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Atypical Antipsychotic

Lumateperone for 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

Study 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.Check my eligibility
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.See study design
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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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

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
~1360

Find a Location

Who is running the clinical trial?

Intra-Cellular Therapies, Inc.Lead Sponsor
30 Previous Clinical Trials
7,031 Total Patients Enrolled
5 Trials studying Bipolar Disorder
2,336 Patients Enrolled for Bipolar Disorder

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Do I meet the necessary criteria to participate in this research study?

"To be eligible for enrollment in this clinical trial, individuals must have a diagnosis of bipolar disorder and fall within the age range of 10 to 17 years old. The study aims to recruit approximately 500 participants."

Answered by AI

In how many medical institutions is this clinical examination currently being conducted?

"At present, this study is being conducted at 13 sites. These sites are located in various cities including San Diego, Colton, Cincinnati, and 10 other locations. To minimize travel requirements for participants, it is crucial to select the site nearest to their location when participating."

Answered by AI

Are individuals aged 60 and above eligible to participate in this clinical trial?

"To be eligible for participation in this clinical trial, patients must fall within the age range of 10 to 17 years. It is noteworthy that there are a total of 58 trials specifically targeting individuals under the age of 18, while there are 254 trials focused on participants aged 65 and above."

Answered by AI

Are there any ongoing efforts to enroll participants for this clinical trial at the moment?

"Indeed, the information available on clinicaltrials.gov indicates that this particular study is actively looking for eligible patients. The study was first posted on January 1st, 2024 and last updated on January 19th, 2024. Across a total of 13 sites, the aim is to enroll approximately 500 participants in this trial."

Answered by AI

Has Lumateperone received the official endorsement of the FDA?

"Based on the information provided, Lumateperone has a safety rating of 3 according to our team at Power. This assessment is due to its Phase 3 trial status, which indicates that there is existing efficacy data and multiple rounds of safety data supporting its use."

Answered by AI

What is the current number of subjects enrolled in this medical study?

"Indeed, the information provided on clinicaltrials.gov indicates that this trial is currently seeking eligible participants. The initial posting date for this study was January 1st, 2024, and it was most recently updated on January 19th, 2024. To complete the research successfully, a total of 500 patients will be recruited from thirteen different sites."

Answered by AI

Who else is applying?

What site did they apply to?
Clinical Site
What portion of applicants met pre-screening criteria?
Did not meet criteria

Why did patients apply to this trial?

I’ve tried medications that were not effective before and am open to trying a new drug.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
Safety and Tolerability Trial of Lumateperone in Pediatric Patients With Schizophrenia or Bipolar Disorder
2024. "Safety and Tolerability Trial of Lumateperone in Pediatric Patients With Schizophrenia or Bipolar Disorder". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06229210.
All > Miami > Indianapolis
~333 spots leftby Dec 2027
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