BENITIONSClinical Trial Intelligence

A Study of CLE-100 (Oral Esketamine) as an Adjunctive Treatment to Standard Antidepressants for Major Depressive Disorder

Phase 2 Completed NCT06340958

ConditionAdjunctive Treatment of Major Depressive Disorder
PhasePhase 2
SponsorClexio Biosciences Ltd.
StatusCompleted
Enrollment99 participants
InterventionsCLE-100
Start dateMar 18, 2024
Completion dateJun 6, 2025
Results postedJun 23, 2026

Summary

The study is a Phase 2, 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.

Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Score

29 days · units on a scale

CLE-100-11.66 ± 1.50 units on a scale
Placebo-8.70 ± 1.55 units on a scale
p-value0.15
Least square (LS) mean difference-2.96 (95% CI -7.01–1.09)

Open in BENITIONS View on ClinicalTrials.gov

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