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CompletedNCT01567527

Efficacy, Safety, and Tolerability of an Intramuscular Formulation of Aripiprazole (OPC-14597) as Maintenance Treatment in Bipolar I Patients

This study is completed. It focuses on bipolarity and currently lists study information in Canada, Japan, Poland, Romania, South Korea, Taiwan, and the United States.

BipolarityOtherFrom 18 Years to 65 Years
In plain English

Key information made simple

This study exists to see whether the medication OPC-14597 can make care clearer and more responsive. Researchers are trying to understand whether the medication OPC-14597 can better prevent setbacks and support longer-term stability. For people living with Bipolarity, 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 hospital. Participation appears to involve questionnaires, interviews, or regular check-ins about day-to-day experience. The main fit is usually being able to follow the planned visits or tasks and meeting the main study requirements, while common reasons not to take part include safety concerns that need urgent care first and active substance or alcohol problems that could affect the results. This is a later-stage study, which usually means a larger group and a closer look at how well the approach holds up.

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.

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In practice

For you

Taking part may help improve understanding of your condition.

It requires regular visits and structured follow-up.

Requires travel, with in-person participation in Canada.

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
medication or study treatment
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 Efficacy, Safety, and Tolerability of an Intramuscular Formulation of Aripiprazole (OPC-14597) as Maintenance Treatment in Bipolar I Patients?

This study is exploring medication or study treatment for people with bipolarity. 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 medication or study treatment, 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.

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