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NCT05850689Phase 3RECRUITING

Study of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder

Study 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.

Conditions
Major Depressive Disorder
Interventions / Drugs
LumateperonePlacebo
View on ClinicalTrials.gov ↗
Sponsor
ITCI
Intra-Cellular Therapies
Neuroscience
D38/100
Study Details
Enrollment470 participants
Primary Completion—
Lead SponsorIntra-Cellular Therapies, Inc.
Data Retrieved2026-04-11 04:18:13.264707+00:00
What This Trial Means for Biotech Investors
Trial Phase Context

Phase 3 trials are pivotal studies with large patient populations (hundreds to thousands) designed to prove efficacy and safety for FDA submission. A successful Phase 3 readout is typically the last major hurdle before a New Drug Application (NDA) or BLA filing.

Status & Expected Data

Currently recruiting: the trial is enrolling patients. A data readout is not expected until after enrollment closes and the follow-up period is complete.

Enrolled: 470 participants
Sponsor Catalyst Profile

Intra-Cellular Therapies (ITCI) is the sponsoring company for this trial. BiotechSign currently grades this company D (38/100) based on composite catalyst signals across its full pipeline. This trial is one data point in that overall catalyst picture.

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