Light Therapy for Depression

Overseen By Kathryn Roecklein, PhD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Pittsburgh

Must be taking: SSRIs

Must not be taking: Psychotropics, Photosensitizers

Disqualifiers: Intellectual disability, Bipolar, Schizophrenia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 1 week

80 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this neuroimaging pilot study is to understand developmental differences in the impact of therapeutic wavelength light (blue light) versus a non-therapeutic wavelength (red light) on emotional brain function in depression. The main questions this study aims to answer are: * Does acute exposure to blue light (vs red light) stabilize emotional brain function in depressed individuals? * Are stabilizing effects of blue light (vs red light) stronger for blue light in adolescents than young adults? Participants will complete: * A magnetic resonance imaging brain scan, in which we will examine the effect of blue versus red light on emotional brain function at rest and in response to rewards and losses. * A pupillometry test of sensitivity to blue vs red light * Clinical interviews and surveys * Screening measures for drug and alcohol use, MRI safety, and current pregnancy \[if relevant\] * Home sleep tracking with sleep diary and actigraphy for one week

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you can continue taking stable SSRI medication if you've been on it for more than 2 months. Other psychotropic medications are not allowed.

What data supports the effectiveness of the treatment for depression?

Research shows that bright light therapy (BLT) is effective in treating both seasonal and non-seasonal depression, with effects comparable to some antidepressant medications. It works by adjusting the body's internal clock and affecting mood-related chemicals, and is generally safe with mild side effects. ^{1 2 3 4 5}

Is light therapy safe for humans?

Bright light therapy (BLT) is generally considered safe for humans, with studies showing it is well-tolerated and has minimal side effects, such as occasional blurring. It has been used effectively for conditions like seasonal affective disorder and bipolar depression, and is noted for its good tolerance even in special populations like pregnant women. ^{2 3 6 7 8}

How is light therapy different from other treatments for depression?

Light therapy, including blue and red light therapy, is unique because it is a non-drug treatment that uses specific wavelengths of light to influence brain activity and mood. Unlike traditional medications, it is non-invasive and can be administered without the need for retinal exposure, making it a low-risk option for treating depression. ^{1 4 8 9 10}

Research Team

Adriane M Soehner, PhD

Principal Investigator

University of Pittsburgh

Eligibility Criteria

This trial is for adolescents and young adults with depression who can read and write in English, have no severe medical or neurological issues, are not pregnant or nursing, and haven't had substance/alcohol problems recently. Participants must be right-handed, not color-blind, off most psychotropic meds except stable SSRIs, and able to maintain a regular sleep schedule.

Inclusion Criteria

I have been diagnosed with major depression.

If I am under 18, my parent or guardian can attend the initial medical interview with me.

Exclusion Criteria

I have been on a stable SSRI medication for over 2 months.

Unable to read and write in English

Intellectual disability

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Treatment

Participants undergo MRI scans and pupillometry tests to assess the impact of blue versus red light on emotional brain function.

1 week

1 visit (in-person)

Follow-up

Participants are monitored for any delayed effects of light exposure and complete additional surveys.

1-2 weeks

1 visit (virtual)

Treatment Details

Interventions

• Blue Light
• Red Light

Trial Overview The study tests the effects of blue light versus red light on emotional brain function using MRI scans while participants respond to rewards and losses. It also includes pupillometry to measure light sensitivity, clinical interviews, surveys about mood and health habits like sleep which is tracked at home for a week.

Participant Groups

Group I: Red Light then Blue Light Experimental Treatment 2 Interventions

Red light (640 nm) then Blue light (480 nm)

Group II: Blue then Red Light Experimental Treatment 2 Interventions

Blue light (480 nm) then Red light (640 nm)

Blue Light is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Bright Light Therapy for:

• Seasonal Affective Disorder (SAD)
• Non-seasonal depression
• Jet lag
• Sleep disorders

Approved in United States as Blue Light Therapy for:

• Seasonal Affective Disorder (SAD)
• Non-seasonal depression
• Circadian rhythm disorders

Approved in Canada as Phototherapy for:

• Seasonal Affective Disorder (SAD)
• Non-seasonal depression
• Sleep disorders

Who Is Running the Clinical Trial?

University of Pittsburgh

Lead Sponsor

Trials

1,820

Recruited

16,360,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Findings from Research

Photobiomodulation (PBM) using red and near-infrared light shows promise as a low-risk treatment for major depressive disorder (MDD), with studies indicating significant antidepressant effects comparable to traditional medications.

The proposed mechanism of action involves enhancing mitochondrial metabolism in brain cells, suggesting that PBM could improve brain function, although more research is needed to determine optimal treatment parameters and confirm its safety and efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial and systemic photobiomodulation for major depressive disorder: A systematic review of efficacy, tolerability and biological mechanisms. Caldieraro, MA., Cassano, P.[2019]

Bright light therapy (BLT) combined with antidepressants significantly reduced depression scores in patients with bipolar disorder after four and eight weeks, demonstrating its effectiveness in accelerating therapeutic response.

