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CompletedNCT01567527

Efficacy, Safety, and Tolerability of an Intramuscular Depot Formulation of Aripiprazole for Bipolarity type I

This study is completed in the United States, in Canada, in Japan, .... It is testing efficacy, Safety, and Tolerability of an Intramuscular Depot Formulation of Aripiprazole for Bipolarity type I.

BipolarityDrugFrom 18 Years to 65 Years

The public registry lists this study as not currently recruiting. This page remains available for information. Check the official record for the latest status and explore other recruiting studies.

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In plain English

Key information made simple

What is this study testing?

This study is testing whether Intramuscular (IM) Depot Aripiprazole may be useful for adults experiencing bipolarity.

What would participation involve?

Participants may receive Intramuscular (IM) Depot Aripiprazole, attend study visits with the research team. The protocol may also involve randomization, placebo, or a comparison group. The registry lists locations in Canada, in Japan, and in Poland.

Who is it mainly for?

This study appears to be mainly for adults with bipolarity.

What should you check before joining?

Ask about the dose, safety monitoring, and possible side effects, whether there is placebo, randomization, or a comparison group, how many visits or travel steps are needed, the exact eligibility criteria.

Your next step

Check the study details

Check the official source, then confirm these points with the research team.

View official study record (opens in a new tab)

  • Recruitment and eligibility

    Is a site open, and who can take part?

  • Visits and time

    Where are visits, can any be remote, and how much time is needed?

  • Costs and support

    What costs, reimbursement or compensation apply?

Before joining

Questions to ask before joining

Study clarity

Things to check before joining

Study start dateAugust 2012
Recruitment status
Completed
Enrollment listed in the registry
731
Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Sponsor type
Pharmaceutical company
Study type
Drug
Intervention type
Medication / drug
Study phase
Phase 3Usually a larger study designed to confirm effectiveness and safety in a broader group.
Locations
United States, Canada, Japan, ...
Age range
From 18 Years to 65 Years
Official registry ID
NCT01567527
Official title
52-week, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of an Intramuscular Depot Formulation of Aripiprazole (OPC-14597) as Maintenance Treatment in Patients With Bipolar I Disorder

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Study ID: NCT01567527. We help you review the study, but cannot decide medical eligibility.

Check recruitment and locations

Recruitment checked against the registry by HopeStage on . Registry information can change. Always confirm availability with the research team.

View official study record (opens in a new tab)

The overall study status can differ from each site's status. Open a country to see its locations and their registry status.

