← Back to Search

Atypical Antipsychotic

Lumateperone 42 mg once daily for 5 days for Schizophrenia

Phase 1
Waitlist Available
Led By Clinical Site
Research Sponsored by Intra-Cellular Therapies, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up predose and multiple timepoints up to 24 hours postdose on day 1 and day 5
Awards & highlights

Study Summary

This study is evaluating whether a drug called lumateperone is safe and well tolerated in adolescents with schizophrenia or schizoaffective disorder.

Eligible Conditions
  • Schizophrenia
  • Pediatrics

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~predose and multiple timepoints up to 24 hours postdose on day 1 and day 5
This trial's timeline: 3 weeks for screening, Varies for treatment, and predose and multiple timepoints up to 24 hours postdose on day 1 and day 5 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Pharmacokinetics: AUC0-t
Pharmacokinetics: AUC0-tau
Pharmacokinetics: CL/F
+3 more
Secondary outcome measures
Change from baseline in Abnormal Involuntary Movement Scale (AIMS)
Change from baseline in ECG QT interval
Change from baseline in alanine aminotransferase
+5 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Lumateperone 42 mg once daily for 5 daysExperimental Treatment1 Intervention
Group II: Lumateperone 28 mg once daily for 5 daysExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lumateperone 28 mg
2021
Completed Phase 1
~30
Lumateperone 42 mg
2021
Completed Phase 1
~30

Find a Location

Who is running the clinical trial?

Intra-Cellular Therapies, Inc.Lead Sponsor
30 Previous Clinical Trials
7,505 Total Patients Enrolled
10 Trials studying Schizophrenia
2,362 Patients Enrolled for Schizophrenia
Clinical SitePrincipal InvestigatorHollywood, Florida, United States, 33024

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Safety, Tolerability, and Pharmacokinetics of Lumateperone in Pediatric Patients With Schizophrenia or Schizoaffective Disorder
2021. "Safety, Tolerability, and Pharmacokinetics of Lumateperone in Pediatric Patients With Schizophrenia or Schizoaffective Disorder". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04779177.
~6 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top