Transcranial Photobiomodulation for Bipolar Depression (NCT07510646) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Transcranial Photobiomodulation for Bipolar Depression
Canada40 participantsStarted 2026-07-01
Plain-language summary
This study the effectiveness and safety of light therapy device targeted at the brain using a wearable device, the Vielight RX Gamma as a treatment for bipolar depression. Up to forty patients with bipolar disorder will be enrolled into the study and will either receive active treatment with the Vielight RX Gamma or sham (inactive device). They will be administered the devices in clinic 5days/week for 6 weeks. Changes in disease symptoms, cognitive function, pain, quality of life and rest EEG changes will be assessed.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* • Diagnosis of bipolar depression
* Montgomery-Asberg Depression Rating Scale (MADRS) of 24 or higher
* Capable of providing consent
* Currently inpatient or outpatient
* Ability to communicate in spoken and written English fluently enough to complete the required study assessments
Exclusion Criteria:
* Currently in manic or mixed episode, as measured by Young Mania Rating Scale (YMRS) more than 8-10
* Currently psychotic
* Judged to be at serious and imminent suicidal risk
* Currently has alcohol or substance use disorder (meeting criteria in the past 1 months)
* Unstable medical conditions
* Inability to consent or to complete study procedures
* Changes in medications or use of augmentative devices and other interventions in the 4 weeks prior to the study
* Participation in other clinical research trials that may influence primary outcomes or adherence to the proposed study
* Current pregnancy or intention to become pregnant
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.