Canada · 1 site
  • Chatham
    Chatham, Ontario
    Site status: Not listed — confirm with the team
Japan · 18 sites
  • Aizu-Wakamatsu
    Aizu-Wakamatsu, Fukushima
    Site status: Not listed — confirm with the team
  • Sapporo
    Sapporo, Hokkaido
    Site status: Not listed — confirm with the team
  • Morioka
    Morioka, Iwate
    Site status: Not listed — confirm with the team
  • Kawasaki-shi
    Kawasaki-shi, Kanagawa
    Site status: Not listed — confirm with the team
  • Yokohama
    Yokohama, Kanagawa
    Site status: Not listed — confirm with the team
  • Kashihara
    Kashihara, Nara
    Site status: Not listed — confirm with the team
  • Sakai
    Sakai, Osaka
    Site status: Not listed — confirm with the team
  • Sakai-shi
    Sakai-shi, Osaka
    Site status: Not listed — confirm with the team
  • Fukuoka
    Fukuoka
    Site status: Not listed — confirm with the team
  • Itabashi-bu
    Itabashi-bu
    Site status: Not listed — confirm with the team
  • Kanzaki-gun
    Kanzaki-gun
    Site status: Not listed — confirm with the team
  • Koriyama-shi
    Koriyama-shi
    Site status: Not listed — confirm with the team
  • Kumamoto
    Kumamoto
    Site status: Not listed — confirm with the team
  • Okinawa
    Okinawa
    Site status: Not listed — confirm with the team
  • Shinjuku-ku
    Shinjuku-ku
    Site status: Not listed — confirm with the team
  • Tokyo
    Tokyo
    Site status: Not listed — confirm with the team
  • Tottori
    Tottori
    Site status: Not listed — confirm with the team
  • Toyama
    Toyama
    Site status: Not listed — confirm with the team
Poland · 4 sites
  • Gdynia
    Gdynia, Pomeranian Voivodeship
    Site status: Not listed — confirm with the team
  • Bydgoszcz
    Bydgoszcz
    Site status: Not listed — confirm with the team
  • Chełmno
    Chełmno
    Site status: Not listed — confirm with the team
  • Choroszcz
    Choroszcz
    Site status: Not listed — confirm with the team
Romania · 3 sites
  • Targoviste
    Targoviste, Dyambovita
    Site status: Not listed — confirm with the team
  • Bucharest
    Bucharest
    Site status: Not listed — confirm with the team
  • Judet Lasi
    Judet Lasi
    Site status: Not listed — confirm with the team
South Korea · 5 sites
  • Anyang-si
    Anyang-si, Gyeonggi-do
    Site status: Not listed — confirm with the team
  • Goyang-si
    Goyang-si, Gyeonggi-do
    Site status: Not listed — confirm with the team
  • Daejeon
    Daejeon
    Site status: Not listed — confirm with the team
  • Jeju City
    Jeju City
    Site status: Not listed — confirm with the team
  • Seoul
    Seoul
    Site status: Not listed — confirm with the team
Taiwan · 3 sites
  • Keelung
    Keelung
    Site status: Not listed — confirm with the team
  • Taipei
    Taipei
    Site status: Not listed — confirm with the team
  • Taouyuan County
    Taouyuan County
    Site status: Not listed — confirm with the team
United States · 42 sites
  • Birmingham
    Birmingham, Alabama
    Site status: Not listed — confirm with the team
  • Springdale
    Springdale, Arkansas
    Site status: Not listed — confirm with the team
  • Beverly Hills
    Beverly Hills, California
    Site status: Not listed — confirm with the team
  • Costa Mesa
    Costa Mesa, California
    Site status: Not listed — confirm with the team
  • Escondido
    Escondido, California
    Site status: Not listed — confirm with the team
  • Garden Grove
    Garden Grove, California
    Site status: Not listed — confirm with the team
  • Los Angeles
    Los Angeles, California
    Site status: Not listed — confirm with the team
  • National City
    National City, California
    Site status: Not listed — confirm with the team
  • Oceanside
    Oceanside, California
    Site status: Not listed — confirm with the team
  • Orange
    Orange, California
    Site status: Not listed — confirm with the team
  • Pico Rivera
    Pico Rivera, California
    Site status: Not listed — confirm with the team
  • Riverside
    Riverside, California
    Site status: Not listed — confirm with the team
  • San Diego
    San Diego, California
    Site status: Not listed — confirm with the team
  • Temecula
    Temecula, California
    Site status: Not listed — confirm with the team
  • Torrance
    Torrance, California
    Site status: Not listed — confirm with the team
  • Lauderhill
    Lauderhill, Florida
    Site status: Not listed — confirm with the team
  • Leesburg
    Leesburg, Florida
    Site status: Not listed — confirm with the team
  • Melbourne
    Melbourne, Florida
    Site status: Not listed — confirm with the team
  • Oakland Park
    Oakland Park, Florida
    Site status: Not listed — confirm with the team
  • Atlanta
    Atlanta, Georgia
    Site status: Not listed — confirm with the team
  • Decatur
    Decatur, Georgia
    Site status: Not listed — confirm with the team
  • Smyrna
    Smyrna, Georgia
    Site status: Not listed — confirm with the team
  • Hoffman Estates
    Hoffman Estates, Illinois
    Site status: Not listed — confirm with the team
  • New Orleans
    New Orleans, Louisiana
    Site status: Not listed — confirm with the team
  • Rockville
    Rockville, Maryland
    Site status: Not listed — confirm with the team
  • Flowood
    Flowood, Mississippi
    Site status: Not listed — confirm with the team
  • Saint Charles
    Saint Charles, Missouri
    Site status: Not listed — confirm with the team
  • St Louis
    St Louis, Missouri
    Site status: Not listed — confirm with the team
  • Lincoln
    Lincoln, Nebraska
    Site status: Not listed — confirm with the team
  • Cherry Hill
    Cherry Hill, New Jersey
    Site status: Not listed — confirm with the team
  • Brooklyn
    Brooklyn, New York
    Site status: Not listed — confirm with the team
  • Buffalo
    Buffalo, New York
    Site status: Not listed — confirm with the team
  • New York
    New York, New York
    Site status: Not listed — confirm with the team
  • Cincinnati
    Cincinnati, Ohio
    Site status: Not listed — confirm with the team
  • Dayton
    Dayton, Ohio
    Site status: Not listed — confirm with the team
  • Oklahoma City
    Oklahoma City, Oklahoma
    Site status: Not listed — confirm with the team
  • Allentown
    Allentown, Pennsylvania
    Site status: Not listed — confirm with the team
  • Jenkintown
    Jenkintown, Pennsylvania
    Site status: Not listed — confirm with the team
  • Austin
    Austin, Texas
    Site status: Not listed — confirm with the team
  • Dallas
    Dallas, Texas
    Site status: Not listed — confirm with the team
  • Wichita Falls
    Wichita Falls, Texas
    Site status: Not listed — confirm with the team
  • Richmond
    Richmond, Virginia
    Site status: Not listed — confirm with the team
In practice

For you

Participation may contribute to research. Personal benefit is not guaranteed.

Ask the research team to explain the activities, time commitment, and follow-up involved.

Study sites are listed. Confirm the relevant site and any travel before making plans.

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

Does this study involve a medication?

This appears to be a medication / drug study involving Intramuscular (IM) Depot Aripiprazole, Intramuscular (IM) Depot Placebo. Phase 3 studies are usually larger and aim to confirm effectiveness and safety in a broader group.

Who might this study be for?

This study may concern people with bipolarity; age range: From 18 Years to 65 Years. The criteria appear fairly broad, but you should not assume you are eligible. The study team must confirm diagnosis, age, exclusions, available locations, and next steps.

What would I likely need to do?

You may need to take a study treatment and have regular medical follow-up. 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 side effects, interactions, or treatment changes should I check?

If the study involves a medication, ask whether it is already approved, experimental, or being tested for a new use. Check possible side effects, interactions with current treatment, dose changes, monitoring, and what happens if you feel worse. 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 public registry lists this study as not currently recruiting. This page remains available for information. Check the official record for the latest status and explore other recruiting studies.

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