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A Study of CLE-100 (Oral Esketamine) in Addition to Standard Antidepressant Drug for Major Depressive Disorder - CLEO Study

Phase 2
Waitlist Available
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 29 days

Summary

This trial is testing a new oral medication called esketamine for people with major depression who haven't improved with their current antidepressants. Esketamine works by balancing brain chemicals to help improve mood. The study aims to see if this new treatment is safe and effective. Esketamine is an antidepressant recently approved for treatment-resistant depression, with a novel mechanism of action.

Eligible Conditions
  • Antidepressants

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~29 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 29 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Part A - 20-item Physician Withdrawal Checklist (PWC-20)
Part A - Clinician-Administered Dissociative Symptoms Scale (CADSS)
Part A - Cognitive function evaluated by Cogstate battery
+8 more
Secondary study objectives
Part B - Change from baseline in Clinical Global Impression - Severity (CGI-S) score
Part B - Change from baseline in Montgomery-Asberg Depression Rating Scale (MADRS) score
Part B - Change from baseline in Sheehan Disability Scale (SDS)
+1 more

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: Part B - CLE-100 (oral esketamine)Experimental Treatment1 Intervention
Part B: 1 oral tablet of CLE-100 once daily for 4 weeks.
Group II: Part A - CLE-100 (oral esketamine)Experimental Treatment1 Intervention
Part A: 1 oral tablet of CLE-100 once daily for 1 week.
Group III: Part B - PlaceboPlacebo Group1 Intervention
Part B: 1 oral tablet of Placebo once daily for 4 weeks.
Group IV: Part A - PlaceboPlacebo Group1 Intervention
Part A: 1 oral tablet of Placebo once daily for 1 week.
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
144 Total Patients Enrolled
~21 spots leftby Dec 2025
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