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NCT06340958 · ClinicalTrials.gov registry record · Phase 2
A Study of CLE-100 (Oral Esketamine) as an Adjunctive Treatment to Standard Antidepressants for Major Depressive Disorder
A Phase 2 study, sponsored by Clexio Biosciences.
- Completed
- Registry status
- Phase 2
- Development phase
- 99
- Enrollment target
NCT06340958: Completed Phase 2 study, sponsored by Clexio Biosciences.
NCT06340958 is a Phase 2 study that has completed, run by Clexio Biosciences. The registered enrollment target is 99 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (26% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06340958, a Phase 2 study, has completed, sponsored by Clexio Biosciences.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 99 participants
- Enrollment target
Study 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.
Primary Outcome
The MADRS is a validated clinician-administered measurement of depression severity commonly used in clinical trials of depression treatments to select subjects and assess efficacy. The test consists of 10 items, each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total possible score of 60. Higher scores represent a more severe condition.
Interventions
- DRUG Placebo
- DRUG CLE-100
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 99 participants |
| Start Date | 2024-03-18 |
| Est. Completion | 2025-11-25 |
| Phase | Phase 2 |
What the finished NCT06340958 record still lists
NCT06340958 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 99 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (26% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT06340958 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06340958 about?
NCT06340958 is a clinical study titled "A Study of CLE-100 (Oral Esketamine) as an Adjunctive Treatment to Standard Antidepressants for Major Depressive Disorder". 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 trea...
What is the current status of trial NCT06340958?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 99 participants. The study started on 2024-03-18. Estimated completion is 2025-11-25.
What interventions are being tested in trial NCT06340958?
The interventions under investigation include: Placebo (DRUG), CLE-100 (DRUG).
Who is sponsoring clinical trial NCT06340958?
This trial is sponsored by Clexio Biosciences, which has 3 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06340958's enrollment target sits among peer trials
99 738th of 2000 higher than 1,258 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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