NCT06340958

A Study of CLE-100 (Oral Esketamine) as an Adjunctive Treatment to Standard Antidepressants for Major Depressive Disorder

A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel-Design, Phase 2 Study to Assess the Efficacy and Safety of CLE-100 as an Adjunctive Treatment for Major Depressive Disorder Patients With Inadequate Response to Standard Antidepressants

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 99 (actual)
• Sponsor: Clexio Biosciences Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The study is a Phase 2, double-blind, randomized, placebo-controlled study in Major Depressive Disorder (MDD) participants with an inadequate response to standard antidepressants The objective of the study is to assess CLE-100 (oral esketamine) for the treatment of MDD in participants currently treated with an oral antidepressant medication and who have an inadequate response to at least 2 antidepressants.

Detailed description

This is a Phase 2 study in subjects with MDD currently treated with an oral antidepressant medication with an inadequate response to at least 2 antidepressants. SOLEO will be an outpatient study to assess the safety, efficacy, and tolerability of CLE-100 as compared to placebo. Eligible subjects will be randomized to receive either placebo or CLE-100 (oral esketamine) once daily in addition to their current oral antidepressant monotherapy for 4 weeks. All subjects who adequately completed the 4-week Double-Blind Treatment Period and who meet the eligibility criteria will be offered the option to roll-over to a 6-month Open-label Extension (OLE) Treatment Period with CLE-100.

Conditions

• Adjunctive Treatment of Major Depressive Disorder (MDD)

Interventions

Type	Name	Description
DRUG	CLE-100	1 tablet of CLE-100 administered once daily
DRUG	Placebo	1 tablet of placebo administered once daily

Timeline

• Start date: 2024-03-18
• Primary completion: 2025-06-06
• Completion: 2025-11-25
• First posted: 2024-04-02
• Last updated: 2026-03-19

Locations

23 sites across 1 country: United States

Regulatory

• FDA-regulated drug study