Need for hospitalization
- Treating clinician determines not to include patient in this protocol
- Currently taking medications approved for the treatment of depression
- Un- or poorly controlled hypertension
- Pregnancy
Data sourced from ClinicalTrials.gov (NCT03010488). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.