Are Bright Lights and Regulated Sleep Effective Treatment for Depression?

NCT03010488 | Completed Results

• 1 other identifier: 7361
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Phase Rhythm Disturbance; Sleep Deprivation

Keywords

Chronotherapy; Light Therapy

Outcome Measures

Primary Outcomes (1)

• 17-Item Hamilton Rating Scale for Depression Score (Independent Evaluator)

  Independent Evaluator's Week 6 17-item Hamilton Rating Scale for Depression Summary Score. The 17-item Hamilton is the standard measure of depression severity for clinical trials of antidepressants and was chosen as the primary outcome measure over other depression rating scales to ensure compatibility of study results with our meta-analyses and ongoing studies of expectancy. Although the Hamilton list 24 items, the scoring is based on both the first 17 items and the full 24 items. sum of the scores of the first 17 items (range from 0 to 54): 0-7 = NORMAL 8-13 = Mild Depression 14-18 = Moderate Depression 19-22 = Severe Depression \>=23 = Very Severe Depression

  Week 6

Secondary Outcomes (1)

• Participant Sleep Efficiency

  Week 6

Study Arms (2)

Rapid Sleep Shift

EXPERIMENTAL

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

Behavioral: Morning Light Therapy; Behavioral: Assigned Sleep Times; Device: Goggles

Gradual Sleep Shift

ACTIVE COMPARATOR

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

Behavioral: Morning Light Therapy; Behavioral: Assigned Sleep Times; Device: Goggles

Interventions

Morning Light Therapy BEHAVIORAL

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

Also known as: Light Therapy

Gradual Sleep Shift; Rapid Sleep Shift

Assigned Sleep Times BEHAVIORAL

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.

Also known as: Sleep Phase Advance

Gradual Sleep Shift; Rapid Sleep Shift

Goggles DEVICE

Subjects will wear goggles during saliva collection and Bright Light Therapy

Gradual Sleep Shift; Rapid Sleep Shift

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Currently Depressed
• In reasonably good physical health

You may not qualify if:

• 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

Sponsors & Collaborators

• New York State Psychiatric Institute: lead

Study Sites (1)

Depression Evaluation Service - New York State Psychiatric Institute

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Sleep Deprivation

Interventions

Phototherapy; Sleep Phase Chronotherapy; Eye Protective Devices

Condition Hierarchy (Ancestors)

Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

Therapeutics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Personal Protective Equipment; Protective Devices; Equipment and Supplies; Manufactured Materials; Technology, Industry, and Agriculture

Results Point of Contact

• Title: David Hellerstein
• Organization: New York State Psychiatric Institute

david.hellerstein@nyspi.columbia.edu

646-774-8069

Study Officials

• Jonathan W Stewart, MD

  New York State Psychiatric Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Clinical Psychiatry

Study Record Dates

• First Submitted: January 3, 2017
• First Posted: January 5, 2017
• Study Start: November 1, 2016
• Primary Completion: June 1, 2019
• Study Completion: August 1, 2019
• Last Updated: March 23, 2021
• Results First Posted: March 23, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR, ANALYTIC CODE
• Time Frame: Information will be sent as soon as is practical and will be available as long as the PI is available.
• Access Criteria: Legitimate research agenda, including but not limited to request to double-check presented or published results and novel analyses.

Locations

US (1)