A Study of CLE-100 (Oral Esketamine) as an Adjunctive Treatment to Standard Antidepressants for Major Depressive Disorder
Phase 2
Completed
NCT06340958
| Condition | Adjunctive Treatment of Major Depressive Disorder |
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| Phase | Phase 2 |
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| Sponsor | Clexio Biosciences Ltd. |
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| Status | Completed |
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| Enrollment | 99 participants |
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| Interventions | CLE-100 |
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| Start date | Mar 18, 2024 |
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| Completion date | Jun 6, 2025 |
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| Results posted | Jun 23, 2026 |
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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.
Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Score
29 days · units on a scale
| CLE-100 | -11.66 ± 1.50 units on a scale |
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| Placebo | -8.70 ± 1.55 units on a scale |
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| p-value | 0.15 |
| Least square (LS) mean difference | -2.96 (95% CI -7.01–1.09) |
Open in BENITIONS
View on ClinicalTrials.gov
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