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CompletedNCT00261443

Lithium or Valproate with placebo (PBO) for Bipolarity

This study is completed in the United States, in France, in Brazil, .... It is testing Lithium or Valproate with placebo (PBO) for Bipolarity.

BipolarityDrugOver 18 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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  • 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?

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Study start dateSeptember 2005
Recruitment status
Completed
Enrollment listed in the registry
1,270
Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Sponsor type
Pharmaceutical company
Study type
Drug
Intervention type
Medication / drug
Study phase
Phase 4Usually happens after approval, to monitor real-world use, safety, and longer-term outcomes.
Locations
United States, France, Brazil, ...
Age range
Over 18 Years
Official registry ID
NCT00261443
Official title
Efficacy of Aripiprazole in Combination With Lithium or Valproate in the Long-Term Maintenance Treatment of Bipolar I Disorder in Outpatients Partially Nonresponsive to Lithium or Valproate Monotherapy

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.

Brazil · 6 sites
  • Local Institution
    Salvador, Estado de Bahia
    Site status: Not listed — confirm with the team
  • Local Institution
    Aparecida de Goinia, Goiás
    Site status: Not listed — confirm with the team
  • Local Institution
    Pelotas, Rio Grande do Sul
    Site status: Not listed — confirm with the team
  • Local Institution
    Rio de Janeiro
    Site status: Not listed — confirm with the team
  • Local Institution
    São Paulo
    Site status: Not listed — confirm with the team
  • Local Institution
    São Paulo
    Site status: Not listed — confirm with the team
Bulgaria · 2 sites
  • Local Institution
    Burgas
    Site status: Not listed — confirm with the team
  • Local Institution
    Rousse
    Site status: Not listed — confirm with the team
Croatia · 4 sites
  • Local Institution
    Rijeka
    Site status: Not listed — confirm with the team
  • Local Institution
    Split
    Site status: Not listed — confirm with the team
  • Local Institution
    Zadar
    Site status: Not listed — confirm with the team
  • Local Institution
    Zagreb
    Site status: Not listed — confirm with the team
Czechia · 7 sites
  • Local Institution
    Brno
    Site status: Not listed — confirm with the team
  • Local Institution
    Brno
    Site status: Not listed — confirm with the team
  • Local Institution
    Havířov
    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
    Přerov
    Site status: Not listed — confirm with the team
France · 9 sites
  • Local Institution
    Nantes, Cedex 01
    Site status: Not listed — confirm with the team
  • Local Institution
    Dole
    Site status: Not listed — confirm with the team
  • Local Institution
    Hénin-Beaumont
    Site status: Not listed — confirm with the team
  • Local Institution
    Jonzac
    Site status: Not listed — confirm with the team
  • Local Institution
    La Seyne-sur-Mer
    Site status: Not listed — confirm with the team
  • Local Institution
    Marseille
    Site status: Not listed — confirm with the team
  • Local Institution
    Nantes
    Site status: Not listed — confirm with the team
  • Local Institution
    Nîmes
    Site status: Not listed — confirm with the team
  • Local Institution
    Rennes
    Site status: Not listed — confirm with the team
India · 14 sites
  • Local Institution
    Hyderabad, Andhra Pradesh
    Site status: Not listed — confirm with the team
  • Local Institution
    Ahmedabad, Gujarat
    Site status: Not listed — confirm with the team
  • Local Institution
    Ahmedabad, Gujarat
    Site status: Not listed — confirm with the team
  • Local Institution
    Kalyan (West), Maharashtra
    Site status: Not listed — confirm with the team
  • Local Institution
    Nāgūr, Maharashtra
    Site status: Not listed — confirm with the team
  • Local Institution
    Pune, Maharashtra
    Site status: Not listed — confirm with the team
  • Local Institution
    Mangalore, Manipal
    Site status: Not listed — confirm with the team
  • Local Institution
    Mumbai, Sion (W)
    Site status: Not listed — confirm with the team
  • Local Institution
    Delhi
    Site status: Not listed — confirm with the team
  • Local Institution
    Hyderabad
    Site status: Not listed — confirm with the team
  • Local Institution
    Mumbai
    Site status: Not listed — confirm with the team
  • Local Institution
    Mumbai
    Site status: Not listed — confirm with the team
  • Local Institution
    New Delhi
    Site status: Not listed — confirm with the team
  • Local Institution
    New Delhi
