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CompletedNCT01358357

Lurasidone Adjunctive to Lithium or Divalproex for Bipolarity type I

This study is completed in the United States, in Australia, in France, .... It is testing lurasidone Adjunctive to Lithium or Divalproex for Bipolarity type I.

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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In plain English

Key information made simple

What is this study testing?

This study is testing whether Lurasidone Adjunctive may be useful for adults experiencing bipolarity.

What would participation involve?

Participants may receive Lurasidone Adjunctive, attend study visits with the research team. The protocol may also involve randomization, placebo, or a comparison group. The registry lists locations in Argentina, in Australia, and in Bulgaria.

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 dateJune 2011
Recruitment status
Completed
Enrollment listed in the registry
965
Sponsor
Sumitomo Pharma America, 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, Australia, France, ...
Age range
Over 18 Years
Official registry ID
NCT01358357
Official title
A Randomized, Double-blind, Placebo-controlled, Flexible-dose, Parallel-group Study of Lurasidone Adjunctive to Lithium or Divalproex for the Prevention of Recurrence in Subjects With Bipolar I Disorder

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.

Argentina · 8 sites
  • Sanatorio Morra
    Córdoba, Córdoba Province
    Site status: Not listed — confirm with the team
  • Centro de Atencion E Invest. Clinica (CAICI)
    Rosario, Santa Fe Province
    Site status: Not listed — confirm with the team
  • Novain Neurociencias Group
    Buenos Aires
    Site status: Not listed — confirm with the team
  • Centro de Neuropsiquiatria
    Buenos Aires
    Site status: Not listed — confirm with the team
  • IPEM-Instituto de Prevención de las Enfermedades Mentales.
    Buenos Aires
    Site status: Not listed — confirm with the team
  • Instituto DAMCI
    Córdoba
    Site status: Not listed — confirm with the team
  • Clinica Privada de Salud Mental Santa Teresa de Avila
    La Plata
    Site status: Not listed — confirm with the team
  • Centro de Psiquiatria Biologica
    Mendoza
    Site status: Not listed — confirm with the team
Australia · 4 sites
  • The Lyell McEwin Hospital
    Elizabeth Vale, South Australia
    Site status: Not listed — confirm with the team
  • RWF Medic Pty Ltd as Trustee for Farnbach Family Trust at Neurotherapy Victoria
    Malvern, Victoria
    Site status: Not listed — confirm with the team
  • The Melbourne Clinic
    Richmond, Victoria
    Site status: Not listed — confirm with the team
  • Hollywood Medical Centre
    Fremantle, Western Australia
    Site status: Not listed — confirm with the team
Bulgaria · 6 sites
  • Psychiatry Dispensary
    Burgas
    Site status: Not listed — confirm with the team
  • University Multiprofiled Hospital for Active Treatment "Sveti Georgi"
    Plovdiv
    Site status: Not listed — confirm with the team
  • Regional Psychiatric Dispensary
    Rousse
    Site status: Not listed — confirm with the team
  • Multiprofiled Hospital for Active Treatment "Alexandrovska"
    Sofia
    Site status: Not listed — confirm with the team
  • Psychiatric Clinic, Military Medical Academy
    Sofia
    Site status: Not listed — confirm with the team
  • Multprofiled Hospital for Active Treatment "Sveta Marina"
    Varna
    Site status: Not listed — confirm with the team
Chile · 3 sites
  • CETEP
    Santiago
    Site status: Not listed — confirm with the team
  • Clinica Las Condes
    Santiago
    Site status: Not listed — confirm with the team
  • Psicomedica
    Santiago
    Site status: Not listed — confirm with the team
Croatia · 5 sites
  • Clinic Hospital Centre Rijeka Clinic for Psychiatry
    Rijeka
    Site status: Not listed — confirm with the team
  • Clinical Hospital Centre Zagreb
    Zagreb
    Site status: Not listed — confirm with the team
  • Klinicki Bolnicki Centar Zagreb-Rebro
    Zagreb
    Site status: Not listed — confirm with the team
  • University Hospital Sestremilosrdnice
    Zagreb
    Site status: Not listed — confirm with the team
  • University Hospital Centre Zagreb
    Zagreg
    Site status: Not listed — confirm with the team
Czechia · 11 sites
  • Saint Anne s.r.o.
    Brno
    Site status: Not listed — confirm with the team
  • Fakultni Nemocnice Brno
    Brno-Bohunice
