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New oral esketamine pill shows promise for stubborn depression

NCT ID NCT06340958

Symptom relief Sponsor: Clexio Biosciences Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested an experimental drug called CLE-100 (oral esketamine) in 99 adults with major depression that didn't get better after trying at least two standard antidepressants. Participants took CLE-100 or a placebo pill alongside their usual antidepressant for several weeks. The goal was to see if adding CLE-100 could further reduce depression symptoms, measured by a standard rating scale.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

99 people

The number who actually took part.

Started

Mar 2024

Finished

Nov 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Male or female between 18 to 65 years of age at Screening 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: 1. 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. 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).

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Conditions

The condition(s) this trial relates to.

Depression depressive disorder major depressive disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Adjunctive treatment of major depressive disorder (MDD)

Contacts and locations

Locations

  • Clinical Site 101

    Toms River, New Jersey, 08755, United States

  • Clinical Site 102

    Hollywood, Florida, 33024, United States

  • Clinical Site 103

    Beachwood, Ohio, 44236, United States

  • Clinical Site 105

    Lauderhill, Florida, 33319, United States

  • Clinical Site 107

    Austin, Texas, 78737, United States

  • Clinical Site 108

    Gaithersburg, Maryland, 20877, United States

  • Clinical Site 114

    Savannah, Georgia, 31405, United States

  • Clinical Site 115

    Bellevue, Washington, 98007, United States

  • Clinical Site 116

    Flowood, Mississippi, 39232, United States

  • Clinical Site 117

    Murray, Utah, 84107, United States

  • Clinical Site 118

    Atlanta, Georgia, 30030, United States

  • Clinical Site 119

    North Canton, Ohio, 44720, United States

  • Clinical Site 120

    Elgin, Illinois, 60123, United States

  • Clinical Site 126

    O'Fallon, Missouri, 63368, United States

  • Clinical Site 127

    Chicago, Illinois, 60640, United States

  • Clinical Site 130

    Upland, California, 91786, United States

  • Clinical Site 131

    Lafayette, California, 94549, United States

  • Clinical Site 132

    Pensacola, Florida, 32502, United States

  • Clinical Site 135

    Oklahoma City, Oklahoma, 73112, United States

  • Clinical Site 137

    Plano, Texas, 75093, United States

  • Clinical Site 138

    Marietta, Georgia, 30060, United States

  • Clinical Site 139

    La Jolla, California, 92037, United States

  • Clinical Site 140

    Miami Springs, Florida, 33166, United States