Transcranial Photobiomodulation for Bipolar Depression
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorVielight Inc.
About this trial
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.
Eligibility criteria
Qualifiers
• Diagnosis of bipolar depression
Montgomery-Asberg Depression Rating Scale (MADRS) of 24 or higher
Capable of providing consent
Currently inpatient or outpatient
Disqualifiers
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)
Trial design
Treatments tested in this trial
- Vielight Neuro Rx Gamma
- Sham Device
Treatment groups
40 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov