CompletedNCT04865835

A Clinical Trial Study to Determine the Effect of an Investigational Drug (SEP-363856) Has on the Way That the Drug Metformin Travels Through the Body in People With Schizophrenia.

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

SchizophreniaOtherFrom 18 Years to 65 Years

In plain English

Key information made simple

This study exists to see whether acceptance and commitment therapy, a talking treatment, can play a useful role in care. Researchers are trying to understand whether acceptance and commitment therapy, a talking treatment, can give earlier or clearer feedback during care. For people living with Schizophrenia, being understood earlier and more clearly can shape the whole care journey. If the findings are useful, they could lead to earlier recognition and more informed decisions later on. 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 clinic, with sites including At Fort Lauderdale Behavioral Health Center in Oakland Park and Hassman Research Institute in Marlton. Participation appears to involve using a digital tool or support program and giving feedback through check-ins or assessments. The main fit is usually matching the main diagnosis and being able to follow the planned visits or tasks, while common reasons not to take part include active substance or alcohol problems that could affect the results. 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
Study status: Completed
Sponsor / lead affiliation: Otsuka Pharmaceutical Development & Commercialization, 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: NCT04865835. 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 help clarify how this condition is measured or understood.

It requires regular follow-up, often through questionnaires or interviews.

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: Otsuka Pharmaceutical Development & Commercialization, Inc.
Sponsor type: Pharmaceutical company
Main activity: digital app or tool
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 A Clinical Trial Study to Determine the Effect of an Investigational Drug (SEP-363856) Has on the Way That the Drug Metformin Travels Through the Body in People With Schizophrenia.?

This study is exploring digital app or tool 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 Otsuka Pharmaceutical Development & Commercialization, Inc., a pharmaceutical company. Otsuka is a pharmaceutical company within the Otsuka group, with work across prescription medicines and healthcare products. The sponsor is based in Japan. Sponsor website: https://www.otsuka.co.jp/en/. You can verify the sponsor and study responsibility in the official registry record.

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

This study may involve digital app or tool, 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.