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NCT04103892 · ClinicalTrials.gov registry record · Phase 2
A Study of CLE-100 (Oral Esketamine) in Addition to Standard Antidepressant Drug for Major Depressive Disorder - CLEO Study
A Phase 2 study of Adjunctive Treatment of Major Depressive Disorder, sponsored by Clexio Biosciences.
- Completed
- Registry status
- Phase 2
- Development phase
- 146
- Enrollment target
- 20
- Study locations
NCT04103892: Completed Phase 2 study of Adjunctive Treatment of Major Depressive Disorder, sponsored by Clexio Biosciences.
NCT04103892 is a Phase 2 study of Adjunctive Treatment of Major Depressive Disorder that has completed, run by Clexio Biosciences. The registered enrollment target is 146 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (10% higher). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04103892, a Phase 2 study of Adjunctive Treatment of Major Depressive Disorder, has completed, sponsored by Clexio Biosciences.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 146 participants
- Enrollment target
- 20
- Study locations
Study Summary
The clinical trial is a Phase 2, double-blind, randomized, placebo controlled study in Major Depressive Disorder (MDD) participants currently treated with antidepressant therapy. The objective of the study is to assess CLE-100 for the treatment of MDD in participants currently treated with standard antidepressant therapy.
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.
Conditions Studied
Interventions
- DRUG placebo
- DRUG CLE-100
Study Locations (20)
California
- Clinical Site 141 - Anaheim
- Clinical Site 115 - Bellflower
- Clinical Site 132 - Lafayette
- Clinical Site 117 - Oakland
- Clinical Site 113 - Oceanside
- Clinical Site 123 - Riverside
- Clinical Site 124 - Santa Ana
- Clinical Site 142 - Santa Rosa
- Clinical Site 112 - Torrance
Florida
- Clinical Site 107 - Hialeah
- Clinical Site 116 - Miami
- Clinical Site 108 - Miami Gardens
- Clinical Site 105 - Orlando
- Clinical Site 137 - Orlando
Arkansas
- Clinical Site 126 - Bentonville
- Clinical Site 120 - Little Rock
- Clinical Site 129 - Little Rock
Georgia
- Clinical Site 140 - Atlanta
- Clinical Site 104 - Decatur
Colorado
- Clinical Site 145 - Denver
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 146 participants |
| Start Date | 2019-09-05 |
| Est. Completion | 2022-10-05 |
| Phase | Phase 2 |
What the finished NCT04103892 record still lists
NCT04103892 is an interventional study that assigns participants to a tested intervention. The registered 146 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (10% higher).
The record links to 1 condition, with Adjunctive Treatment of Major Depressive Disorder appearing as the primary indexed condition, and to 2 interventions - of which placebo is the first listed.
NCT04103892 names 20 study sites across 5 states, led by California, Florida, Arkansas.
Frequently Asked Questions
What is clinical trial NCT04103892 about?
NCT04103892 is a clinical study titled "A Study of CLE-100 (Oral Esketamine) in Addition to Standard Antidepressant Drug for Major Depressive Disorder - CLEO Study". The clinical trial is a Phase 2, double-blind, randomized, placebo controlled study in Major Depressive Disorder (MDD) participants currently treated with antidepressant therapy. The objective of the study is to assess CLE-100 for the treatment of MDD in participants currently treated with standard ...
What is the current status of trial NCT04103892?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 146 participants. The study started on 2019-09-05. Estimated completion is 2022-10-05.
What conditions does trial NCT04103892 study?
This clinical trial studies the following conditions: Adjunctive Treatment of Major Depressive Disorder.
What interventions are being tested in trial NCT04103892?
The interventions under investigation include: placebo (DRUG), CLE-100 (DRUG).
Who is sponsoring clinical trial NCT04103892?
This trial is sponsored by Clexio Biosciences, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04103892 being conducted?
This trial has 20 study locations across Arkansas, California, Colorado, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04103892's enrollment target sits among peer trials
146 496th of 2000 higher than 1,503 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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