Transcranial Photobiomodulation for Bipolar Depression

What this study is about

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 join (things the study team will check)

✅ You may be able to join 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 be able to join 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 this trial is running

• Providence Care Hospital, Kingston, Ontario, Canada