    Site status: Not listed — confirm with the team
  • Psychiatricka ambulance
    Havířov
    Site status: Not listed — confirm with the team
  • Psychiatricka Iecebna U Honzicka
    Písek
    Site status: Not listed — confirm with the team
  • Clintrial s.r.o.
    Prague
    Site status: Not listed — confirm with the team
  • Psychiatricka Ambulance
    Prague
    Site status: Not listed — confirm with the team
  • Psychiaricka ambulance
    Prague
    Site status: Not listed — confirm with the team
  • Psychiatricka ambulance Prosek
    Prague
    Site status: Not listed — confirm with the team
  • Psychiatricke Centrum Praha
    Prague 8-Bohunice
    Site status: Not listed — confirm with the team
  • Psychosocialni Centrum
    Přerov
    Site status: Not listed — confirm with the team
  • Psychiatricka ambulance
    Ústí nad Labem
    Site status: Not listed — confirm with the team
France · 4 sites
  • CHS La Chartreuse-Pole 6
    Dijon
    Site status: Not listed — confirm with the team
  • Centre Hospitalier Specialise du Jura-Centre Medico Psychiatrique
    Dole
    Site status: Not listed — confirm with the team
  • Hopital Lapeyronie
    Montpellier
    Site status: Not listed — confirm with the team
  • CHRU de Nimes, Service de Psychiatrie adulte
    Nîmes
    Site status: Not listed — confirm with the team
Hungary · 7 sites
  • Obudai Egeszsegugyi Centurm Kft.
    Budapest
    Site status: Not listed — confirm with the team
  • Fovarosi Onkormanyzat Szent Istvan Korhaz es Szent Laszlo Korhaz
    Budapest
    Site status: Not listed — confirm with the team
  • Kutvolgyi Klinikai Tomb SOTE IIIsz Belgyogyaszati Klinika
    Budapest
    Site status: Not listed — confirm with the team
  • Nyiro Gyula Korhaz
    Budapest
    Site status: Not listed — confirm with the team
  • Fovarosi Onkormanyzat Nyiro Gyula Korhaz, I. Pszichiatria
    Budapest
    Site status: Not listed — confirm with the team
  • Petz Aladar Megyei Oktato Korhaz
    Győr
    Site status: Not listed — confirm with the team
  • Bekes Megyei Kepviselotestulet Pandy Kalman Korhaz
    Gyula
    Site status: Not listed — confirm with the team
Japan · 13 sites
  • Haruna Hospital
    Shibukawa, Gunma
    Site status: Not listed — confirm with the team
  • Goryokai Medical Corporation
    Sapporo, Hokkaido
    Site status: Not listed — confirm with the team
  • Sapporokousetsu Hospital
    Sapporo, Hokkaido
    Site status: Not listed — confirm with the team
  • Nagano Prefectural Mental Wellness Center-Komagane
    Komagane, Nagano
    Site status: Not listed — confirm with the team
  • Shonan Hospital
    Matsumoto-shi, Nagano
    Site status: Not listed — confirm with the team
  • Asakayama General Hospital
    Sakai, Osaka
    Site status: Not listed — confirm with the team
  • National Hospital Organization Hizen Psychiatric Center
    Kanzaki, Saga-ken
    Site status: Not listed — confirm with the team
  • Nishigahara Hospital
    Kita-ku, Tokyo
    Site status: Not listed — confirm with the team
  • Okehazama Hospital Fujita Kokoro Care Center
    Aichi
    Site status: Not listed — confirm with the team
  • Ongata Hospital
    Hachioji, Tokyo
    Site status: Not listed — confirm with the team
  • Yuge Hospital
    Kumamoto
    Site status: Not listed — confirm with the team
  • Arakaki Hospital
    Okinawa
    Site status: Not listed — confirm with the team
  • Kawada Hospital
    Toyama
    Site status: Not listed — confirm with the team
Poland · 5 sites
  • NZOZ Syntonia
    Gdynia
    Site status: Not listed — confirm with the team
  • NZOZ BioMed
    Kielce
    Site status: Not listed — confirm with the team
  • Wojewodzki Osrodek Lexznictwa Psychiatrycznego w Toruniu
    Torun
    Site status: Not listed — confirm with the team
  • Prywatny Gabinet Lekarski Jaroslaw Strzelec
    Tuszyn
    Site status: Not listed — confirm with the team
  • Przychodnia Lekarsko-Psychologiczna "Persona" Spolka Partnerska Lekarzy
    Wroclaw
    Site status: Not listed — confirm with the team
Russia · 6 sites
  • State Healthcare and Forensic Psychiatric Expertise Institution
    Izhevsk
    Site status: Not listed — confirm with the team
  • Nizhny Novgorod Regional State Institution of Healthcare
    Nizhny Novgorod
    Site status: Not listed — confirm with the team
  • St. Petersburg State Healthcare Institution (SPSHI)
    Saint Petersburg
    Site status: Not listed — confirm with the team
  • St.Petersburg State Healthcare Institution (SPSHI)
    Saint Petersburg
    Site status: Not listed — confirm with the team
