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CompletedNCT00665366

Aripiprazole Therapy for manic episodes in bipolarity type I

This study is completed in France, in Austria, in Czechia, .... It is testing aripiprazole Therapy for manic episodes in bipolarity type I.

BipolarityDrugOver 18 Years

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In plain English

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  • Recruitment and eligibility

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  • Visits and time

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

  • Costs and support

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Study start dateJune 2008
Recruitment status
Completed
Enrollment listed in the registry
493
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
France, Austria, Czechia, ...
Age range
Over 18 Years
Official registry ID
NCT00665366
Official title
A 12-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study To Evaluate the Efficacy and Safety of Adjunctive Aripiprazole Therapy in the Treatment of Mania in Bipolar I Disorder Patients Treated on Valproate or Lithium and in Need of Further Clinical Improvement

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

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

Austria · 2 sites
  • Local Institution
    Salzburg
    Site status: Not listed — confirm with the team
  • Local Institution
    Vienna
    Site status: Not listed — confirm with the team
Czechia · 5 sites
  • Local Institution
    Hradec Králové
    Site status: Not listed — confirm with the team
  • Local Institution
    Litoměřice
    Site status: Not listed — confirm with the team
  • Local Institution
    Prague
    Site status: Not listed — confirm with the team
  • Local Institution
    Prague
    Site status: Not listed — confirm with the team
  • Local Institution
    Prague
    Site status: Not listed — confirm with the team
France · 15 sites
  • Local Institution
    Beaupuy
    Site status: Not listed — confirm with the team
  • Local Institution
    Brumath
    Site status: Not listed — confirm with the team
  • Local Institution
    Château-Gontier
    Site status: Not listed — confirm with the team
  • Local Institution
    Clermont-Ferrand
    Site status: Not listed — confirm with the team
  • Local Institution
    Dijon
    Site status: Not listed — confirm with the team
  • Local Institution
    Dole
    Site status: Not listed — confirm with the team
  • Local Institution
    Jonzac
    Site status: Not listed — confirm with the team
  • Local Institution
    Le Vésinet
    Site status: Not listed — confirm with the team
  • Local Institution
    Montpellier
    Site status: Not listed — confirm with the team
  • Local Institution
    Nîmes
    Site status: Not listed — confirm with the team
  • Local Institution
    Paris
    Site status: Not listed — confirm with the team
  • Local Institution
    Reims
    Site status: Not listed — confirm with the team
  • Local Institution
    Saint-Nazaire
    Site status: Not listed — confirm with the team
  • Local Institution
    Sotteville-lès-Rouen
    Site status: Not listed — confirm with the team
  • Local Institution
    Strasbourg
    Site status: Not listed — confirm with the team
Germany · 2 sites
  • Local Institution
    Ellwangen
    Site status: Not listed — confirm with the team
  • Local Institution
    Ostfildern
    Site status: Not listed — confirm with the team
Greece · 4 sites
  • Local Institution
    Athens
    Site status: Not listed — confirm with the team
  • Local Institution
    Leros
    Site status: Not listed — confirm with the team
  • Local Institution
    Nea Ionia-Athens
    Site status: Not listed — confirm with the team
  • Local Institution
    Tripoli
    Site status: Not listed — confirm with the team
Hungary · 6 sites
  • Local Institution
    Budapest
    Site status: Not listed — confirm with the team
  • Local Institution
    Budapest
    Site status: Not listed — confirm with the team
  • Local Institution
    Budapest
    Site status: Not listed — confirm with the team
  • Local Institution
    Budapest
    Site status: Not listed — confirm with the team
  • Local Institution
    Győr
    Site status: Not listed — confirm with the team
  • Local Institution
    Gyula
    Site status: Not listed — confirm with the team
Italy · 11 sites
  • Local Institution
    Campobasso
    Site status: Not listed — confirm with the team
  • Local Institution
    Foggia
    Site status: Not listed — confirm with the team
  • Local Institution
    Foligno (Pg)
    Site status: Not listed — confirm with the team
  • Local Institution
    Genova
    Site status: Not listed — confirm with the team
  • Local Institution
    La Spezia
    Site status: Not listed — confirm with the team
  • Local Institution
    Milan
    Site status: Not listed — confirm with the team
  • Local Institution
    Naples
    Site status: Not listed — confirm with the team
  • Local Institution
    Pisa
    Site status: Not listed — confirm with the team
  • Local Institution
    Roma
    Site status: Not listed — confirm with the team
  • Local Institution
    Roma
    Site status: Not listed — confirm with the team
  • Local Institution
    Sant'Arsenio (Salerno)
    Site status: Not listed — confirm with the team
Poland · 6 sites
  • Local Institution
    Choroszcz
    Site status: Not listed — confirm with the team
  • Local Institution
    Gdansk
    Site status: Not listed — confirm with the team
  • Local Institution
    Krakow
    Site status: Not listed — confirm with the team
  • Local Institution
    Krakow
    Site status: Not listed — confirm with the team
  • Local Institution
    Poznan
    Site status: Not listed — confirm with the team
  • Local Institution
    Swiecie N/Wisla
    Site status: Not listed — confirm with the team
Romania · 3 sites
  • Local Institution
    Bucharest
    Site status: Not listed — confirm with the team
  • Local Institution
    Cluj-Nappoca
    Site status: Not listed — confirm with the team
  • Local Institution
    Iași
    Site status: Not listed — confirm with the team
Russia · 8 sites
  • Local Institution
    Khot'kovo
    Site status: Not listed — confirm with the team
  • Local Institution
    Krasnodar
    Site status: Not listed — confirm with the team
  • Local Institution
    Moscow
    Site status: Not listed — confirm with the team
  • Local Institution
    Moscow
    Site status: Not listed — confirm with the team
  • Local Institution
    Rostov-on-Don
    Site status: Not listed — confirm with the team
  • Local Institution
    Saint Petersburg
    Site status: Not listed — confirm with the team
  • Local Institution
    Samara
    Site status: Not listed — confirm with the team
  • Local Institution
    Tomsk
    Site status: Not listed — confirm with the team
South Africa · 5 sites
  • Local Institution
    Johannesburg, Gauteng
    Site status: Not listed — confirm with the team
  • Local Institution
    Soweto, Gauteng
    Site status: Not listed — confirm with the team
  • Local Institution
    Vereeniging, Gauteng
    Site status: Not listed — confirm with the team
  • Local Institution
    Pinetown, KwaZulu-Natal
    Site status: Not listed — confirm with the team
  • Local Institution
    Cape Town, Western Cape
    Site status: Not listed — confirm with the team
Spain · 3 sites
  • Local Institution
    Barcelona
    Site status: Not listed — confirm with the team
  • Local Institution
    Madrid
    Site status: Not listed — confirm with the team
  • Local Institution
    Murcia
    Site status: Not listed — confirm with the team
Türkiye · 3 sites
  • Local Institution
    Ankara
    Site status: Not listed — confirm with the team
  • Local Institution
    Antalya
    Site status: Not listed — confirm with the team
  • Local Institution
    Denizli
    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 Aripiprazole, Placebo, Lithium, Valproate. 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: Over 18 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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