    Site status: Not listed — confirm with the team
Russia · 7 sites
  • Local Institution
    Izhevsk
    Site status: Not listed — confirm with the team
  • Local Institution
    Moscow
    Site status: Not listed — confirm with the team
  • Local Institution
    Nizhny Novgorod
    Site status: Not listed — confirm with the team
  • Local Institution
    Saint Petersburg
    Site status: Not listed — confirm with the team
  • Local Institution
    Saint Petersburg
    Site status: Not listed — confirm with the team
  • Local Institution
    Saratov
    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
    Pretoria, Gauteng
    Site status: Not listed — confirm with the team
  • Local Institution
    Berea, KwaZulu-Natal
    Site status: Not listed — confirm with the team
  • Local Institution
    Durban, KwaZulu-Natal
    Site status: Not listed — confirm with the team
  • Local Institution
    Cape Town, Western Cape
    Site status: Not listed — confirm with the team
  • Local Institution
    Paarl, Western Cape
    Site status: Not listed — confirm with the team
United States · 29 sites
  • Tuscaloosa Va Medical Center
    Tuscaloosa, Alabama
    Site status: Not listed — confirm with the team
  • Pravin Kansagra, M.D.
    Anaheim, California
    Site status: Not listed — confirm with the team
  • Psychopharmacology Research Network Of Torrance
    Cerritos, California
    Site status: Not listed — confirm with the team
  • Atp Clinical Research, Inc.
    Costa Mesa, California
    Site status: Not listed — confirm with the team
  • Us Clinical Research Centers, Llc
    Costa Mesa, California
    Site status: Not listed — confirm with the team
  • Va Long Beach Healthcare System
    Long Beach, California
    Site status: Not listed — confirm with the team
  • Synergy Clinical Research Center
    National City, California
    Site status: Not listed — confirm with the team
  • University Of California, Irvine Medical Center
    Orange, California
    Site status: Not listed — confirm with the team
  • Clinical Neuroscience Solutions, Inc.
    Orlando, Florida
    Site status: Not listed — confirm with the team
  • University Of South Florida
    Tampa, Florida
    Site status: Not listed — confirm with the team
  • Carman Research
    Smyrna, Georgia
    Site status: Not listed — confirm with the team
  • University Of Massachusetts Medical School
    Worcester, Massachusetts
    Site status: Not listed — confirm with the team
  • Psych Care Consultants Research
    St Louis, Missouri
    Site status: Not listed — confirm with the team
  • Cns Research Institute, P.C.
    Clementon, New Jersey
    Site status: Not listed — confirm with the team
  • Neuropsychiatric Research Associates
    New York, New York
    Site status: Not listed — confirm with the team
  • Behavioral Medical Research Of Staten Island
    Staten Island, New York
    Site status: Not listed — confirm with the team
  • Richmond Behavioral Associates
    Staten Island, New York
    Site status: Not listed — confirm with the team
  • Psychiatry And Clinical Research
    Raleigh, North Carolina
    Site status: Not listed — confirm with the team
  • Rakesh Ranjan, Md & Associates, Inc.
    Beachwood, Ohio
    Site status: Not listed — confirm with the team
  • University Of Cincinnati Medical Center
    Cincinnati, Ohio
    Site status: Not listed — confirm with the team
  • Metro Health Medical Center
    Cleveland, Ohio
    Site status: Not listed — confirm with the team
  • Midwest Clinical Research Center
    Dayton, Ohio
    Site status: Not listed — confirm with the team
  • Portland Va Medical Center
    Portland, Oregon
    Site status: Not listed — confirm with the team
  • Senior Adults Specialty Research, Inc.
    Austin, Texas
    Site status: Not listed — confirm with the team
  • Futuresearch Trials
    Dallas, Texas
    Site status: Not listed — confirm with the team
  • Insite Clinical Research
    DeSoto, Texas
    Site status: Not listed — confirm with the team
  • Red Oak Psychiatry Associates, Pa
    Houston, Texas
    Site status: Not listed — confirm with the team
  • University Of Utah School Of Medicine
    Salt Lake City, Utah
    Site status: Not listed — confirm with the team
  • Northwest Clinical Research Center
    Bellevue, Washington
    Site status: Not listed — confirm with the team

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Study ID: NCT00261443. We help you review the study, but cannot decide medical eligibility.
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 Lithium or Valproate with placebo (PBO), Lithium or Valproate with Aripiprazole. Phase 4 studies usually happen after treatment approval, to monitor real-world use.

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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