Feasibility of Home-Based Intermittent 60Hz Light Therapy for Major Depressive Disorder (MDD)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age24-65
SponsorNYU Langone Health
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- 60Hz Intermittent Light Therapy
- Sham Light Therapy
Treatment groups
40 Participants
are divided into 2 treatment groupsSponsors and collaborators
NYU Langone Health
Lead sponsor
Syntropic Medical
Collaborator
Source ClinicalTrials.gov