drugset / Trial / NCT06340958
A Study of CLE-100 (Oral Esketamine) as an Adjunctive Treatment to Standard Antidepressants for Major Depressive Disorder
RandomizedParallel-groupDouble-blindTreatment
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.
Timeline
- Start
- 2024-03-18
- Primary completion
- 2025-06-06
- Completion
- 2025-11-25
Outcome
Missed primary endpoint
registry analysis (superiority test); CLE-100 vs Placebo; p = 0.15; Least square (LS) mean difference -2.96 (95% CI -7.01 to 1.09); Mixed Models Repeated Measures (MMRM) NCT06340958 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | CLE-100 | Unknown | — | Oral |
Indications
No indication recorded.