At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 485 enrolled
Drug / intervention
Lumateperone +1 moredrug
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.
A Randomized, Double-Blind, Placebo-controlled Multicenter Study to Assess the Efficacy and Safety of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder
In Brief
A Phase 3 clinical trial evaluating Lumateperone and Placebo for Major Depressive Disorder. Completed, enrolled 485 participants across 54 sites in 6 countries.
Detailed Summary
This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group, fixed-dose study in patients with a primary diagnosis of MDD according to criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) who have an inadequate response to ongoing ADT.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMajor Depressive Disorder
CountriesBulgaria, Czechia, Hungary, India, Slovakia, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20222023202420252026
Enrollment StartJul 2021
First PostedAug 2021
Primary CompletionFeb 2024
Study CompletionFeb 2024
TodayJul 2026
First PostedAug 2, 2021
Enrollment StartJul 30, 2021
Primary CompletionFeb 22, 2024
Study CompletionFeb 27, 2024
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 4.9 years ago
Interventions
Lumateperonedrug
Lumateperone 42 mg capsules administered orally, once daily.
Placebodrug
Matching capsules administered orally, once daily.