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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
60Hz Intermittent Light Therapy
DeviceIntermittent 60 Hz flickering white light delivered via a wearable headset.
Sham Light Therapy
DeviceConstant white light delivered via a wearable headset.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Active Home-Based Intermittent Light TherapyExperimental treatment 1 intervention
Group B: Sham Home-Based Light TherapySham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Proportion of Participants who Complete all Scheduled Sessions
Measure of retention; 15 sessions scheduled in total.
Time frame
Up to Week 32
Average Percentage of Completed Sessions
Measure of adherence; 15 sessions scheduled in total.
Time frame
Up to Week 33
Proportion of Participants who Discontinue due to Adverse Effects
Measure of tolerability.
Time frame
Up to Week 3Secondary outcomes
1
Change in Montgomery-Åsberg Depression Rating Scale (MADRS) Score
The MADRS is a 10-item assessment of depression; each item is rated on a 7-point scale from 0 to 6. The total score is the sum of responses and ranges from 0 to 60; higher scores indicate greater severity of depression.
Time frame
Baseline, Week 32
Change in Hamilton Depression Rating Scale (HDRS-17) Score
The HDRS-17 is a 17-item scale assessing the severity of depression. Most items are rated on a 5-point scale (0-4), with some using a 3-point scale (0-2). The total score is the sum of responses and ranges from 0-52; higher scores indicate greater severity of depression.
Time frame
Baseline, Week 33
Change in Patient Health Questionnaire (PHQ-9) Score
The PHQ-9 is a 9-item scale assessing the prevalence of depressive symptoms. Each item is rated on a 4-point Likert scale from 0 to 3. The total score is the sum of responses and ranges from 0-27; higher scores indicate greater prevalence of depressive symptoms.
Time frame
Baseline, Week 34
Change in Quick Inventory of Depressive Symptomatology-Self-Report (QIDS-SR) Score
The QIDS-SR is a 15-item scale assessing depressive symptoms over the previous 7 days. Each item is rated on a 4-point Likert scale from 0 to 3. The total score is the sum of responses and ranges from 0-45; higher scores indicate greater prevalence of depressive symptoms.
Time frame
Baseline, Week 3Sponsors and contacts
Click on the lead sponsor to view all of their trials.
NYU Langone Health
Lead sponsor
Syntropic Medical
Collaborator
Source ClinicalTrials.gov