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Atypical Antipsychotic
Cohort 4: LAI Lumateperone 100 or 200 mg SC in the outer area of the upper arm for Schizophrenia
Phase 1
Waitlist Available
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 between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 7 weeks postdose
Awards & highlights
Study Summary
This study is evaluating whether a new drug may help treat schizophrenia.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 7 weeks postdose
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 7 weeks postdose
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Pharmacokinetics: Area under the plasma concentration-time curve (AUC0-t,BR) of lumateperone and metabolites during burst-release phase
Pharmacokinetics: Area under the plasma concentration-time curve (AUC0-t,SR) of lumateperone and metabolites during sustained-release phase
Pharmacokinetics: Area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC0-inf) of lumateperone and metabolites
+8 moreSecondary outcome measures
Change from baseline in Abnormal Involuntary Movement Scale
Change from baseline in ECG QT Interval
Change from baseline in Systolic and Diastolic Blood Pressure
+8 moreTrial Design
4Treatment groups
Experimental Treatment
Group I: Cohort 4: LAI Lumateperone 100 or 200 mg SC in the outer area of the upper armExperimental Treatment1 Intervention
Group II: Cohort 3: LAI Lumateperone 200 mg SC in the abdomenExperimental Treatment1 Intervention
Group III: Cohort 2: LAI Lumateperone 100 mg SC in the abdomenExperimental Treatment1 Intervention
Group IV: Cohort 1: LAI Lumateperone 50 mg SC in the abdomenExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lumateperone Long-Acting Injectable
2020
Completed Phase 1
~40
Find a Location
Who is running the clinical trial?
Intra-Cellular Therapies, Inc.Lead Sponsor
30 Previous Clinical Trials
7,494 Total Patients Enrolled
10 Trials studying Schizophrenia
2,351 Patients Enrolled for Schizophrenia
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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