A randomized, double-blind, placebo-controlled, dose-finding Phase IIa clinical study was completed in patients with moderate to severe depression. The objective of the study was primarily to determine the effective dose and treatment period and secondarily to determine safety and improvement of quality of life.
The primary end-point was measured by changes in Montgomery-Åsberg Depression Rating Scale (MADRS). Secondary end-point included Hamilton Depression Rating (HAM-D) scale, Depression – Clinical Global Impressions (CGI) scale, and Quick Inventory of depressive Symptomatology (QIDS-SR)
Results of Phase IIa clinical study
Serdaxin dose of 5 mg, administered as twice daily schedule was effective. Sub-group analysis revealed that Serdaxin at the dose resulted in statistically significant improvement in patients with severe major depressive disorder.
Patients using Serdaxin did not exhibit side effects typically associated with existing SSRI’s
and SNRI’s – no sexual dysfunction, insomnia or weight gain was observed.
