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New treatment option for Depression
Official title Feasibility of Home-Based Intermittent 60Hz Light Therapy for Major Depressive Disorder (MDD)
ClinicalTrials.gov ID: NCT07111390
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 24 to 65
You may be able to join if
- 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.
You likely can't join if
- 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.
See the full eligibility 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 people' 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- New York, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 24 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New York, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.