NCT04103892

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

A Two-Part Study of CLE-100 as an Adjunct Therapy in Subjects With Major Depressive Disorder

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 146 (actual)
• Sponsor: Clexio Biosciences Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

CLEO study is performed in two parts (part A and Part B). Part A will be an inpatient study to assess the safety, tolerability, and pharmacokinetics of CLE-100 (oral esketamine) in MDD participants currently treated with an antidepressant drug. It will include a screening phase (up to 35 days), a 1 week inpatient double-blind treatment phase and an outpatient post treatment safety follow-up phase of 1 week after last study drug administration. Part B will be a study to assess the safety and efficacy of CLE-100 (oral esketamine) in MDD participants currently treated with an antidepressant drug with inadequate response to standard antidepressant therapy. The participants will remain on their current antidepressant therapy with no dose change during the study.

Conditions

• Adjunctive Treatment of Major Depressive Disorder

Interventions

Type	Name	Description
DRUG	CLE-100	1 tablet of CLE-100 administered once daily
DRUG	placebo	1 tablet of placebo administered once daily

Timeline

• Start date: 2019-09-05
• Primary completion: 2022-09-21
• Completion: 2022-10-05
• First posted: 2019-09-26
• Last updated: 2025-10-14
• Results posted: 2025-09-24

Locations

46 sites across 2 countries: United States, Puerto Rico

Regulatory

• FDA-regulated drug study