40 Participants Needed

Light Therapy for Depression

SP
GP
Overseen ByGiuseppina Pilloni
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: NYU Langone Health
Must be taking: Antidepressants
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new light therapy for individuals experiencing a major depressive episode. Participants will use a wearable headset at home, receiving either real or sham light therapy (60Hz Intermittent Light Therapy or Sham Light Therapy) for 30 minutes each day, from Monday to Friday, over three weeks. The trial aims to determine if the light therapy is safe and effective in reducing depression symptoms. This study may suit adults diagnosed with major depressive disorder who are on a stable dose of antidepressant medication. As an unphased trial, it offers participants the chance to contribute to innovative research that could lead to new treatment options for depression.

Do I need to stop my current medications to join the trial?

The trial does not specify that you need to stop your current medications. However, you must be on a stable dose of antidepressant medication for at least 30 days before joining.

What prior data suggests that this light therapy is safe for treating depression?

Research has shown that 60Hz intermittent light therapy is under study for its safety and effectiveness in treating depression. Earlier studies found that participants generally tolerated this type of light therapy well, with no major side effects reported.

The therapy involves a wearable headset that flashes light in short bursts. Early findings indicate only mild side effects, such as slight eye strain or headaches, which are common with light-based treatments. These effects are usually temporary and resolve on their own.

Ongoing research aims to confirm the safety of this light therapy for individuals with major depression. While more data is needed, early results appear promising for those considering participation in such trials.12345

Why are researchers excited about this trial?

Researchers are excited about 60Hz Intermittent Light Therapy for depression because it offers a non-invasive alternative to traditional treatments like antidepressant medications and psychotherapy. Unlike these options, this light therapy uses specific frequencies of light delivered in the comfort of a patient's home, potentially making it more accessible and convenient. Additionally, while most antidepressants can take weeks to show effectiveness, light therapy has the potential to deliver noticeable improvements more quickly, which is particularly promising for those seeking faster relief from depressive symptoms.

What evidence suggests that 60Hz intermittent light therapy is effective for depression?

Research shows that 60Hz intermittent light therapy, which participants in this trial may receive, might help treat depression. Studies have found that this light therapy is safe and well-tolerated by people with major depressive disorder. Animal studies suggest it could also improve mood. Additionally, a study where participants knew they were receiving the therapy found it to be a safe way to manage depression symptoms. While more research is needed to confirm its effectiveness, early results are promising.13678

Who Is on the Research Team?

GP

Giuseppina Pilloni, PhD

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

Adults with Major Depressive Disorder (MDD) experiencing a major depressive episode can join this study. They'll use a light therapy headset at home for three weeks. People who have other mental health disorders, eye diseases sensitive to light, or are taking medications affecting light sensitivity cannot participate.

Inclusion Criteria

Hamilton Depression Rating Scale (HDRS-17) score ≥17 at screening
I am between 24 and 65 years old.
I have been diagnosed with Major Depressive Disorder.
See 6 more

Exclusion Criteria

I have a neurological or autoimmune disorder.
Pregnancy and Breastfeeding: Currently pregnant, planning pregnancy during the study period, or breastfeeding
Presence of psychiatric comorbidities as determined by the MINI interview (e.g., anxiety disorders, OCD, PTSD, bipolar disorder, psychotic disorder)
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either active or sham 60Hz intermittent light stimulation for 30 minutes daily, five days per week, over three weeks

3 weeks
Remote assessments at baseline, mid-point, and post-treatment

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week
Remote assessment

What Are the Treatments Tested in This Trial?

Interventions

  • 60Hz Intermittent Light Therapy
  • Sham Light Therapy
Trial Overview The trial is testing if using a special headset that gives off 60Hz intermittent light can help with depression symptoms when used daily at home for 30 minutes. Participants will be randomly assigned to get either the real treatment or a fake (sham) version without knowing which one they're getting.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Active Home-Based Intermittent Light TherapyExperimental Treatment1 Intervention
Group II: Sham Home-Based Light TherapyPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials
1,431
Recruited
838,000+

Syntropic Medical

Collaborator

Citations

Feasibility of Home-Based Intermittent 60Hz Light Therapy ...This pilot study evaluates the feasibility, safety, and preliminary efficacy of home-based 60Hz intermittent light therapy in adults with a major depressive ...
IWLS for Major Depressive Disorder: An Open-Label Study ...This is an open-label study designed to assess the safety and tolerability of 60 Hz intermittent light stimulation (ILS) in individuals with ...
IWLS for Major Depressive Disorder: An Open-Label Study of ...In this context, 60 Hz intermittent light stimulation may represent a promising and safe treatment option for depression. Animal studies have demonstrated that ...
EPP558 Intermittent white light at 60Hz, a novel non ...Conclusions: After six weeks of antidepressant treatment, the treatment responder rate among all depression patients was. 11.33%, with better outcomes observed ...
Feasibility of Home-Based Intermittent 60Hz Light Therapy ...This pilot study evaluates the feasibility, safety, and preliminary efficacy of home-based 60Hz intermittent light therapy in adults with a ...
Light Therapy for DepressionThis pilot study evaluates the feasibility, safety, and preliminary efficacy of home-based 60Hz intermittent light therapy in adults with a major depressive ...
A Feasibility Pilot Study of Home-Based Intermittent 60Hz ...The purpose of this study is to see how easy it is to use an intermittent light therapy device in adults with a major depressive episode (MDE), ...
Improvement in Depression Scores After 1 Hour of Light ...A significant but modest improvement was detected after a single active light session. This is the first study, to our knowledge, to document an immediate ...
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