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

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this study is to evaluate the efficacy and safety of light therapy for the treatment of bipolar type II patients relapsing into a depressive phase during autumn or winter.

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.

Is bright or dim light therapy safe for humans, especially for those with bipolar disorder?

Bright light therapy has been used for 30 years and is generally considered safe and well-tolerated for conditions like seasonal affective disorder. Studies on its use for bipolar disorder also suggest it is safe, though monitoring for hypomanic symptoms (mild mania) is important to ensure tolerance. ^{1 2 3 4 5}

How does bright light therapy differ from other treatments for bipolar disorder depression?

Bright light therapy is unique because it uses exposure to bright light as a non-drug treatment to improve mood in bipolar depression, similar to its use in seasonal affective disorder (SAD). It is simple to administer, has a favorable side-effect profile compared to medications, and can be used alongside other treatments to enhance their effects. ^{1 2 6 7 8}

What data supports the effectiveness of this treatment for bipolar disorder depression?

Research shows that bright light therapy (BLT) can significantly improve symptoms in people with bipolar depression, similar to its effectiveness in treating seasonal affective disorder (SAD). Studies have found that patients with bipolar disorder who received BLT experienced significant improvements in mood, and these benefits were maintained for several months. ^{1 2 3 4 9}

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.

Deficit in vitamin B12 or folate

History of light-induced migraine or epilepsy

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. 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]

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

Effects of phototherapy on non-seasonal unipolar and bipolar depressive spectrum disorders. [2019]

3. Korea (South) pubmed.ncbi.nlm.nih.gov

Bright Light Therapy in the Morning or at Mid-Day in the Treatment of Non-Seasonal Bipolar Depressive Episodes (LuBi): Study Protocol for a Dose Research Phase I / II Trial. [2020]

4. England pubmed.ncbi.nlm.nih.gov

Mood and behavioral effects of four-week light treatment in winter depressives and controls. [2019]

5. Ireland pubmed.ncbi.nlm.nih.gov

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

6. Netherlands pubmed.ncbi.nlm.nih.gov

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

7. Germany pubmed.ncbi.nlm.nih.gov

Treating winter depressive episodes in bipolar disorder: an open trial of light therapy. [2023]

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

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

9. Sweden pubmed.ncbi.nlm.nih.gov

Bright light therapy. [2009]