Light Therapy for Depression

Overseen By Andrew Elliott, MD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: St. Jude Children's Research Hospital

Must not be taking: Photosensitizing medications

Disqualifiers: Total blindness, Significant impairment, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

98 Participants Needed

Trial Summary

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 cannot participate if you are taking photosensitizing medications (drugs that make your skin more sensitive to light).

What data supports the effectiveness of this treatment for depression?

Light therapy is effective for treating major depression, not just the seasonal type. It can boost the effects of antidepressants and help patients who don't respond well to drugs. It also shows promise for other conditions like bipolar depression and cognitive issues in ADHD. ^{1 2 3 4 5}

Is light therapy safe for treating depression?

Light therapy is generally considered safe for treating depression, with few side effects reported. Some studies mention minor issues like blurring, but these are not common. Clinicians should monitor for rare cases of mood changes or increased activity levels, especially at the start of treatment. ^{2 6 7 8 9}

How is light therapy different from other treatments for depression?

Light therapy is unique because it uses bright light exposure to help regulate the body's internal clock (circadian rhythm), which can improve mood and reduce depressive symptoms. Unlike medications, it is non-invasive and can be an alternative or complement to traditional antidepressants, especially for those who cannot tolerate or prefer not to use drugs. ^{3 10 11 12 13}

What is the purpose of this trial?

The participants are being asked to be in this clinical trial, a type of research study, because the participants are going to have a hematopoietic stem cell transplant (HSCT) in the near future. Participants that get HSCT's often get depression and/or suffer from depressive symptoms, tiredness, and sleep disturbances. Primary Objective To evaluate the efficacy of BL therapy for the treatment of depression in children and adolescents undergoing hematopoietic stem cell transplant. Secondary Objectives * To evaluate the temporal effect and magnitude of BL vs. DL therapy on depression in pediatric patients undergoing HSCT. * To evaluate the efficacy of BL therapy for the treatment of fatigue in children and adolescents undergoing hematopoietic stem cell transplant. * To evaluate the response of BL therapy versus DL on sleep quality. Exploratory Objectives * To compare incidence of positive delirium screenings between those receiving BL therapy versus DL * To evaluate participant and caregiver perceptions of the acceptability, ease of use, and risks/benefits of the use of Light Therapy Glasses during HSCT utilizing qualitative interviews.

Research Team

Andrew Elliott, MD

Principal Investigator

St. Jude Children's Research Hospital

Eligibility Criteria

This trial is for children and adolescents who are about to receive a hematopoietic stem cell transplant (HSCT) and may experience depression, fatigue, or sleep issues. Specific eligibility criteria details were not provided.

Inclusion Criteria

I or my primary caregiver can read and write in English or Spanish.

I am scheduled for a stem cell transplant from a donor in the next 7 to 10 days.

Participant/guardian is willing to sign informed consent

Exclusion Criteria

I am taking medication that increases my skin's sensitivity to light.

Inability or unwillingness of research participant or legal guardian/representative to give written informed consent

Any patient that, in the opinion of the primary investigator is not appropriate for the study

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive light therapy with either bright or dim blue-spectrum white light for 30 minutes each day for 28 days during their HSCT related hospital admission

4 weeks

Daily sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of depression, fatigue, and sleep quality

4 weeks

Treatment Details

Interventions

• Light Therapy

Trial Overview The study tests the effectiveness of Light Therapy using an Ayo wearable device to treat depression in pediatric patients undergoing HSCT. It compares Bright Light (BL) therapy with Dim Light (DL), also looking at effects on fatigue and sleep quality.

Participant Groups

Group I: Group 1-A bright blue-spectrum white light (BL Active Control 1 Intervention

Participants will receive therapy with bright blue-spectrum white light (BL) for up to thirty minutes each day for 28 days during their HSCT related hospital admission

Group II: Group 2- A dim blue-spectrum white light control (DL Active Control 1 Intervention

Participants will receive therapy with dim blue-spectrum white light control (DL) for up to thirty minutes each day for 28 days during their HSCT related hospital admission

Who Is Running the Clinical Trial?

St. Jude Children's Research Hospital

Lead Sponsor

Trials

451

Recruited

5,326,000+

Findings from Research

Light therapy is an effective, evidence-based treatment for Seasonal Affective Disorder, influencing circadian rhythms that affect sleep, mood, and cognition, based on 40 years of clinical trials.

For optimal results, light therapy should use devices that provide 10,000 lux of white light for 30-60 minutes in the early morning, with ongoing monitoring to adjust treatment as needed and manage any side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CME: Light Therapy: Why, What, for Whom, How, and When (And a Postscript about Darkness). Wirz-Justice, A., Terman, AM.[2022]

Light therapy, originally developed for seasonal affective disorder (SAD), has shown efficacy not only for SAD but also for other psychiatric conditions, including nonseasonal major depressive disorder and bipolar depression, particularly in cases resistant to traditional treatments.

Recent studies suggest that light therapy can improve cognitive function in adults with ADHD, enhance motor function in Parkinson's disease, and alleviate rest-activity disturbances in elderly patients with dementia, indicating its broad therapeutic potential.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evolving applications of light therapy. Terman, M.[2022]

Wake therapy is the fastest antidepressant treatment available, with about 60% of patients experiencing significant improvement within hours, and can be combined with light therapy or medications to prevent relapse.

Light therapy is effective for treating major depression, including non-seasonal types, and can enhance the effects of conventional antidepressants, making it a good option for patients who cannot tolerate medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chronotherapeutics (light and wake therapy) in affective disorders. Wirz-Justice, A., Benedetti, F., Berger, M., et al.[2019]

In a study involving 42 patients with major depressive disorder, both bright white-light therapy (2,500 lux) and dim red-light therapy (50 lux) were administered daily for seven days without any significant differences in side effects between the two treatments.

This suggests that light therapy, regardless of intensity, may be a safe option for treating depression without increasing the risk of adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Side-effects of phototherapy in nonseasonal depressive disorder. Volz, HP., Mackert, A., Stieglitz, RD.[2004]

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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

CME: Light Therapy: Why, What, for Whom, How, and When (And a Postscript about Darkness). [2022]

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

Comparison of venlafaxine alone versus venlafaxine plus bright light therapy combination for severe major depressive disorder. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Evolving applications of light therapy. [2022]

4. New Zealand pubmed.ncbi.nlm.nih.gov

Augmentation of light therapy in difficult-to-treat depressed patients: an open-label trial in both unipolar and bipolar patients. [2020]

5. England pubmed.ncbi.nlm.nih.gov

Chronotherapeutics (light and wake therapy) in affective disorders. [2019]

6. Germany pubmed.ncbi.nlm.nih.gov

Side-effects of phototherapy in nonseasonal depressive disorder. [2004]

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

Morning light treatment hastens the antidepressant effect of citalopram: a placebo-controlled trial. [2022]

8. England pubmed.ncbi.nlm.nih.gov

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

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

Light therapy for seasonal and nonseasonal depression: efficacy, protocol, safety, and side effects. [2022]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Sunny hospital rooms expedite recovery from severe and refractory depressions. [2022]

11. Sweden pubmed.ncbi.nlm.nih.gov

Bright light therapy. [2009]

12. Switzerland pubmed.ncbi.nlm.nih.gov

High circadian stimulus lighting therapy for depression: Meta-analysis of clinical trials. [2022]

13. Belgium pubmed.ncbi.nlm.nih.gov

[Bright light therapy]. [2015]