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drugset / Trial / NCT04103892

A Study of CLE-100 (Oral Esketamine) in Addition to Standard Antidepressant Drug for Major Depressive Disorder - CLEO Study

NCT04103892 ↗

Phase 2 Completed 146 enrolled Clexio Biosciences Ltd.
RandomizedParallel-groupDouble-blindTreatment

Summary

The clinical trial is a Phase 2, double-blind, randomized, placebo controlled study in Major Depressive Disorder (MDD) participants currently treated with antidepressant therapy. The objective of the study is to assess CLE-100 for the treatment of MDD in participants currently treated with standard antidepressant therapy.

Timeline

Start
2019-09-05
Primary completion
2022-09-21
Completion
2022-10-05

Outcome

Missed primary endpoint

registry p = 0.46; Least square (LS) mean difference -1.26 (95% CI -4.60 to 2.09); NCT04103892 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject CLE-100 Unknown — Oral

Indications

No indication recorded.