  • St Petersburg State Government Healthcare Institution
    Saint Petersburg
    Site status: Not listed — confirm with the team
  • Mental Health Research Institute of Rams
    Tomsk
    Site status: Not listed — confirm with the team
Serbia · 5 sites
  • Clinical Centre of Serbia
    Belgrade
    Site status: Not listed — confirm with the team
  • Clinical Hospital Centre Dragisa Misovic
    Belgrade
    Site status: Not listed — confirm with the team
  • Psychiatric Clinic Clinical Center Kragujevac
    Kragujevac
    Site status: Not listed — confirm with the team
  • Clinical Centre Nis
    Niš
    Site status: Not listed — confirm with the team
  • Specialized Hospital for Psychiatric Diseased "Sveti Vracevi"
    Novi Kneževac
    Site status: Not listed — confirm with the team
Slovakia · 2 sites
  • Vseobecna Nemocnica Rimavska Sobota, NaP, n.o. Bratislava
    Rimavská Sobota
    Site status: Not listed — confirm with the team
  • Psychiatricka ambulancia
    Zlaté Moravce
    Site status: Not listed — confirm with the team
United States · 26 sites
  • Harmonex Neuroscience Research
    Dothan, Alabama
    Site status: Not listed — confirm with the team
  • Behavioral Research Specialists, LLC
    Glendale, California
    Site status: Not listed — confirm with the team
  • AXIS Clinical Trials
    Los Angeles, California
    Site status: Not listed — confirm with the team
  • Excell Research, Inc.
    Oceanside, California
    Site status: Not listed — confirm with the team
  • Stanford University School of Medicine Research Program VA Palo Alto Health Care System
    Palo Alto, California
    Site status: Not listed — confirm with the team
  • SF-CARE, Inc.
    San Francisco, California
    Site status: Not listed — confirm with the team
  • Neuropsychiatric Research Center of Orange County
    Santa Ana, California
    Site status: Not listed — confirm with the team
  • "Stanford University School of Medicine
    Stanford, California
    Site status: Not listed — confirm with the team
  • Florida Clinical Research LLC
    Bradenton, Florida
    Site status: Not listed — confirm with the team
  • Clinical Neuroscience Solutions, Inc.
    Jacksonville, Florida
    Site status: Not listed — confirm with the team
  • Galiz Research
    Miami Springs, Florida
    Site status: Not listed — confirm with the team
  • Clinical Neuroscience Solutions
    Orlando, Florida
    Site status: Not listed — confirm with the team
  • Atlanta Center for Medical Research
    Atlanta, Georgia
    Site status: Not listed — confirm with the team
  • Clinco
    Terre Haute, Indiana
    Site status: Not listed — confirm with the team
  • ActivMed Practices & Research Inc.
    Haverhill, Massachusetts
    Site status: Not listed — confirm with the team
  • Psych Care Consultants Research
    St Louis, Missouri
    Site status: Not listed — confirm with the team
  • Village Clinical Research Inc,
    New York, New York
    Site status: Not listed — confirm with the team
  • Finger Lakes Clinical Research
    Rochester, New York
    Site status: Not listed — confirm with the team
  • Charak Center for Health and Wellness
    Garfield Heights, Ohio
    Site status: Not listed — confirm with the team
  • Cutting Edge Research Groupd
    Oklahoma City, Oklahoma
    Site status: Not listed — confirm with the team
  • Suburban Research Associates
    Media, Pennsylvania
    Site status: Not listed — confirm with the team
  • Lincoln Research
    Lincoln, Rhode Island
    Site status: Not listed — confirm with the team
  • Carolina Clinical Trials, Inc.
    Charleston, South Carolina
    Site status: Not listed — confirm with the team
  • Clinical Neuroscience Solutions Inc.
    Memphis, Tennessee
    Site status: Not listed — confirm with the team
  • Psychoneuroendocrinology Research Group, Dept of Psychiatry, UT Southwestern Medical Center
    Dallas, Texas
    Site status: Not listed — confirm with the team
  • R/D Clinical Research, Inc.
    Lake Jackson, Texas
    Site status: Not listed — confirm with the team

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Study ID: NCT01358357. 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 Lurasidone, 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: 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 Sumitomo Pharma America, Inc., which appears to be a pharmaceutical company. 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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