Bright vs Dim Light Therapy for Bipolar Disorder Depression

(BPII-DEP-LT Trial)

Overseen By Sybille Saury

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Douglas Mental Health University Institute

Must not be taking: Photosensitizing drugs

Disqualifiers: Other psychiatric condition, diabetes, hypertension, alcohol or drug abuse, others

Compensation: Varies

Number of Visits: Unknown

Duration: 5 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test whether bright light therapy can help individuals with bipolar disorder type II who experience depression during the fall and winter months. Participants will use either a bright light therapy lamp or a placebo (inactive treatment) to determine if it improves mood and overall well-being. The trial seeks individuals diagnosed with bipolar type II who are currently experiencing a depressive episode that began in September or later. Participants should not have other psychiatric conditions or medical issues such as untreated diabetes or high blood pressure.

As an unphased trial, this study offers a unique opportunity to contribute to understanding how bright light therapy might benefit those with bipolar disorder type II.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. However, if you are taking photosensitizing drugs like lithium or phenothiazines, you may not be eligible to participate.

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

Research has shown that bright light therapy, such as using the Northern Light Technology SADelite lamp, has been safely used for about 30 years. It effectively treats conditions like seasonal affective disorder (SAD). Studies have found it generally safe, with very few experiencing serious side effects. Some might encounter mild issues like headaches or eye strain, but these are uncommon. Overall, bright light therapy is considered a safe option for many managing mood-related conditions. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard treatments for bipolar disorder depression, which often involve medication like mood stabilizers and antipsychotics, bright light therapy uses a non-drug approach. This treatment is unique because it harnesses bright light to potentially improve mood and regulate sleep cycles. Researchers are excited about this therapy as it offers a novel mechanism of action that doesn’t rely on adjusting brain chemicals through medication. Additionally, it might provide a quicker onset of relief and help reduce side effects associated with traditional pharmacological treatments.

What evidence suggests that this trial's treatments could be effective for bipolar disorder depression?

Research shows that bright light therapy (BLT), which participants in this trial may receive, can greatly help people with bipolar depression. Studies have found that those using BLT experienced a noticeable decrease in depression symptoms compared to those using dim light therapy, another treatment option in this trial. This indicates that BLT effectively reduces depressive symptoms in bipolar disorder. Additionally, reviews of multiple studies confirm that BLT is both effective and safe for treating these symptoms. Overall, the evidence strongly supports BLT as a promising treatment for bipolar depression during the darker months. ^{2 3 6 7 8}

Who Is on the Research Team?

Serge Beaulieu, Ph.D.

Principal Investigator

McGill University

Are You a Good Fit for This Trial?

This trial is for individuals with Bipolar Type II disorder experiencing a depressive phase, as defined by specific clinical scales. They must have symptoms that started in autumn or winter and be willing to consent to the study. Excluded are those with other psychiatric conditions, unstable medical issues, certain vitamin deficiencies, risk of light-induced mania or migraines, pregnancy without contraception, severe eye diseases, substance abuse problems, or past light therapy use.

Inclusion Criteria

Bipolar type II disorder, depressive phase meeting DSM-IV criteria as per the SCID interview

I am willing and able to consent to participate in the study.

I have been significantly depressed since September, confirmed by tests.

Exclusion Criteria

My mood has been unusually elevated, as shown by a YMRS score of 4 or higher.

I am sensitive to sunlight and take medication that increases this sensitivity.

Deficit in vitamin B12 or folate

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive daily morning light therapy for 30 minutes over 5 weeks

5 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Open-label extension (optional)

Participants may continue light therapy beyond 5 weeks to assess long-term benefits

Long-term

What Are the Treatments Tested in This Trial?

Interventions

• Northern Light Technology (SADelite lamp) bright light-therapy
• Northern Light Technology (SADelite lamp) Dim light-therapy

Trial Overview

The study tests the effectiveness and safety of bright versus dim light therapy using Northern Light Technology lamps on patients with Bipolar Type II depression during fall/winter months. Participants will receive either bright light-therapy or dim light-therapy to determine if there's an improvement in their depressive symptoms.

How Is the Trial Designed?

Group I: 1 Experimental Treatment 1 Intervention

Group II: 2 Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Douglas Mental Health University Institute

Lead Sponsor

Trials

31

Recruited

2,800+

National Alliance for Research on Schizophrenia and Depression

Collaborator

Trials

97

Recruited

4,100+

Published Research Related to This Trial

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) 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]

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/29268206/

Efficacy of Bright Light Therapy in Bipolar Depression

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withpower.com

withpower.com/trial/phase-bipolar-disorder-2008-7946b

Bright vs Dim Light Therapy for Bipolar Disorder Depression

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7187384/

Efficacy and safety of bright light therapy for manic and ...

This systematic review and meta‐analysis evaluated whether bright light therapy (BLT) is an effective and safe treatment for manic/depressive symptoms

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community.the-hospitalist.org

community.the-hospitalist.org/content/bright-light-therapy-bipolar-depression-review-6-studies

Bright light therapy for bipolar depression: A review of 6 ...

The primary outcomes were depression severity, efficacy of duration/timing of BLT for depressive symptoms, and efficacy of different light ...

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grantome.com

grantome.com/grant/NIH/K23-MH082114-01A2

Efficacy of Bright Light Therapy Vs. Placebo for Bipolar ...

The hypotheses are: 1) greater improvement in depression will occur with active vs. inactive light between Weeks 0 and 6;2) a greater proportion of patients ...

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northernlighttechnologies.com

northernlighttechnologies.com/

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Lift your mood with 10000 Lux light therapy lamps. Made in Canada and recommended by top SAD clinicians since 1989.

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Northern Light Technologies SADelite Desk Lamp

A bright light therapy product which delivers bright light by combining high-output fluorescent tubes with a large high-performance parabolic reflector.

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SAD Light Therapy: Benefits and Side Effects ...

They can determine if light therapy is safe and helpful for you to try. For many people, bright light therapy is safe and effective. But light therapy may ...