A Study of CLE-100 (Oral Esketamine) as an Adjunctive Treatment to Standard Antidepressants for Major Depressive Disorder
Public ClinicalTrials.gov record NCT06340958. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT06340958
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 99 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 18 Years to 65 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 18, 2024 (Actual)
- Primary completion
- Jun 6, 2025 (Actual)
- Completion
- Nov 25, 2025 (Actual)
- Last update posted
- Jun 23, 2026
2024 – 2025
United States locations
- U.S. sites
- 23
- U.S. states
- 13
- U.S. cities
- 23
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Clinical Site 139 | La Jolla | California | 92037 | — |
| Clinical Site 131 | Lafayette | California | 94549 | — |
| Clinical Site 130 | Upland | California | 91786 | — |
| Clinical Site 102 | Hollywood | Florida | 33024 | — |
| Clinical Site 105 | Lauderhill | Florida | 33319 | — |
| Clinical Site 140 | Miami Springs | Florida | 33166 | — |
| Clinical Site 132 | Pensacola | Florida | 32502 | — |
| Clinical Site 118 | Atlanta | Georgia | 30030 | — |
| Clinical Site 138 | Marietta | Georgia | 30060 | — |
| Clinical Site 114 | Savannah | Georgia | 31405 | — |
| Clinical Site 127 | Chicago | Illinois | 60640 | — |
| Clinical Site 120 | Elgin | Illinois | 60123 | — |
| Clinical Site 108 | Gaithersburg | Maryland | 20877 | — |
| Clinical Site 116 | Flowood | Mississippi | 39232 | — |
| Clinical Site 126 | O'Fallon | Missouri | 63368 | — |
| Clinical Site 101 | Toms River | New Jersey | 08755 | — |
| Clinical Site 103 | Beachwood | Ohio | 44236 | — |
| Clinical Site 119 | North Canton | Ohio | 44720 | — |
| Clinical Site 135 | Oklahoma City | Oklahoma | 73112 | — |
| Clinical Site 107 | Austin | Texas | 78737 | — |
| Clinical Site 137 | Plano | Texas | 75093 | — |
| Clinical Site 117 | Murray | Utah | 84107 | — |
| Clinical Site 115 | Bellevue | Washington | 98007 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06340958, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 23, 2026 · Synced Oct 17, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT06340958 live on ClinicalTrials.gov.