Safety, Tolerability, PK Profile, and Symptom Response of a 7-Day Dosing With 25 mg or 50 mg Daily of REL-1017 in MDD
Status:
Completed
Trial end date:
2019-09-30
Target enrollment:
Participant gender:
Summary
This a Phase 2a, multicenter, randomized, double-blind, placebo controlled 3 arm study to
assess the safety and tolerability of multiple oral doses of REL-1017 25 mg and 50 mg as
adjunctive therapy in the treatment of patients diagnosed with major depressive disorder
(MDD). The patients will be adults with MDD who are diagnosed with a current MDE who have
experienced an inadequate response to 1 to 3 courses of treatment with an antidepressant
medication. This population will provide the opportunity to compare the safety and efficacy
effects of treatment with an approved antidepressant in conjunction with REL-1017 versus the
effects of an antidepressant alone. This study includes in-patient and out-patient periods.