A Study of CLE-100 (Oral Esketamine) in Addition to Standard Antidepressant Drug for Major Depressive Disorder - CLEO Study
NCT ID: NCT04103892
Last Updated: 2025-10-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
146 participants
INTERVENTIONAL
2019-09-05
2022-10-05
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Part A - CLE-100 (oral esketamine)
Part A: 1 oral tablet of CLE-100 once daily for 1 week.
CLE-100
1 tablet of CLE-100 administered once daily
Part A - Placebo
Part A: 1 oral tablet of Placebo once daily for 1 week.
placebo
1 tablet of placebo administered once daily
Part B - CLE-100 (oral esketamine)
Part B: 1 oral tablet of CLE-100 once daily for 4 weeks.
CLE-100
1 tablet of CLE-100 administered once daily
Part B - Placebo
Part B: 1 oral tablet of Placebo once daily for 4 weeks.
placebo
1 tablet of placebo administered once daily
Interventions
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CLE-100
1 tablet of CLE-100 administered once daily
placebo
1 tablet of placebo administered once daily
Eligibility Criteria
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Inclusion Criteria
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)
5. Current MDE for at least 12 weeks
6. BMI between 18 and 40 kg/m2, inclusive.
7. Is able and competent to read and sign the ICF.
Exclusion Criteria
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.
6. Has posttraumatic stress disorder, obsessive compulsive disorder, or any other mental disorder (including personality disorders, eating disorders, etc.).
7. Has any medical condition for which an increase in blood pressure or intracranial pressure poses a serious risk.
8. Has been randomized in Part A of this study.
9. Is a female of childbearing potential pregnant or breastfeeding.
18 Years
65 Years
ALL
No
Sponsors
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Clexio Biosciences Ltd.
INDUSTRY
Responsible Party
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Locations
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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
Clinical Site 142
Santa Rosa, California, United States
Clinical Site 112
Torrance, California, United States
Clinical Site 145
Denver, Colorado, United States
Clinical Site 107
Hialeah, Florida, United States
Clinical Site 116
Miami, Florida, United States
Clinical Site 108
Miami Gardens, Florida, United States
Clinical Site 105
Orlando, Florida, United States
Clinical Site 137
Orlando, Florida, United States
Clinical Site 140
Atlanta, Georgia, United States
Clinical Site 104
Decatur, Georgia, United States
Clinical Site 122
Marietta, Georgia, United States
Clinical Site 131
Baltimore, Maryland, United States
Clinical Site 136
Rockville, Maryland, United States
Clinical Site 103
Boston, Massachusetts, United States
Clinical Site 121
Boston, Massachusetts, United States
Clinical Site 151
Dearborn Heights, Michigan, United States
Clinical Site 139
St Louis, Missouri, United States
Clinical Site 125
Lincoln, Nebraska, United States
Clinical Site 110
Las Vegas, Nevada, United States
Clinical Site 101
Marlton, New Jersey, United States
Clinical Site 148
Toms River, New Jersey, United States
Clinical Site 128
New York, New York, United States
Clinical Site 102
Staten Island, New York, United States
Clinical Site 111
Hickory, North Carolina, United States
Clinical Site 143
Raleigh, North Carolina, United States
Clinical Site 138
Middleburg Heights, Ohio, United States
Clinical Site 127
North Canton, Ohio, United States
Clinical Site 106
Media, Pennsylvania, United States
Clinical Site 118
Philadelphia, Pennsylvania, United States
Clinical Site 114
Fort Worth, Texas, United States
Clinical Site 109
Houston, Texas, United States
Clinical Site 149
Missouri City, Texas, United States
Clinical Site 144
Plano, Texas, United States
Clinical Site 147
Draper, Utah, United States
Clinical Site 135
Bellevue, Washington, United States
Clinical Site 150
San Juan, , Puerto Rico
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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CLE100-MDD-201
Identifier Type: -
Identifier Source: org_study_id
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