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Lumateperone for the Prevention of Relapse in Patients With Schizophrenia

NCT04959032 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 228

Last updated 2024-11-07

No results posted yet for this study

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).

Conditions

Interventions

DRUG

Lumateperone 42 mg

Lumateperone 42 mg capsules administered orally, once daily.

DRUG

Placebo

Matching capsules administered orally, once daily.

Sponsors & Collaborators

  • Intra-Cellular Therapies, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-08
Primary Completion
2024-07-25
Completion
2024-08-07
FDA Drug
Yes

Countries

  • United States
  • Bulgaria
  • Poland
  • Serbia

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04959032 on ClinicalTrials.gov