drugset / Trial / NCT04959032

Lumateperone for the Prevention of Relapse in Patients With Schizophrenia

NCT04959032 ↗

Phase 3 Completed 592 enrolled Intra-Cellular Therapies, Inc.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group, fixed-dose study in adult patients with a primary diagnosis of schizophrenia according to criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, (DSM-5).

Timeline

Start
2021-07-08
Primary completion
2024-07-25
Completion
2024-08-07

Outcome

Met primary endpoint

release “randomized withdrawal trial, which on the primary endpoint found time to relapse during the 26-week double-blind treatment phase was significantly longer” jnj.com ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Lumateperone Small molecule 42 mg Oral

Indications