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
This trial does not accept healthy volunteersQualifiers
• 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
Design model
Parallel
Treatments tested in this trial
Vielight Neuro Rx Gamma
DeviceParticipants assigned to the intervention will be administered treatment with the Neuro Rx Gamma 5 days/week in clinic
Sham Device
DeviceParticipant assigned to the sham device will be administered the sham device in clinic 5 days/week
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Sham (inactive Neuro Rx Gamma)Sham comparator 1 intervention
Group B: Neuro Rx GammaExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Montgomery-Asberg Depression Rating Scale (MADRS)
Change in depression symptoms as measured by the Montgomery-Asberg Depression ( Rating Scale (MADRS). Scale is from 0-60, with higher score indicating high depression severity.
Time frame
Baseline to week 6Secondary outcomes
1
Clinical Global Impression Scale-Bipolar
Change in Clinical Global Impression Scale-Bipolar (CGI-BP). Scale from 1-7 with a higher means more severe illness.
Time frame
Change from baseline to week 62
Trails Making Test
Change in score of the Trails Making Test. Scored based on the total time in seconds it takes to complete each part, meaning a lower score is better and a higher score indicates greater cognitive impairment.
Time frame
Baseline to week 63
N-Back (2-Back)
Change in performance in N-Back (2-back)
Time frame
Baseline to week 64
World Health Disability Assessment Schedule 2.0 (WHODAS 2.0)
Change in quality of life as measured by the World Health Disability Assessment Schedule 2.0 (WHODAS 2.0). Scores range from 0 to 100, where higher scores indicate greater disability.
Time frame
Baseline to week 6Other outcomes
1
Device-related adverse events
Mean difference in device related adverse events between active and sham groups
Time frame
Baseline to week 6Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
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