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

Completed · Phase 2 · Has a placebo group

Conditions studied: Adjunctive Treatment of Major Depressive Disorder (MDD)

In brief

The study is a Phase 2, double-blind, randomized, placebo-controlled study in Major Depressive Disorder (MDD) participants with an inadequate response to standard antidepressants The objective of the study is to assess CLE-100 (oral esketamine) for the treatment of MDD in participants currently treated with an oral antidepressant medication and who have an inadequate response to at least 2 antidepressants.

Key facts

Study ID

NCT06340958

Run by

Clexio Biosciences Ltd.

People needed

99

Starts

2024-03-18

Expected to finish

2025-11-25

Last updated by the study team

2026-06-23

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female between 18 to 65 years of age at Screening
• 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.
• 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.
• MADRS score of 24 or higher at Screening as confirmed by an independent SAFER assessor.
• 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.
• Able and competent to read and sign the informed consent form (ICF).

You may not qualify if…

• At Screening, a history of inadequate response (as defined in inclusion criterion #5) to more than 5 antidepressant medications in the current MDE using MGH-ATRQ and confirmed by the independent SAFER assessor.
• A high risk of suicide based on any of the following:
• Item 10 of MADRS score (suicidal thoughts) is 5 or higher at Screening or Baseline.
• Suicide attempt in the previous 6 months.
• Significant risk, as judged by the Investigator, based on the psychiatric interview or information collected with the C SSRS at Screening or Baseline.
• 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).
• Use of ketamine, esketamine, PCP, or dextromethorphan recreationally in the past 6 months.
• History or current diagnosis of bipolar disorder, schizophrenia, or schizoaffective disorder or other schizophrenia spectrum disorders.
• Dementia, delirium, amnesia, or any other significant cognitive disorder.
• 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).

Where it is running

• 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

Full record on ClinicalTrials.gov

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