At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel-Design, Phase 2 Study to Assess the Efficacy and Safety of CLE-100 as an Adjunctive Treatment for Major Depressive Disorder Patients With Inadequate Response to Standard Antidepressants
In Brief
A Phase 2 clinical trial evaluating CLE-100 and Placebo for Adjunctive Treatment of Major Depressive Disorder (MDD). Completed, enrolled 99 participants across 23 sites.
Signals
Detailed Summary
The study is a Phase 2, double-blind, randomized, placebo-controlled study in Major Depressive Disorder (MDD) participants with an inadequate response to standard antidepressants The objective of the study is to assess CLE-100 (oral esketamine) for the treatment of MDD in participants currently treated with an oral antidepressant medication and who have an inadequate response to at least 2 antidepressants.
Study Details
Timeline
Arms & Interventions
1 oral tablet of CLE-100 once daily (in addition to current anti-depressant drug) for 4 weeks
1 oral tablet of Placebo once daily (in addition to current anti-depressant drug) for 4 weeks.
Interventions
1 tablet of CLE-100 administered once daily
1 tablet of placebo administered once daily