Are Bright Lights and Regulated Sleep Effective Treatment for Depression?

Are Bright Lights and Regulated Sleep Effective Treatment for Depression.

Sponsors

Lead Sponsor: New York State Psychiatric Institute

Source New York State Psychiatric Institute
Brief 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.

Detailed Description

This study will investigate the utility of regimented sleep and lights in depressed subjects. Based on current timing of sleep, desired sleep time and responses to the Morningness-Eveningness Questionnaire, each subject who remains significantly depressed at their randomization (usually 2nd) visit, will be randomly assigned to one of two regimented sleep and light use protocols. On the night beginning their assigned regimented protocol, each subject will wear amber goggles for five hours and collect half hourly saliva samples for four hours. Each morning they will sit in front of a light box wearing goggles. During the first week following the start of the regimented protocol, they will complete self-report forms and have a telephone interview to document their depressive symptoms. They will have weekly in person interviews for six weeks and evaluations by an independent evaluator in person or by telephone at randomization, 2 and 6 weeks. Prior to their Week 2 Visit, they will wear the goggles for the four hours prior to their assigned bedtime and for the three hours prior to their assigned bedtime, they will collect half hourly saliva samples. At their Week 6 interview, they and their doctor will determine whether they have improved sufficiently or not. Their doctor will discuss with them whether it makes sense for them to continue the same regimented sleep/light schedule, make a change to it or switch to or add additional treatment, such as antidepressant medication. They will then be followed with study ratings monthly for six months, during which treatment is unrestricted; that is, the doctor and patient can determine what the treatment during this time will be. Following the six months follow-up, a referral will be made if appropriate.

All saliva samples will be analyzed for melatonin concentration.

Overall Status Recruiting
Start Date November 2016
Completion Date November 2021
Primary Completion Date November 2020
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
17-Item Hamilton Rating Scale for Depression Score (Independent Evaluator) Week 6
Secondary Outcome
Measure Time Frame
Participant Sleep Efficiency Week 6
Enrollment 60
Condition
Intervention

Intervention Type: Behavioral

Intervention Name: Morning Light Therapy

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

Other Name: Light Therapy

Intervention Type: Behavioral

Intervention Name: Assigned Sleep Times

Description: 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.

Other Name: Sleep Phase Advance

Intervention Type: Device

Intervention Name: Goggles

Description: Subjects will wear goggles during saliva collection and Bright Light Therapy

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

Gender: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Jonathan W Stewart, MD Principal Investigator New York State Psychiatric Institute
Overall Contact

Last Name: Peter C Arden, BA

Phone: 646-774-8004

Email: [email protected]

Location
Facility: Status: Contact: Contact Backup: Investigator: Depression Evaluation Service - New York State Psychiatric Institute Jonathan W. Stewart, M.D. 646-774-8070 [email protected] Jonathan W. Stewart, M.D. Principal Investigator David Hellerstein, M.D. Sub-Investigator
Location Countries

United States

Verification Date

October 2019

Responsible Party

Type: Principal Investigator

Investigator Affiliation: New York State Psychiatric Institute

Investigator Full Name: David J. Hellerstein

Investigator Title: Dr. Jonathan W. Stewart M.D.

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Rapid Sleep Shift

Type: Experimental

Description: Assigned Sleep Times designed to shift sleep times over several days from Baseline to desired through morning light therapy while wearing goggles.

Label: Gradual Sleep Shift

Type: Active Comparator

Description: Assigned Sleep Times designed gradually shift sleep from current to desired sleep times while using morning light therapy while wearing goggles.

Patient Data Yes
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Double (Participant, Outcomes Assessor)

Source: ClinicalTrials.gov