A Feasibility Pilot Study of Home-Based Intermittent 60Hz Light Therapy for the Treatment of Depression
NYU Langone Health
Summary
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.
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.
Eligibility
- Age range
- 24–65 years
- Sex
- All
- Healthy volunteers
- No
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 incr…
Interventions
- Device60Hz Intermittent Light Therapy
Intermittent 60 Hz flickering white light delivered via a wearable headset.
- DeviceSham Light Therapy
Constant white light delivered via a wearable headset.
Location
- NYU Langone HealthNew York, New York