The study, involving 41 patients, suggests that BLT is a safe and clinically relevant treatment option for enhancing the effects of standard antidepressant therapy in bipolar depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of light therapy as adjunctive treatment in bipolar depression: A pilot study. Cuomo, A., Carmellini, P., Garo, ML., et al.[2023]

In a study of 32 outpatients with bipolar depression, bright light therapy (BLT) significantly improved depression scores compared to dim light, with response rates of 81% for BLT versus 19% for dim light.

BLT was found to be a safe add-on treatment, with similar side effects to dim light exposure, indicating its potential as an effective therapy for bipolar depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of bright light therapy in bipolar depression. Yorguner Kupeli, N., Bulut, NS., Carkaxhiu Bulut, G., et al.[2018]

Bright light therapy (BLT) is feasible and well-tolerated in an acute psychiatric inpatient setting, with a high adherence rate of 94% and minimal side effects.

Patients receiving BLT showed significant reductions in depressive symptoms and improvements in functioning, with five sessions appearing to be the optimal amount for treatment effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of Adjunctive Bright Light Therapy for Depressive Symptoms on an Acute Psychiatric Floor. Trinh, A., Jain, P., Sabahath, S., et al.[2023]

Bright-light therapy (BLT) is an effective treatment for Seasonal Affective Disorder (SAD) and non-seasonal depression, showing comparable efficacy to fluoxetine, especially in bipolar disorder, with effects noticeable within one week.

BLT is generally safe with mild side effects, making it a suitable option for various populations, including pregnant women and the elderly, but requires careful management to prevent manic episodes in bipolar patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bright Light as a Personalized Precision Treatment of Mood Disorders. Maruani, J., Geoffroy, PA.[2020]

In a study involving 20 healthy participants, a new bright light therapy (BLT) cabin showed no reports of headaches, which are a common side effect of conventional BLT devices.

While some participants experienced blurring of vision (21.1% prevalence), the absence of headaches suggests that this new technology may improve patient adherence to treatment for seasonal depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bright light therapy: Minimizing light induced side effects with an innovative light setup. Leichtfried, V., Kantner-Rumplmair, W., Bartenbach, C., et al.[2014]

In a pilot study involving 48 outpatients with major depressive disorder, Bright Light Therapy (BLT) significantly improved depressive symptoms after 3 weeks of daily treatment, with effects lasting for at least 4 weeks.

The study found no significant differences in the efficacy of BLT between patients with melancholic versus atypical features of depression, suggesting that BLT may be a versatile treatment option for various mood disorder subtypes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is there a difference in clinical efficacy of bright light therapy for different types of depression? A pilot study. Naus, T., Burger, A., Malkoc, A., et al.[2018]

Bright light therapy (BLT) showed significant antidepressant effects in three pregnant women, with a 33% improvement in depressive symptoms after 2 weeks and a 55% improvement after 4 weeks of treatment.

No side effects were reported during the BLT treatment, indicating it is a well-tolerated option for treating non-seasonal depression in pregnant women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Bright light therapy in pregnant women depression--3 case studies]. Krzystanek, M., Krupka-Matuszczyk, I.[2006]

In a study involving 49 participants with major depressive disorder (MDD), transcranial photobiomodulation (t-PBM) using low irradiance and low energy did not show significant efficacy compared to sham treatment, indicating that the current dosing may be insufficient for therapeutic effects.

The results suggest that a minimal dose threshold is necessary for t-PBM to be effective in treating MDD, similar to other neuromodulation techniques, highlighting the need for further research to determine optimal dosing parameters.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Very Low-Level Transcranial Photobiomodulation for Major Depressive Disorder: The ELATED-3 Multicenter, Randomized, Sham-Controlled Trial. Iosifescu, DV., Norton, RJ., Tural, U., et al.[2022]

Light therapy (LT) is widely recommended by office-based physicians, with 67.3% endorsing its use, particularly among psychiatrists (91.6%), indicating its acceptance as a treatment option for various disorders.

LT is considered appropriate for a range of conditions beyond seasonal affective disorder (SAD), including non-seasonal depression and jet lag, suggesting that its application could be expanded in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of Light Therapy by Office-Based Physicians. Winkler-Pjrek, E., Spies, M., Baldinger-Melich, P., et al.[2019]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Transcranial and systemic photobiomodulation for major depressive disorder: A systematic review of efficacy, tolerability and biological mechanisms. [2019]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Effectiveness of light therapy as adjunctive treatment in bipolar depression: A pilot study. [2023]

3. Ireland pubmed.ncbi.nlm.nih.gov

Efficacy of bright light therapy in bipolar depression. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Feasibility of Adjunctive Bright Light Therapy for Depressive Symptoms on an Acute Psychiatric Floor. [2023]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Bright Light as a Personalized Precision Treatment of Mood Disorders. [2020]

6. England pubmed.ncbi.nlm.nih.gov

Bright light therapy: Minimizing light induced side effects with an innovative light setup. [2014]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Is there a difference in clinical efficacy of bright light therapy for different types of depression? A pilot study. [2018]

8. Poland pubmed.ncbi.nlm.nih.gov

[Bright light therapy in pregnant women depression--3 case studies]. [2006]

9. United States pubmed.ncbi.nlm.nih.gov

Very Low-Level Transcranial Photobiomodulation for Major Depressive Disorder: The ELATED-3 Multicenter, Randomized, Sham-Controlled Trial. [2022]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Use of Light Therapy by Office-Based Physicians. [2019]