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Light Therapy
Bright vs Dim Light Therapy for Bipolar Disorder Depression (BPII-DEP-LT Trial)
N/A
Waitlist Available
Led By Serge Beaulieu, Ph.D.
Research Sponsored by Douglas Mental Health University Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Hamilton Depression Rating Scale 21 items (HAMD-21) ≥ 17 and a Montgomery Asberg rating Scale (MADRS) ≥ 15 for at least 2 weeks and the episode has begun during the month of September or a later month
Be older than 18 years old
Must not have
Sub-syndromic hypomania symptoms as per a Young Mania Rating Scale (YMRS) score ≥ 4
Known skin sensitivity to sunlight, especially in patients receiving photosensitizing drugs such as lithium or phenothiazines
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Summary
This trial looks at if light therapy can treat bipolar type II patients who are relapsing into depression in autumn/winter.
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects may include eyestrain, headache, irritability or agitation due to exposure to bright/dim lights. There's also a risk of inducing hypomanic or manic episodes in susceptible individuals.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been significantly depressed since September, confirmed by tests.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My mood has been unusually elevated, as shown by a YMRS score of 4 or higher.
Select...
I am sensitive to sunlight and take medication that increases this sensitivity.
Select...
I do not have untreated mental health issues or unstable conditions like heart disease or diabetes.
Select...
I am not pregnant and am using birth control.
Select...
I am blind due to a retinal condition or have severe cataracts.
Select...
I have undergone light therapy in the past.
Select...
I have glaucoma or a retinal disease.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: 1Experimental Treatment1 Intervention
Group II: 2Placebo Group1 Intervention
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Who is running the clinical trial?
Douglas Mental Health University InstituteLead Sponsor
29 Previous Clinical Trials
2,698 Total Patients Enrolled
4 Trials studying Bipolar Disorder
134 Patients Enrolled for Bipolar Disorder
National Alliance for Research on Schizophrenia and DepressionOTHER
96 Previous Clinical Trials
4,079 Total Patients Enrolled
19 Trials studying Bipolar Disorder
1,239 Patients Enrolled for Bipolar Disorder
Serge Beaulieu, Ph.D.Principal InvestigatorMcGill University
1 Previous Clinical Trials
36 Total Patients Enrolled
1 Trials studying Bipolar Disorder
36 Patients Enrolled for Bipolar Disorder
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.I do not have untreated mental health issues or unstable conditions like heart disease or diabetes.I am not pregnant and am using birth control.I am willing and able to consent to participate in the study.I am blind due to a retinal condition or have severe cataracts.I have been significantly depressed since September, confirmed by tests.I have undergone light therapy in the past.I have glaucoma or a retinal disease.
Research Study Groups:
This trial has the following groups:- Group 1: 2
- Group 2: 1
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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