This double-blind, randomized, placebo-controlled, multicenter, parallel-design Phase II trial (n=90) aims to assess the efficacy and safety of CLE-100 (oral esketamine) as an adjunctive treatment for Major Depressive Disorder (MDD) patients who have shown an inadequate response to standard antidepressants.
CLE-100, an oral esketamine, will be administered once daily alongside the current oral antidepressant medication for 4 weeks. Participants who complete the 4-week treatment period satisfactorily will have the option to continue into a 6-month open-label extension period with CLE-100.
The primary outcome measure will be the change from baseline in Montgomery-Asberg Depression Rating Scale (MADRS) score after 29 days. Secondary outcome measures include changes in Clinical Global Impression – Severity (CGI-S) score, MADRS score after 2 weeks, and various safety assessments.
The study began in March 2024 and is expected to conclude in January 2026. Recruitment is ongoing across multiple locations in the United States, including Florida, Georgia, Maryland, New Jersey, Utah, and Washington.
Trial Details
The study is a Phase II, double-blind, randomized, placebo-controlled study in Major Depressive Disorder (MDD) participants with an inadequate response to standard antidepressants The objective of the study is to assess CLE-100 (oral esketamine) for the treatment of MDD in participants currently treated with an oral antidepressant medication and who have an inadequate response to at least 2 antidepressants.NCT Number NCT06340958