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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

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

Treatment of Major Depressive Disorder

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 29 days

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

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Who is running the clinical trial?

Clexio Biosciences Ltd.Lead Sponsor

2 Previous Clinical Trials

144 Total Patients Enrolled

~22 spots leftby Sep 2025

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