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Esketamine for Major Depressive Disorder (SOLEO Trial)

Phase 2
Recruiting
Research Sponsored by Clexio Biosciences Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 7 months

Summary

This trial tests a new medication in people with major depression who haven't improved with at least two other treatments. The drug works by changing brain chemicals to improve mood quickly. It has been approved for adults with difficult-to-treat depression and has been tested in various forms.

Who is the study for?
This trial is for individuals with Major Depressive Disorder (MDD) who haven't had enough improvement from at least two standard antidepressants. Participants must be currently taking an oral antidepressant.
What is being tested?
The study tests CLE-100, a form of oral esketamine, as an add-on to existing antidepressant treatment versus a placebo. It's a Phase 2 trial where participants are randomly assigned to either the test drug or placebo without knowing which one they receive.
What are the potential side effects?
While specific side effects for CLE-100 aren't listed here, esketamine may cause dizziness, nausea, sedation, dissociation (feeling disconnected), increased blood pressure, and potential for abuse.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 7 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 7 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) score
Change from Baseline in the Clinical Global Impression - Severity (CGI-S)
Safety Outcomes: Assessment of the safety and tolerability of CLE-100 compared to placebo

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: CLE-100Experimental Treatment1 Intervention
1 oral tablet of CLE-100 once daily (in addition to current anti-depressant drug) for 4 weeks
Group II: PlaceboPlacebo Group1 Intervention
1 oral tablet of Placebo once daily (in addition to current anti-depressant drug) for 4 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CLE-100
2019
Completed Phase 2
~130

Find a Location

Who is running the clinical trial?

Clexio Biosciences Ltd.Lead Sponsor
2 Previous Clinical Trials
184 Total Patients Enrolled
~42 spots leftby Jul 2025
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