A Study of CLE-100 (Oral Esketamine) as an Adjunctive Treatment to Standard Antidepressants for Major Depressive Disorder
NCT ID: NCT06340958
Last Updated: 2025-09-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
90 participants
INTERVENTIONAL
2024-03-18
2026-01-10
Brief Summary
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Detailed Description
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Eligible subjects will be randomized to receive either placebo or CLE-100 (oral esketamine) once daily in addition to their current oral antidepressant monotherapy for 4 weeks. All subjects who adequately completed the 4-week Double-Blind Treatment Period and who meet the eligibility criteria will be offered the option to roll-over to a 6-month Open-label Extension (OLE) Treatment Period with CLE-100.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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CLE-100
1 oral tablet of CLE-100 once daily (in addition to current anti-depressant drug) for 4 weeks
CLE-100
1 tablet of CLE-100 administered once daily
Placebo
1 oral tablet of Placebo once daily (in addition to current anti-depressant drug) 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. Diagnosis of MDD, single or recurrent, without psychotic features, in the current or previous episode(s), according to the Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5). The diagnosis of MDD must be supported by the Mini International Neuropsychiatric Interview (MINI) Screen 7.0.2 for DSM-5.
3. Currently experiencing a Major Depressive Episode (MDE) that began at least 12 weeks but no more than 5 years prior to Screening. The current MDE must be confirmed by the independent SAFER assessor.
4. MADRS score of 24 or higher at Screening as confirmed by an independent SAFER assessor.
5. At Screening, a history of inadequate response to at least 2 antidepressant medications in the current MDE. Inadequate response is defined as less than 50% improvement of depression symptoms following at least 6 weeks of treatment with a therapeutic dose and is assessed by the site using the Massachusetts General Hospital Antidepressant Treatment Response Questionnaire (MGH-ATRQ). Inadequate response to at least 2 antidepressant medications must be verified by documented medical or pharmacy records and confirmed by an independent SAFER assessor.
6. Able and competent to read and sign the informed consent form (ICF).
Exclusion Criteria
2. A high risk of suicide based on any of the following:
1. Item 10 of MADRS score (suicidal thoughts) is 5 or higher at Screening or Baseline.
2. Suicide attempt in the previous 6 months.
3. Significant risk, as judged by the Investigator, based on the psychiatric interview or information collected with the C SSRS at Screening or Baseline.
3. Current or lifetime history of substance use disorder with ketamine, phencyclidine (PCP), lysergic acid diethylamide (LSD), or 3.4-methylenedioxymethamphetamine (MDMA) hallucinogen-related use disorders or has any other current substance use disorder or history within 12 months prior to Screening (Substance Use Disorder is diagnosed per DSM-5 criteria and does not include tobacco use disorder).
4. Use of ketamine, esketamine, PCP, or dextromethorphan recreationally in the past 6 months.
5. History or current diagnosis of bipolar disorder, schizophrenia, or schizoaffective disorder or other schizophrenia spectrum disorders.
6. Dementia, delirium, amnesia, or any other significant cognitive disorder.
7. Any medical condition for which an increase in blood pressure or intracranial pressure or intraocular pressure or tachycardia poses a serious risk (e.g., aneurysmal vascular disease, arteriovenous malformation, or history of intracerebral hemorrhage).
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 139
La Jolla, California, United States
Clinical Site 131
Lafayette, California, United States
Clinical Site 130
Upland, California, United States
Clinical Site 102
Hollywood, Florida, United States
Clinical Site 105
Lauderhill, Florida, United States
Clinical Site 140
Miami Springs, Florida, United States
Clinical Site 132
Pensacola, Florida, United States
Clinical Site 118
Atlanta, Georgia, United States
Clinical Site 138
Marietta, Georgia, United States
Clinical Site 114
Savannah, Georgia, United States
Clinical Site 127
Chicago, Illinois, United States
Clinical Site 120
Elgin, Illinois, United States
Clinical Site 108
Gaithersburg, Maryland, United States
Clinical Site 116
Flowood, Mississippi, United States
Clinical Site 126
O'Fallon, Missouri, United States
Clinical Site 101
Toms River, New Jersey, United States
Clinical Site 103
Beachwood, Ohio, United States
Clinical Site 119
North Canton, Ohio, United States
Clinical Site 135
Oklahoma City, Oklahoma, United States
Clinical Site 107
Austin, Texas, United States
Clinical Site 137
Plano, Texas, United States
Clinical Site 117
Murray, Utah, United States
Clinical Site 115
Bellevue, Washington, United States
Countries
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Other Identifiers
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CLE100-MDD-202
Identifier Type: -
Identifier Source: org_study_id
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