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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.

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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.

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

FieldValue
Enrollment Target 146 participants
Start Date 2019-09-05
Est. Completion 2022-10-05
Phase Phase 2

Sponsor

Clexio Biosciences

3 total trials

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.