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

NCT04103892 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: CLE100-MDD-201
• Study Type: interventional
• Target: 146
• Locations: 2 countries
• Sites: 46

Brief 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

Keywords

MDD; depression; depressive disorder; major depression; adjunct therapy; oral; esketamine

Outcome Measures

Primary Outcomes (1)

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

  The MADRS is a validated clinician-administered measurement of depression severity commonly used in clinical trials of depression treatments to select subjects and assess efficacy. The test consists of 10 items, each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total possible score of 60. Higher scores represent a more severe condition.

  29 days

Study Arms (4)

Part A - CLE-100 (oral esketamine)

EXPERIMENTAL

Part A: 1 oral tablet of CLE-100 once daily for 1 week.

Drug: CLE-100

Part A - Placebo

PLACEBO COMPARATOR

Part A: 1 oral tablet of Placebo once daily for 1 week.

Drug: placebo

Part B - CLE-100 (oral esketamine)

EXPERIMENTAL

Part B: 1 oral tablet of CLE-100 once daily for 4 weeks.

Drug: CLE-100

Part B - Placebo

PLACEBO COMPARATOR

Part B: 1 oral tablet of Placebo once daily for 4 weeks.

Drug: placebo

Interventions

CLE-100 DRUG

1 tablet of CLE-100 administered once daily

Part A - CLE-100 (oral esketamine); Part B - CLE-100 (oral esketamine)

placebo DRUG

1 tablet of placebo administered once daily

Part A - Placebo; Part B - Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• History of substance use disorder per DSM-5 criteria, except for tobacco use disorder
• History or current diagnosis of bipolar disorder, schizophrenia, schizoaffective disorders, binge eating disorder dementia, delirium, amnesia, or any other significant cognitive disorder
• Posttraumatic stress disorder, obsessive compulsive disorder, or any other mental disorder (including personality disorders)
• Has any medical condition for which an increase in blood pressure or intracranial pressure poses a serious risk
• Female of childbearing potential without appropriate contraceptive means, pregnant or breastfeeding
• Male or female between 18 to 65 years of age
• Primary diagnosis of MDD without psychotic features according to DSM-5 and supported by the Mini International Neuropsychiatric Interview (MINI)
• MADRS score of at least 24 at Screening.
• At least 2 inadequate responses to antidepressant therapy (ADT) in the current Major Depressive Episode (MDE)
• Current MDE for at least 12 weeks
• BMI between 18 and 40 kg/m2, inclusive.
• Is able and competent to read and sign the ICF.
• Inadequate response to more than 5 treatment courses of antidepressant medication therapy during the current MDE
• Current MDE for longer than 5 years.
• \. 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.

Sponsors & Collaborators

• Clexio Biosciences Ltd.: lead

Study Sites (46)

Clinical Site 126

Bentonville, Arkansas, 72712, United States

Location

Clinical Site 120

Little Rock, Arkansas, 72209, United States

Location

Clinical Site 129

Little Rock, Arkansas, 72209, United States

Location

Clinical Site 141

Anaheim, California, 92805, United States

Location

Clinical Site 115

Bellflower, California, 90706, United States

Location

Clinical Site 132

Lafayette, California, 94549, United States

Location

Clinical Site 117

Oakland, California, 94607, United States

Location

Clinical Site 113

Oceanside, California, 92056, United States

Location

Clinical Site 123

Riverside, California, 92506, United States

Location

Clinical Site 124

Santa Ana, California, 92705, United States

Location

Clinical Site 142

Santa Rosa, California, 95401, United States

Location

Clinical Site 112

Torrance, California, 90502, United States

Location

Clinical Site 145

Denver, Colorado, 80209, United States

Location

Clinical Site 107

Hialeah, Florida, 33016, United States

Location

Clinical Site 116

Miami, Florida, 33145, United States

Location

Clinical Site 108

Miami Gardens, Florida, 33014, United States

Location

Clinical Site 105

Orlando, Florida, 32803, United States

Location

Clinical Site 137

Orlando, Florida, 32807, United States

Location

Clinical Site 140

Atlanta, Georgia, 30338, United States

Location

Clinical Site 104

Decatur, Georgia, 30030, United States

Location

Clinical Site 122

Marietta, Georgia, 30060, United States

Location

Clinical Site 131

Baltimore, Maryland, 21208, United States

Location

Clinical Site 136

Rockville, Maryland, 20877, United States

Location

Clinical Site 103

Boston, Massachusetts, 02114, United States

Location

Clinical Site 121

Boston, Massachusetts, 02131, United States

Location

Clinical Site 151

Dearborn Heights, Michigan, 48034, United States

Location

Clinical Site 139

St Louis, Missouri, 63128, United States

Location

Clinical Site 125

Lincoln, Nebraska, 68526, United States

Location

Clinical Site 110

Las Vegas, Nevada, 89102, United States

Location

Clinical Site 101

Marlton, New Jersey, 08053, United States

Location

Clinical Site 148

Toms River, New Jersey, 08755, United States

Location

Clinical Site 128

New York, New York, 10036, United States

Location

Clinical Site 102

Staten Island, New York, 10312, United States

Location

Clinical Site 111

Hickory, North Carolina, 28601, United States

Location

Clinical Site 143

Raleigh, North Carolina, 27609, United States

Location

Clinical Site 138

Middleburg Heights, Ohio, 44130, United States

Location

Clinical Site 127

North Canton, Ohio, 44720, United States

Location

Clinical Site 106

Media, Pennsylvania, 19063, United States

Location

Clinical Site 118

Philadelphia, Pennsylvania, 19104, United States

Location

Clinical Site 114

Fort Worth, Texas, 76104, United States

Location

Clinical Site 109

Houston, Texas, 77030, United States

Location

Clinical Site 149

Missouri City, Texas, 88459, United States

Location

Clinical Site 144

Plano, Texas, 75093, United States

Location

Clinical Site 147

Draper, Utah, 84020, United States

Location

Clinical Site 135

Bellevue, Washington, 98007, United States

Location

Clinical Site 150

San Juan, 00918, Puerto Rico

Location

MeSH Terms

Conditions

Depression; Depressive Disorder; Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mood Disorders; Mental Disorders

Results Point of Contact

• Title: Regulatory Affairs Lead
• Organization: Clexio Biosciences Ltd

myriam.belahcen@clexio.com

972-733318704

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Part A - 16 patients, 2 arms, parallel; Part B - 130 patients, 2 arms, parallel

Study Record Dates

• First Submitted: September 9, 2019
• First Posted: September 26, 2019
• Study Start: September 5, 2019
• Primary Completion: September 21, 2022
• Study Completion: October 5, 2022
• Last Updated: October 14, 2025
• Results First Posted: September 24, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

PR (1); US (45)