A Study of CLE-100 (Oral Esketamine) as an Adjunctive Treatment to Standard Antidepressants for Major Depressive Disorder (SOLEO)
Double-blind, randomized, placebo-controlled Phase II outpatient trial (n=90) evaluating CLE-100 (oral esketamine) 1 tablet once daily adjunctive to standard antidepressant therapy for 4 weeks in adults with MDD and inadequate response to ≥2 antidepressants.
Details
SOLEO is a Phase II, double-blind, randomized, placebo-controlled, parallel-group study evaluating the efficacy, safety, and tolerability of oral esketamine (CLE-100) given once daily for 4 weeks as an adjunct to an ongoing oral antidepressant in adults with MDD who have had an inadequate response to at least two antidepressants.
Participants who complete the 4-week double-blind period and meet eligibility may roll over into a 6-month open-label extension with CLE-100. Assessments include MADRS, safety labs, vitals, C-SSRS, and other standard tolerability measures.