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

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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

NCT04103892•Clexio Biosciences Ltd.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Male or female between 18 to 60 years of age
•2. Primary diagnosis of MDD, without psychotic features according to DSM-5 and supported by the Mini International Neuropsychiatric Interview (MINI)
•3. MADRS score of at least 18 at Screening
•4. Treatment with stable dose of the current antidepressant therapy for at least 4 weeks for the current major depressive episode (MDE)
•5. Body mass index (BMI) between 18 and 40 kg/m2, inclusive
•6. Is able and competent to read and sign the informed consent form (ICF).
•1. Male or female between 18 to 65 years of age
•2. Primary diagnosis of MDD without psychotic features according to DSM-5 and supported by the Mini International Neuropsychiatric Interview (MINI)
•3. MADRS score of at least 24 at Screening.
•4. At least 2 inadequate responses to antidepressant therapy (ADT) in the current Major Depressive Episode (MDE)
+3 more criteria

Exclusion Criteria

•1. History of substance use disorder per DSM-5 criteria, except for tobacco use disorder
•2. History or current diagnosis of bipolar disorder, schizophrenia, schizoaffective disorders, binge eating disorder dementia, delirium, amnesia, or any other significant cognitive disorder
•3. Posttraumatic stress disorder, obsessive compulsive disorder, or any other mental disorder (including personality disorders)
•4. Has any medical condition for which an increase in blood pressure or intracranial pressure poses a serious risk
•5. Female of childbearing potential without appropriate contraceptive means, pregnant or breastfeeding
•1. Inadequate response to more than 5 treatment courses of antidepressant medication therapy during the current MDE
•2. Current MDE for longer than 5 years.
•3. 3\. Has a current substance use disorder or history of any substance use disorder per DSM-5 criteria within 12 months prior to Screening, except for tobacco use disorder.
•4. Has a history or current diagnosis of bipolar disorder, schizophrenia, or schizoaffective disorders.
•5. Has dementia, delirium, amnesia, or any other significant cognitive disorder.
+4 more criteria

Locations (46)

Clinical Site 126

Bentonville, Arkansas, United States

Clinical Site 120

Little Rock, Arkansas, United States

Clinical Site 129

Little Rock, Arkansas, United States

Clinical Site 141

Anaheim, California, United States

Clinical Site 115

Bellflower, California, United States

Clinical Site 132

Lafayette, California, United States

Clinical Site 117

Oakland, California, United States

Clinical Site 113

Oceanside, California, United States

Clinical Site 123

Riverside, California, United States

Clinical Site 124

Santa Ana, California, United States

Key Dates

Start Date

September 5, 2019

Primary Completion Date

September 21, 2022

Completion Date

October 5, 2022

Last Updated

October 14, 2025

Enrollment

146

ACTUAL participants

Conditions

Adjunctive Treatment of Major Depressive Disorder

Interventions

CLE-100

DRUG

placebo

DRUG

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

NCT06340958

Adjunctive Treatment of Major Depressive Disorder (MDD)

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 14, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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