At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 812 enrolled
Drug / intervention
Lumateperonedrug
Likely dose
Lumateperone 42 mgfrom 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.
An Open-label, Multicenter Trial to Assess the Safety and Tolerability of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder
In Brief
A Phase 3 clinical trial evaluating Lumateperone for Major Depressive Disorder. Completed, enrolled 812 participants across 109 sites in 11 countries.
Detailed Summary
This is a multicenter, open-label, fixed dose, 26 week study of patients with MDD. Eligible patients from the lead-in studies will enter the Open-label Safety Study at the Screening/Baseline Visit (Visit 1/Day 1), at which point patient eligibility will be assessed and informed consent obtained.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMajor Depressive Disorder
CountriesBulgaria, Czechia, Finland, Germany, Hungary, India, Poland, Slovakia, South Korea, Sweden, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20222023202420252026
First PostedSep 2021
Enrollment StartOct 2021
Primary CompletionOct 2024
Study CompletionOct 2024
TodayJul 2026
First PostedSep 29, 2021
Enrollment StartOct 8, 2021
Primary CompletionOct 14, 2024
Study CompletionOct 23, 2024
TodayJul 2, 2026
Enrollment to primary: 3.0 yearsPosted 4.8 years ago
Interventions
Lumateperonedrug
Lumateperone 42 mg capsules administered orally, once daily