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Recruiting NCT07111390

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

No phase Interventional Depression MDD Major Depressive Disorder Major Depressive Episode

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 60Hz Intermittent Light Therapy, Sham Light Therapy.
Who it may be relevant to
Registry conditions: Depression, MDD, Major Depressive Disorder, Major Depressive Episode. Basic parameters: 24 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Detailed description

This pilot study will evaluate the tolerability, usability, and preliminary impact of a novel wearable device delivering 60Hz intermittent light for treatment of depressive symptoms in adults with MDD. All procedures are conducted remotely.

Interventions

  • Device 60Hz Intermittent Light Therapy
    Intermittent 60 Hz flickering white light delivered via a wearable headset.
  • Device Sham Light Therapy
    Constant white light delivered via a wearable headset.

Primary outcome measures

  • Proportion of Participants who Complete all Scheduled Sessions [Time frame: Up to Week 3]
  • Average Percentage of Completed Sessions [Time frame: Up to Week 3]
  • Proportion of Participants who Discontinue due to Adverse Effects [Time frame: Up to Week 3]
Secondary outcome measures (11)
  • Change in Montgomery-Åsberg Depression Rating Scale (MADRS) Score [Time frame: Baseline, Week 3]
  • Change in Hamilton Depression Rating Scale (HDRS-17) Score [Time frame: Baseline, Week 3]
  • Change in Patient Health Questionnaire (PHQ-9) Score [Time frame: Baseline, Week 3]
  • Change in Quick Inventory of Depressive Symptomatology-Self-Report (QIDS-SR) Score [Time frame: Baseline, Week 3]
  • Change in Work and Social Adjustment Scale (WSAS) Score [Time frame: Baseline, Week 3]
  • Change in Generalized Anxiety Disorder (GAD-7) Score [Time frame: Baseline, Week 3]
  • Post-Study System Usability Questionnaire (PSSUQ) Score [Time frame: Week 3]
  • System Usability Scale (SUS) Score [Time frame: Week 3]
  • Net Promoter Score (NPS) [Time frame: Week 3]
  • Brief Blinding Questionnaire (BBQ) Score [Time frame: Week 3]
  • Adverse Events [Time frame: Week 3]

Eligibility criteria

Inclusion criteria

  • Age between 24 and 65 years (inclusive)\*.
  • Confirmed diagnosis of Major Depressive Disorder (MDD), based on MINI interview.
  • Hamilton Depression Rating Scale (HDRS-17) score ≥17 at screening.
  • On a stable dose of antidepressant medication for at least 30 days prior to HDRS-17 screening.
  • No evidence of premorbid cognitive impairment, as demonstrated by a standard score >85 on the WRAT-5 Reading Recognition Subtest.
  • 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.
  • Able to provide informed consent and comply with study procedures.
  • Access to a quiet space suitable for home-based light stimulation sessions.
  • English speaking: All study materials and assessments are only validated in English

Exclusion criteria

  • Presence of primary neurological or autoimmune disorders.
  • Presence of psychiatric comorbidities as determined by the MINI interview (e.g., anxiety disorders, OCD, PTSD, bipolar disorder, psychotic disorder).
  • Current or recent diagnosis of alcohol or substance use disorder.
  • History of bipolar disorder or any psychotic disorder.
  • Clinically significant suicidal ideation or behavior, based on clinician judgment and the Columbia-Suicide Severity Rating Scale (C-SSRS).
  • History of seizure disorder or epilepsy.
  • History of migraine, tinnitus, or photosensitivity.
  • Diagnosis of retinal disease, cataract, or other visual impairments that may interfere with light exposure.
  • Regular use of anti-inflammatory drugs or anticoagulants (e.g., clopidogrel).
  • Pregnancy and Breastfeeding: Currently pregnant, planning pregnancy during the study period, or breastfeeding

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • NYU Langone Health — New York

Identifiers

NCT: NCT07111390 · 25-00522

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