Lumateperone for the Prevention of Relapse in Patients With Schizophrenia

Status Active, not recruiting

Clinical Trial 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).

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04959032
Study type	Interventional
Source	Intra-Cellular Therapies, Inc.
Contact
Status	Active, not recruiting
Phase	Phase 3
Start date	July 8, 2021
Completion date	September 2024

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05039489` - A Study on the Brain Mechanism of cTBS in Improving Medication-resistant Auditory Hallucinations in Schizophrenia	N/A
Completed	`NCT05321602` - Study to Evaluate the PK Profiles of LY03010 in Patients With Schizophrenia or Schizoaffective Disorder	Phase 1
Completed	`NCT05111548` - Brain Stimulation and Cognitive Training - Efficacy	N/A
Completed	`NCT04503954` - Efficacy of Chronic Disease Self-management Program in People With Schizophrenia	N/A
Completed	`NCT02831231` - Pilot Study Comparing Effects of Xanomeline Alone to Xanomeline Plus Trospium	Phase 1
Completed	`NCT05517460` - The Efficacy of Auricular Acupressure on Improving Constipation Among Residents in Community Rehabilitation Center	N/A
Completed	`NCT03652974` - Disturbance of Plasma Cytokine Parameters in Clozapine-Resistant Treatment-Refractory Schizophrenia (CTRS) and Their Association With Combination Therapy	Phase 4
Recruiting	`NCT04012684` - rTMS on Mismatch Negativity of Schizophrenia	N/A
Recruiting	`NCT04481217` - Cognitive Factors Mediating the Relationship Between Childhood Trauma and Auditory Hallucinations in Schizophrenia	N/A
Completed	`NCT00212784` - Efficacy and Safety of Asenapine Using an Active Control in Subjects With Schizophrenia or Schizoaffective Disorder (25517)(P05935)	Phase 3
Completed	`NCT04092686` - A Clinical Trial That Will Study the Efficacy and Safety of an Investigational Drug in Acutely Psychotic People With Schizophrenia	Phase 3
Completed	`NCT01914393` - Pediatric Open-Label Extension Study	Phase 3
Recruiting	`NCT03790345` - Vitamin B6 and B12 in the Treatment of Movement Disorders Induced by Antipsychotics	Phase 2/Phase 3
Recruiting	`NCT05956327` - Insight Into Hippocampal Neuroplasticity in Schizophrenia by Investigating Molecular Pathways During Physical Training	N/A
Terminated	`NCT03209778` - Involuntary Memories Investigation in Schizophrenia	N/A
Terminated	`NCT03261817` - A Controlled Study With Remote Web-based Adapted Physical Activity (e-APA) in Psychotic Disorders	N/A
Completed	`NCT02905604` - Magnetic Stimulation of the Brain in Schizophrenia or Depression	N/A
Recruiting	`NCT05542212` - Intra-cortical Inhibition and Cognitive Deficits in Schizophrenia	N/A
Completed	`NCT04411979` - Effects of 12 Weeks Walking on Cognitive Function in Schizophrenia	N/A
Terminated	`NCT03220438` - TMS Enhancement of Visual Plasticity in Schizophrenia	N/A