Depression, MDD, Major Depressive Disorder, Major Depressive Episode
Conditions
Keywords
Brain stimulation, MDD, Depression, Light therapy, Wearable, Neuromodulation, Telehealth
Brief 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.
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
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.
Sponsors
Syntropic Medical
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
24 Years to 65 Years
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 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Participants who Complete all Scheduled Sessions | Up to Week 3 | Measure of retention; 15 sessions scheduled in total. |
| Average Percentage of Completed Sessions | Up to Week 3 | Measure of adherence; 15 sessions scheduled in total. |
| Proportion of Participants who Discontinue due to Adverse Effects | Up to Week 3 | Measure of tolerability. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Quick Inventory of Depressive Symptomatology-Self-Report (QIDS-SR) Score | Baseline, Week 3 | 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. |
| Change in Work and Social Adjustment Scale (WSAS) Score | Baseline, Week 3 | The WSAS is a 5-item scale assessing the impact of mental health on daily activities. Each item is rated on a 9-point Likert scale from 0 to 8. The total score is the sum of responses and ranges from 0-40; higher scores indicate more severe impairment on daily activities. |
| Change in Generalized Anxiety Disorder (GAD-7) Score | Baseline, Week 3 | The GAD-7 is a 7-item scale assessing the severity of generalized anxiety disorder. Each item is rated on a scale from 0 to 3. The total score is the sum of responses and ranges from 0-21 with higher scores indicating more severe anxiety. |
| Post-Study System Usability Questionnaire (PSSUQ) Score | Week 3 | The PSSUQ assesses the overall usability of the intervention; each of the 16 items is rated on a scale from 1-7. The total score is the sum of responses and ranges from 16 to 112; higher scores indicate greater usability of the intervention. |
| Change in Montgomery-Åsberg Depression Rating Scale (MADRS) Score | Baseline, Week 3 | 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. |
| Net Promoter Score (NPS) | Week 3 | The NPS is a single-item questionnaire asking participants how likely they are to recommend the intervention to a colleague. The total score ranges from 1-10; higher scores indicate greater likelihood of promoting the intervention. |
| Brief Blinding Questionnaire (BBQ) Score | Week 3 | After completing the intervention phase of the study, effectiveness of participant blinding will be assessed using a 3-item questionnaire. The outcome will be scored as the percentage of participants who correctly guess their blinding assignment. |
| Adverse Events | Week 3 | Incidence of spontaneously reported adverse events during the intervention period. Incidence and type will be reported in the Adverse Events section of the results. |
| System Usability Scale (SUS) Score | Week 3 | The SUS is a 10-item assessment of the usability of the intervention; the items are rated on a scale from 1-5. The total score is the sum of responses and ranges from 10 to 50; higher scores indicate greater usability of the intervention. |
| Change in Hamilton Depression Rating Scale (HDRS-17) Score | Baseline, Week 3 | 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. |
| Change in Patient Health Questionnaire (PHQ-9) Score | Baseline, Week 3 | 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. |
Countries
United States
Contacts
Primary ContactShayna Pehel
Backup ContactGiuseppina Pilloni
Outcome results
None listed