Transcranial Photobiomodulation for Bipolar Depression
Starting soon · Not applicable · Has a placebo group
Conditions studied: Bipolar, Bipolar Disorder (BD), Bipolar Disorder Depression
In brief
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.
Key facts
- Study ID
- NCT07510646
- Run by
- Vielight Inc.
- People needed
- 40
- Starts
- 2026-07-01
- Expected to finish
- 2027-07-01
- Last updated by the study team
- 2026-04-03
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- • 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
You may not qualify if…
- 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
Where it is running
- Providence Care Hospital — Kingston, Ontario, Canada
Full record on ClinicalTrials.gov
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