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CLE-100 as an Oral Therapy in Addition to Standard Antidepressant Drug for Major Depressive Disorder - CLEO Study

2019-10-01 07:55:13 | BioPortfolio

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.

Description

CLEO study is performed in two parts (part A and Part B). The sponsor is currently recruiting only for the Part A of the study.

Part A will be an inpatient study to assess the safety, tolerability, and pharmacokinetics of CLE-100 in MDD participants currently treated with an antidepressant drug. It will include a screening phase (up to 35 days), a 1 week inpatient double-blind treatment phase and an outpatient post treatment safety follow-up phase of 1 week after last study drug administration. The participants will remain on their current antidepressant therapy with no dose change during the study.

Study Design

Conditions

Adjunctive Treatment of Major Depressive Disorder

Intervention

CLE-100, placebo

Location

Hassman Research Institute, LLC
Marlton
New Jersey
United States
08053

Status

Recruiting

Source

Clexio Biosciences Ltd.

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-10-01T07:55:13-0400

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