RECRUITING

Feasibility of Home-Based Intermittent 60Hz Light Therapy for Major Depressive Disorder (MDD)

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Conditions

DepressionMDDMajor Depressive DisorderMajor Depressive EpisodeBrain stimulationLight therapyWearableNeuromodulationTelehealth

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This pilot study evaluates the feasibility, safety, and preliminary efficacy of home-based 60Hz intermittent light therapy in adults with a major depressive episode (MDE). Participants will be randomized in a 2:1 ratio to receive either active or sham 60Hz intermittent light stimulation for 30 minutes daily (Monday through Friday) over three weeks. The light is delivered through a wearable headset. Clinical assessments will be conducted remotely at baseline, mid-point, post-treatment, and follow-up to measure changes in depressive symptoms.

Official Title

A Feasibility Pilot Study of Home-Based Intermittent 60Hz Light Therapy for the Treatment of Depression

Quick Facts

Study Start:2025-08-18
Study Completion:2026-03-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07111390

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:24 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age between 24 and 65 years (inclusive)\*.
  2. * Confirmed diagnosis of Major Depressive Disorder (MDD), based on MINI interview.
  3. * Hamilton Depression Rating Scale (HDRS-17) score ≥17 at screening.
  4. * On a stable dose of antidepressant medication for at least 30 days prior to HDRS-17 screening.
  5. * No evidence of premorbid cognitive impairment, as demonstrated by a standard score \>85 on the WRAT-5 Reading Recognition Subtest.
  6. * Confirmed access to a local provider that has primary responsibility for the subjects' clinical care, and who is available for contact in case of increased subject risk due to depressive symptoms.
  7. * Able to provide informed consent and comply with study procedures.
  8. * Access to a quiet space suitable for home-based light stimulation sessions.
  9. * English speaking: All study materials and assessments are only validated in English
  1. * Presence of primary neurological or autoimmune disorders.
  2. * Presence of psychiatric comorbidities as determined by the MINI interview (e.g., anxiety disorders, OCD, PTSD, bipolar disorder, psychotic disorder).
  3. * Current or recent diagnosis of alcohol or substance use disorder.
  4. * History of bipolar disorder or any psychotic disorder.
  5. * Clinically significant suicidal ideation or behavior, based on clinician judgment and the Columbia-Suicide Severity Rating Scale (C-SSRS).
  6. * History of seizure disorder or epilepsy.
  7. * History of migraine, tinnitus, or photosensitivity.
  8. * Diagnosis of retinal disease, cataract, or other visual impairments that may interfere with light exposure.
  9. * Regular use of anti-inflammatory drugs or anticoagulants (e.g., clopidogrel).
  10. * Pregnancy and Breastfeeding: Currently pregnant, planning pregnancy during the study period, or breastfeeding

Contacts and Locations

Study Contact

Shayna Pehel
CONTACT
929-455-5104
Shayna.Pehel@nyulangone.org
Giuseppina Pilloni
CONTACT
929-455-5317
Giuseppina.Pilloni@nyulangone.org

Principal Investigator

Giuseppina Pilloni, PhD
PRINCIPAL_INVESTIGATOR
NYU Langone Health

Study Locations (Sites)

NYU Langone Health
New York, New York, 10017
United States

Collaborators and Investigators

Sponsor: NYU Langone Health

  • Giuseppina Pilloni, PhD, PRINCIPAL_INVESTIGATOR, NYU Langone Health

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-08-18
Study Completion Date2026-03-01

Study Record Updates

Study Start Date2025-08-18
Study Completion Date2026-03-01

Terms related to this study

Keywords Provided by Researchers

  • Brain stimulation
  • MDD
  • Depression
  • Light therapy
  • Wearable
  • Neuromodulation
  • Telehealth

Additional Relevant MeSH Terms

  • Depression
  • MDD
  • Major Depressive Disorder
  • Major Depressive Episode