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CLE-100 for Antidepressants (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

Awards & highlights

SOLEO Trial Summary

This trial is testing a new medication called CLE-100 (oral esketamine) for treating Major Depressive Disorder (MDD) in people who have not responded well to standard antidepressants.

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.Check my eligibility

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.See study design

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.

SOLEO Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 7 months

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Secondary outcome measures

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

SOLEO 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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Clexio Biosciences Ltd.Lead Sponsor

2 Previous Clinical Trials

170 Total Patients Enrolled

Frequently Asked Questions

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

Which individuals meet the eligibility criteria for enrollment in this research study?

"Individuals aged between 18 and 65 years with a history of antidepressant use are eligible to participate in this study. The research team aims to recruit a total of 90 volunteers."

Answered by AI

At present, how many distinct locations are simultaneously conducting this experimental investigation?

"This study is actively ongoing at Clinical Site 105 in Lauderhill, Clinical Site 128 in Marlton, and Clinical Site 101 in Toms River, alongside an additional 4 undisclosed locations."

Answered by AI

What are the risks associated with CLE-100 in individuals?

"In our assessment at Power, the safety rating for CLE-100 is 2 on a scale of 1 to 3. This Phase 2 trial has existing data supporting its safety profile but lacks evidence regarding its effectiveness."

Answered by AI

Are patients currently being actively recruited for participation in this study?

"Affirmative. Records on clinicaltrials.gov confirm that recruitment for this trial is ongoing. The study was originally listed on March 18, 2024, and had its latest update recorded on April 1, 2024. In total, the research aims to enroll 90 participants distributed among four different sites."

Answered by AI