CompletedNCT06627413

Safety, Tolerability, and Pharmacokinetics of Lumateperone Long-Acting Injectable Formulations in Patients With Schizophrenia or Schizoaffective Disorder

This study is completed. It focuses on schizophrenia and currently lists study information in the United States.

SchizophreniaOtherFrom 18 Years to 55 Years

In plain English

Key information made simple

This study exists to better understand the safety of this type of care and how manageable it feels in practice. Researchers are trying to understand how people respond to this type of care in practice and what may need to be adjusted. For people living with Schizophrenia, the gap between what sounds good on paper and what works in daily life is often important. If the findings are useful, they could help future care become more targeted, practical, and easier to trust. Taking part helps build the evidence that can improve understanding and care for others over time.

What to expect

Your next step

The official record suggests in-person participation through a lab, with sites including Clinical Site 2 in Los Alamitos, Clinical Site 3 in Atlanta, and Clinical Site 4 in Decatur. Participation appears to involve a study treatment together with follow-up visits and routine safety or progress checks. The main fit is usually matching the main diagnosis and having a stable enough treatment background for the study, while common reasons not to take part include safety concerns that need urgent care first and other factors that could make participation unsuitable. This is an early-stage study, which usually means a smaller group and a focus on learning how the approach behaves.

Public study data

Key study information

Condition: Schizophrenia or Schizoaffective
Study status: Completed
Sponsor / lead affiliation: Intra-Cellular Therapies, Inc.
Location / country: United States
Registry: ClinicalTrials.gov

Why this study may matter

This study may matter because it adds public evidence around schizophrenia. HopeStage presents it as a starting point for understanding the study, checking the official source, and preparing questions with a care team.

Before joining

Questions to ask before joining

What are the exact eligibility criteria, and what could exclude someone?
How many visits, assessments, or follow-ups are expected, and over what period?
What risks, side effects, practical burdens, or alternatives should be understood first?
Who should be contacted to confirm locations, timing, compensation, and next steps?

Official source

Registry reference

This page links back to the public source record so people can verify details directly with the registry and research team.

If you want the full study description, eligibility criteria, locations, and sponsor information in the original format, this is the place to check before taking the next step.

Open source record

Need help deciding?

Ask HopeStage to review this study with me

This form records your interest so HopeStage can follow up with practical guidance. It is not a medical eligibility decision and it does not guarantee a study spot.

Study reference: NCT06627413. We only ask for your email here. HopeStage can help you review the study, but this is not a medical eligibility decision.

In practice

For you

Taking part may give access to a new approach being evaluated.

It requires regular visits and structured follow-up.

Requires travel, with in-person participation in United States.

Important

Not medical advice

Information from public sources. Are you the study sponsor? Contact us to update this page: hi@hopestage.com

Study clarity

Things to check before joining

Sponsor: Intra-Cellular Therapies, Inc.
Sponsor type: Other organization
Main activity: observational follow-up
Intervention: Not available
Time commitment: long follow-up or multiple visits
Study phase: Not available
Enrollment: Not available
Recruitment status: Completed
Source: Official registry link

FAQ

Questions about this study

What is Safety, Tolerability, and Pharmacokinetics of Lumateperone Long-Acting Injectable Formulations in Patients With Schizophrenia or Schizoaffective Disorder?

This study is exploring observational follow-up for people with schizophrenia. Participants may complete study visits, assessments, or follow-up activities defined by the research team. Direct benefit is not guaranteed.

Who is behind this study, and what type of sponsor is it?

This study is sponsored by Intra-Cellular Therapies, Inc.. Based on the sponsor name or official registry information, it appears to be another type of organization. You should verify the details in the official registry record.

What does participation involve, what phase is it, and what should I ask about safety?

This study may involve observational follow-up, study visits, and assessments. The time commitment is long follow-up or multiple visits. The study phase is not available in HopeStage data. Check the official source record to see whether a phase is listed. Enrollment is not available in HopeStage data. HopeStage cannot say whether a study is safe or right for you. Before joining, ask the research team about possible risks, time commitment, visits, side effects, compensation, safety monitoring, and whether participation may affect your current care.

Where can I verify the study details?

Use the official source record linked on this page to check the full study description, recruitment status, eligibility criteria, locations, sponsor information, phase, enrollment, contact details, and any listed risks or requirements.