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

NCT04103892 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 146

Last updated 2025-10-14

Study results available
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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.

Conditions

  • Adjunctive Treatment of Major Depressive Disorder

Interventions

DRUG

CLE-100

1 tablet of CLE-100 administered once daily

DRUG

placebo

1 tablet of placebo administered once daily

Sponsors & Collaborators

  • Clexio Biosciences Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-05
Primary Completion
2022-09-21
Completion
2022-10-05
FDA Drug
Yes

Countries

  • United States
  • Puerto Rico

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04103892 on ClinicalTrials.gov