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Atypical Antipsychotic

Lumateperone for Schizophrenia and Bipolar Disorder

Phase 3
Recruiting
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 up to 6 months
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial is being conducted at multiple locations worldwide and will last for 26 weeks. It aims to evaluate the safety and tolerability of lumateperone in children with schizophrenia or bipolar disorder.

Who is the study for?
This trial is for children and teenagers with schizophrenia or bipolar disorder. Specific details about who can join are not provided, but typically participants must meet certain health standards and have a diagnosis of the conditions being studied.
What is being tested?
The study is testing Lumateperone, a medication intended to treat psychiatric conditions like schizophrenia and bipolar disorder in young people over a period of 26 weeks. It's an open-label trial, meaning both the researchers and participants know what treatment is being given.
What are the potential side effects?
While specific side effects for Lumateperone in this age group aren't listed here, common ones may include sleepiness, dizziness, nausea, and changes in weight or appetite. Side effects vary from person to person.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incidence of Common Adverse Events

Side effects data

From 2019 Phase 3 trial • 381 Patients • NCT03249376
18%
Headache
9%
Somnolence
6%
Nauseau
5%
Dizziness
1%
Mania
100%
80%
60%
40%
20%
0%
Study treatment Arm
Lumateperone
Placebo

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups
Experimental Treatment
Group I: LumateperoneExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lumateperone
2021
Completed Phase 3
~2650

Find a Location

Who is running the clinical trial?

Intra-Cellular Therapies, Inc.Lead Sponsor
40 Previous Clinical Trials
10,232 Total Patients Enrolled
11 Trials studying Schizophrenia
1,988 Patients Enrolled for Schizophrenia
~333 spots leftby Dec 2027
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.
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