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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 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. The trial reports 20 study locations across 5 states.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04103892
The ClinicalTrials.gov registry entry for NCT04103892 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 146 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Clexio Biosciences, which has 3 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 5 distinct geographic areas - top geographies include 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.
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