A Study of CLE-100 (Oral Esketamine) as an Adjunctive Treatment to Standard Antidepressants for Major Depressive Disorder
SOLEO
A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel-Design, Phase 2 Study to Assess the Efficacy and Safety of CLE-100 as an Adjunctive Treatment for Major Depressive Disorder Patients With Inadequate Response to Standard Antidepressants
1 other identifier
interventional
99
1 country
23
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Mar 2024
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 18, 2024
CompletedFirst Submitted
Initial submission to the registry
March 25, 2024
CompletedFirst Posted
Study publicly available on registry
April 2, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 6, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
November 25, 2025
CompletedMarch 19, 2026
September 1, 2025
1.2 years
March 25, 2024
March 17, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (3)
Change from Baseline in the Clinical Global Impression - Severity (CGI-S)
29 days
Change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) score
2 weeks
Safety Outcomes: Assessment of the safety and tolerability of CLE-100 compared to placebo
Through study completion, an average of 7 months
Study Arms (2)
CLE-100
EXPERIMENTAL1 oral tablet of CLE-100 once daily (in addition to current anti-depressant drug) for 4 weeks
Placebo
PLACEBO COMPARATOR1 oral tablet of Placebo once daily (in addition to current anti-depressant drug) for 4 weeks.
Interventions
Eligibility Criteria
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:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (23)
Clinical Site 139
La Jolla, California, 92037, United States
Clinical Site 131
Lafayette, California, 94549, United States
Clinical Site 130
Upland, California, 91786, United States
Clinical Site 102
Hollywood, Florida, 33024, United States
Clinical Site 105
Lauderhill, Florida, 33319, United States
Clinical Site 140
Miami Springs, Florida, 33166, United States
Clinical Site 132
Pensacola, Florida, 32502, United States
Clinical Site 118
Atlanta, Georgia, 30030, United States
Clinical Site 138
Marietta, Georgia, 30060, United States
Clinical Site 114
Savannah, Georgia, 31405, United States
Clinical Site 127
Chicago, Illinois, 60640, United States
Clinical Site 120
Elgin, Illinois, 60123, United States
Clinical Site 108
Gaithersburg, Maryland, 20877, United States
Clinical Site 116
Flowood, Mississippi, 39232, United States
Clinical Site 126
O'Fallon, Missouri, 63368, United States
Clinical Site 101
Toms River, New Jersey, 08755, United States
Clinical Site 103
Beachwood, Ohio, 44236, United States
Clinical Site 119
North Canton, Ohio, 44720, United States
Clinical Site 135
Oklahoma City, Oklahoma, 73112, United States
Clinical Site 107
Austin, Texas, 78737, United States
Clinical Site 137
Plano, Texas, 75093, United States
Clinical Site 117
Murray, Utah, 84107, United States
Clinical Site 115
Bellevue, Washington, 98007, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
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
Study Record Dates
First Submitted
March 25, 2024
First Posted
April 2, 2024
Study Start
March 18, 2024
Primary Completion
June 6, 2025
Study Completion
November 25, 2025
Last Updated
March 19, 2026
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share