The primary objectives of this Phase II study are to demonstrate the safety of Nexalin Therapy and to investigate the efficacy of Nexalin Therapy.
This randomized, double-blind, placebo-controlled, multi-center trial has 3 different treatment arms. Study Tools: * Hamilton Depression Rating Scale (HAM-D21) * Clinical Global Impressions (CGI) * Montgomery-Asberg Depression Rating Scale (MADRS) * Beck's Depression Inventory * Hamilton Anxiety Rating Scale (HAM-A) * Hospital Anxiety and Depression Scale (HADS)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
120
* 3 treatment cycles (cycle is 5 daily treatments, followed by 2 days off) * Daily receipt of placebo antidepressant
* 3 treatment cycles (cycle is 5 daily treatments, followed by 2 days off) * Daily receipt of a placebo antidepressant
* 3 treatment cycles (cycle is 5 daily treatments, followed by 2 days off) * Daily receipt of a a SSRI (Citalopram or similar)
Leningrad Regional Center of Addiction
Saint Petersburg, Vsevolozhsky District, Russia
St. Petersburg City Center of Neuroses
Saint Petersburg, Russia
Hamilton Depression Rating Scale (HAM-D21)
Time frame: Screening; Baseline; Treatments 5, 10, & 15; Follow-up Weeks 2, 4, 8, & 12
Clinical Global Impression (CGI)
Time frame: Screening; Baseline; Treatments 5, 10, & 15; Follow-up Weeks 2, 4, 8, & 12
Montgomery-Asberg Depression Rating Scale (MADRS)
Time frame: Screening; Baseline; Treatments 5, 10, & 15; Follow-up Weeks 2, 4, 8, & 12
Beck's Depression Inventory
Time frame: Screening; Baseline; Treatments 5, 10, & 15; Follow-up Weeks 2, 4, 8, & 12
Hamilton Anxiety Rating Scale (HAM-A)
Time frame: Screening; Baseline; Treatments 5, 10, & 15; Follow-up Weeks 2, 4, 8, & 12
Hospital Anxiety and Depression Scale (HADS)
Time frame: Screening; Baseline; Treatments 5, 10, & 15; Follow-up Weeks 2, 4, 8, & 12
Medication Usage Log
Time frame: Every visit
Adverse Event Log
Time frame: Every visit
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.