At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 146 enrolled
Drug / intervention
CLE-100 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Two-Part Study of CLE-100 as an Adjunct Therapy in Subjects With Major Depressive Disorder
In Brief
A Phase 2 clinical trial evaluating CLE-100 and placebo for Adjunctive Treatment of Major Depressive Disorder. Completed, enrolled 146 participants across 46 sites in 2 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesPuerto Rico, United States
Collaborators--
Timeline
Phase 2CompletedFinished
2020202120222023202420252026
Enrollment StartSep 2019
First PostedSep 2019
Primary CompletionSep 2022
Study CompletionOct 2022
TodayJul 2026
First PostedSep 26, 2019
Enrollment StartSep 5, 2019
Primary CompletionSep 21, 2022
Study CompletionOct 5, 2022
TodayJul 2, 2026
Enrollment to primary: 3.0 yearsPosted 6.8 years ago
Interventions
CLE-100drug
1 tablet of CLE-100 administered once daily
placebodrug
1 tablet of placebo administered once daily