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CompletedNCT04865835

A study 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 in the United States. It focuses on schizophrenia.

SchizophreniaOtherFrom 18 Years to 65 Years
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In plain English

Key information made simple

This summary needs review. Please check the official study record and contact the research team for details.

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.

Before joining

Questions to ask before joining

Study clarity

Things to check before joining

Study start dateStarted: May 12, 2021
Recruitment status
Completed
Estimated enrollment
Not clearly listed
Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Sponsor type
Pharmaceutical company
Study type
Other
Intervention type
Other / unclear
Study phase
Not clearly listed
Locations
United States
Age range
From 18 Years to 65 Years
Official registry ID
NCT04865835
Official title
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.
Official source
Official registry link

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Study ID: NCT04865835. We help you review the study, but cannot decide medical eligibility.
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

FAQ

Questions about this study

What is this study trying to understand?

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. The detailed objective is not always clearly listed in the public registry; the study team can confirm.

Why is the study type not clearly categorized?

The study type is not clearly categorized in the public registry. Focus on the objective, required tasks, visits, any intervention, and eligibility criteria, then ask the study team to confirm.

Do I need to want to stop or reduce tobacco use to participate?

The public registry appears to mention tobacco, nicotine, alcohol, cannabis, or another addiction-related topic. Ask the study team whether you need to want to stop, reduce, already be abstinent, or simply meet use-related criteria. Eligibility must be confirmed by the study team.

What would I likely need to do?

The public registry does not clearly describe all participation steps. The listed study locations suggest that at least part of participation may involve a physical site. Ask whether some steps can be done remotely.

What risks or points should I check?

The public registry does not make the main risk category clear. Ask the study team what activities are required, what could feel uncomfortable, how safety is monitored, and what happens if you want to stop. For any mental health study, also ask who to contact if you feel worse, whether participation may affect current treatment, whether you can stop, and who confirms eligibility.

Will I need to travel or attend in-person visits?

The listed study locations suggest that at least part of participation may involve a physical site. Ask which sites are open, how many visits are expected, whether any steps can be done remotely, and whether travel costs or compensation are listed.

Who is behind this study?

This study is sponsored by Otsuka Pharmaceutical Development & Commercialization, Inc., which appears to be a pharmaceutical company. Sponsor website: https://www.otsuka.co.jp/en/. If available, it can be useful to check the sponsor website, collaborators, investigator affiliation, and the official registry before deciding. HopeStage does not judge the quality of a sponsor or researcher, but helps you identify what to verify.

Can I still join this study?

The registry indicates that this study is completed. It may still be useful for understanding the research, but you are unlikely to be able to join.

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