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CLE-100 for Treatment of Major Depressive Disorder

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
Awards & highlights

Study Summary

This trial will test whether the study drug CLE-100 is effective in treating Major Depressive Disorder in patients who are already taking antidepressant medication. The trial is double-blind, meaning neither the patients nor the doctors will know who is receiving the study drug and who is receiving the placebo. The trial is also randomized, meaning that patients will be assigned to either the study drug or the placebo group by chance.

Eligible Conditions
  • Treatment of Major Depressive Disorder

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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
+9 more
Secondary outcome measures
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
130 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?
California
New York
How old are they?
18 - 65
What site did they apply to?
Clinical Site 128
Clinical Site 132
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
A Study of CLE-100 (Oral Esketamine) in Addition to Standard Antidepressant Drug for Major Depressive Disorder - CLEO Study
2019. "A Study of CLE-100 (Oral Esketamine) in Addition to Standard Antidepressant Drug for Major Depressive Disorder - CLEO Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04103892.
~23 spots leftby Apr 2025
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