DepressionNCT07111390
Feasibility of Home-Based Intermittent 60Hz Light Therapy for Major Depressive Disorder (MDD)
A study testing 60Hz Intermittent Light Therapy in people with Depression and MDD, run by NYU Langone Health at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 24 to 65 years
- Conditions the study is for
- Depression, MDD, Major Depressive Disorder
- What is being tested?
- 60Hz Intermittent Light Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Aug 2025to 1 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 24 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Feasibility Pilot Study of Home-Based Intermittent 60Hz Light Therapy for the Treatment of Depression
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.
Read the 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.
- Conditions
- Depression, MDD, Major Depressive Disorder, Major Depressive Episode
- Being tested
- 60Hz Intermittent Light Therapy, Sham Light Therapy
- Keywords
- Brain stimulation, MDD, Depression, Light therapy, Wearable, Neuromodulation, Telehealth
- Medical subject headings
- Depression, Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
60Hz Intermittent Light TherapyDevice
Intermittent 60 Hz flickering white light delivered via a wearable headset.
Sham Light TherapyDevice
Constant white light delivered via a wearable headset.
| Study group | Role | What they receive |
|---|---|---|
| Active Home-Based Intermittent Light Therapy | Experimental | Adults with a major depressive episode (MDE) randomized to receive active home-based 60Hz intermittent light therapy, delivered five days per week for three weeks for a total of 15x30-minute daily sessions. Receives: Device: 60Hz Intermittent Light Therapy |
| Sham Home-Based Light Therapy | Sham comparator | Adults with a major depressive episode (MDE) randomized to receive sham home-based light therapy, delivered five days per week for three weeks for a total of 15x30-minute daily sessions. Receives: Device: Sham Light Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Participants who Complete all Scheduled Sessions
Measure of retention; 15 sessions scheduled in total.
Measured: Up to Week 3
Average Percentage of Completed Sessions
Measure of adherence; 15 sessions scheduled in total.
Measured: Up to Week 3
Proportion of Participants who Discontinue due to Adverse Effects
Measure of tolerability.
Measured: Up to Week 3
Secondary outcomes (11)
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.
Measured: Baseline, Week 3
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.
Measured: Baseline, Week 3
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.
Measured: Baseline, Week 3
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.
Measured: Baseline, Week 3
Change in Work and Social Adjustment Scale (WSAS) Score
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.
Measured: Baseline, Week 3
Change in Generalized Anxiety Disorder (GAD-7) Score
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.
Measured: Baseline, Week 3
Post-Study System Usability Questionnaire (PSSUQ) Score
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.
Measured: Week 3
System Usability Scale (SUS) Score
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.
Measured: Week 3
Net Promoter Score (NPS)
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.
Measured: Week 3
Brief Blinding Questionnaire (BBQ) Score
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.
Measured: Week 3
Adverse Events
Incidence of spontaneously reported adverse events during the intervention period. Incidence and type will be reported in the "Adverse Events" section of the results.
Measured: Week 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2025
- Study start18 Aug 2025
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- Syntropic Medical
- Responsible party
- Sponsor
- Investigators
- Giuseppina Pilloni, PhD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07111390
- Sponsor's protocol ID
- 25-00522
- Status last verified
- Nov 2026
- First submitted
- 1 Aug 2025
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Individual participant data (IPD) will not be shared due to the small sample size and risk of re-identification, as well as the exploratory nature of the pilot study.
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Pilot Study of Home-Based Intermittent 60Hz Light Therapy for the Treatment of Depression
- ClinicalTrials.gov ID
- NCT07111390
- Acronym / sponsor ID
- 25-00522
- Conditions
- Depression, MDD, Major Depressive Disorder, Major Depressive Episode
- Keywords
- Brain stimulation, MDD, Depression, Light therapy, Wearable, Neuromodulation, Telehealth
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 44 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- Syntropic Medical
- Study start
- 18 Aug 2025 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 8 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Home-Based Intermittent Light Therapy | Experimental | Device: 60Hz Intermittent Light TherapyAdults with a major depressive episode (MDE) randomized to receive active home-based 60Hz intermittent light therapy, delivered five days per week for three weeks for a total of 15x30-minute daily sessions. |
| Sham Home-Based Light Therapy | Sham comparator | Device: Sham Light TherapyAdults with a major depressive episode (MDE) randomized to receive sham home-based light therapy, delivered five days per week for three weeks for a total of 15x30-minute daily sessions. |
Who may qualify
- Ages
- 24 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (10 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 60Hz Intermittent Light TherapyIntermittent 60 Hz flickering white light delivered via a wearable headset. | Device | Active Home-Based Intermittent Light Therapy |
| Sham Light TherapyConstant white light delivered via a wearable headset. | Device | Sham Home-Based Light Therapy |
Primary outcome
Proportion of Participants who Complete all Scheduled Sessions
Time frame: Up to Week 3
Measure of retention; 15 sessions scheduled in total.
Average Percentage of Completed Sessions
Time frame: Up to Week 3
Measure of adherence; 15 sessions scheduled in total.
Proportion of Participants who Discontinue due to Adverse Effects
Time frame: Up to Week 3
Measure of tolerability.
11 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared due to the small sample size and risk of re-identification, as well as the exploratory nature of the pilot study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giuseppina Pilloni, PhD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 60Hz Intermittent Light Therapy in people with Depression and MDD, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Participants who Complete all Scheduled Sessions (time frame: Up to Week 3). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.