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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 and 45 weeks
Awards & highlights
BPII-DEP-LT Trial 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.Check my eligibility
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.See study design
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.
BPII-DEP-LT Trial 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.
BPII-DEP-LT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 and 45 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 and 45 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
the response rate as defined by a 50% improvement of the depressive symptoms score on the MADRS scale
Secondary outcome measures
the incidence of side-effects as per the UKU scale
the quality of life as per SF-36 and Q-LES-Q SF scales
the relapse rate into depression or hypomania
+2 moreBPII-DEP-LT 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
2,676 Total Patients Enrolled
National Alliance for Research on Schizophrenia and DepressionOTHER
96 Previous Clinical Trials
4,079 Total Patients Enrolled
Serge Beaulieu, Ph.D.Principal InvestigatorMcGill University
1 Previous Clinical Trials
36 Total Patients Enrolled
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Would I meet the criteria for participation in this research?
"To be eligible to join this medical trial, individuals must have a diagnosis of depression or bipolar disorder and should fall between 18-70 years old. 50 patients are being sought for the study as a whole."
Answered by AI
Is it mandatory for applicants to have surpassed the age of 65 in order to join this trial?
"According to the conditions for participation of this study, those aged 18-70 are considered eligible. There is a total 205 trials accessible to minors and 1066 studies available for seniors."
Answered by AI
Is there availability for potential participants in this medical experiment?
"As per the information on clinicaltrials.gov, this particular assessment is not currently accepting applicants. The trial was first shared on January 1st 2008 and last edited on February 17th 2023; however, 1426 other trials are actively recruiting individuals."
Answered by AI
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