NCT04959032

Lumateperone for the Prevention of Relapse in Patients With Schizophrenia

A Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Lumateperone for the Prevention of Relapse in Patients With Schizophrenia

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 228 (actual)
• Sponsor: Intra-Cellular Therapies, Inc. · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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).

Detailed description

The study will be conducted in the following 5 phases: * A no-drug Screening Phase up to 7 days in duration during which patient eligibility will be assessed; * A 6-week, open-label Run-in Phase (RIP) during which all patients will receive oral lumateperone 42 mg/day; * A 12-week, open-label Stabilization Phase (SP) during which all patients will receive oral lumateperone 42 mg/day; * A Double-blind Treatment Phase (DBTP) 26 weeks in duration during which patients receive either lumateperone 42 mg or placebo (1:1 ratio); * A 2-week Safety Follow-up (SFU) Phase.

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	Lumateperone 42 mg	Lumateperone 42 mg capsules administered orally, once daily.
DRUG	Placebo	Matching capsules administered orally, once daily.

Timeline

• Start date: 2021-07-08
• Primary completion: 2024-07-25
• Completion: 2024-08-07
• First posted: 2021-07-12
• Last updated: 2024-11-07

Locations

43 sites across 4 countries: United States, Bulgaria, Poland, Serbia

Regulatory

• FDA-regulated drug study