Adjunctive Treatment of Major Depressive Disorder Clinical Trial
Official title:
A Two-Part Study of CLE-100 as an Adjunct Therapy in Subjects With Major Depressive Disorder
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.
CLEO study is performed in two parts (part A and Part B). The sponsor is currently recruiting only for the Part B of the study. Part A will be an inpatient study to assess the safety, tolerability, and pharmacokinetics of CLE-100 (oral esketamine) 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. Part B will be a study to assess the safety and efficacy of CLE-100 (oral esketamine) in MDD participants currently treated with an antidepressant drug with inadequate response to standard antidepressant therapy. The participants will remain on their current antidepressant therapy with no dose change during the study. ;
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