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CompletedNCT00868452

Lurasidone Adjunctive to Lithium or Divalproex for depression

This study is completed in the United States, in France, in Czechia, .... It is testing lurasidone Adjunctive to Lithium or Divalproex for depression.

Bipolarity, DepressionDrugFrom 18 Years to 75 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.

Then choose your country and confirm availability with each study site.

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 Czechia, in France, and in Germany.

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 dateApril 2009
Recruitment status
Completed
Enrollment listed in the registry
348
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, France, Czechia, ...
Age range
From 18 Years to 75 Years
Official registry ID
NCT00868452
Official title
A Randomized, 6-Week, Double-Blind, Placebo- Controlled, Flexible-Dose, Parallel-Group Study of Lurasidone Adjunctive to Lithium or Divalproex for the Treatment of Bipolar I Depression

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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.

Czechia · 5 sites
  • Psychiatricka ambulance
    Brno - Mesto
    Site status: Not listed — confirm with the team
  • BIALBI s.r.o. Psychiatricke oddeleni
    Litoměřice
    Site status: Not listed — confirm with the team
  • Clintrial, s.r.o.
    Prague
    Site status: Not listed — confirm with the team
  • Medical Services Prague s.r.o.
    Prague
    Site status: Not listed — confirm with the team
  • Psychiatricka ambulance Prosek
    Prague
    Site status: Not listed — confirm with the team
France · 2 sites
  • Hopital Caremeau, Service de Psychiatrie A
    Nîmes
    Site status: Not listed — confirm with the team
  • Zans Ritter, Marcel
    Orvault
    Site status: Not listed — confirm with the team
Germany · 1 site
  • Jana Thomsen
    Berlin BE
    Site status: Not listed — confirm with the team
India · 11 sites
  • SV Medical College
    Tirupati, Andh Prad
    Site status: Not listed — confirm with the team
  • Vijayawada Institute of Mental Health and Neurosciences, Psychiatry
    Vijaywada, Andh Prad
    Site status: Not listed — confirm with the team
  • Samvedna Hospitals
    Ahmedabad, Gujarat
    Site status: Not listed — confirm with the team
  • Sheth Vadilal Sarabhai General Hospital
    Ahmedabad, Gujarat
    Site status: Not listed — confirm with the team
  • Mental Illness Treatment Rehabilitation Foundation (MITR)
    Ahmedabad, Gujarat
    Site status: Not listed — confirm with the team
  • Shree Hatkesh Health Foundation
    Jūnāgadh, Gujarat
    Site status: Not listed — confirm with the team
  • Spandana Nursing Home
    Bangalore, Karna
    Site status: Not listed — confirm with the team
  • Sujata Birla Hospital & Research Centre
    Nashik, Mahara
    Site status: Not listed — confirm with the team
  • Cosmos Hospitals-Delhi Psychiatry Center-Dept. of Psychiatry
    Delhi, National Capital Territory of Delhi
    Site status: Not listed — confirm with the team
  • R.K. Yadav Memorial Mental Health & De-Addiction Hospital
    Jaipur, Rajasthan
    Site status: Not listed — confirm with the team
  • Manobal Med. Research Centre
    Lucknow, Uttar Prad
    Site status: Not listed — confirm with the team
Poland · 3 sites
  • ZOZ Poradnia Zdrowia Psychicznego
    Chełmno
    Site status: Not listed — confirm with the team
  • Praktyka Lekarska Sensorium S.M.O.
    Skorzewo
    Site status: Not listed — confirm with the team
  • Wojewodzki Szpital Brodnowski SP ZOZ
    Warsaw
    Site status: Not listed — confirm with the team
Romania · 6 sites
  • Spitalul Clinic de Urgenta Militar Central "Prof. Dr. Carol" Psihiatrie
    Bucharest
    Site status: Not listed — confirm with the team
  • Spitalul Clinic de Psihaiatrie Prof. Dr. Alexandru Obregia
    Bucharest
    Site status: Not listed — confirm with the team
  • Spitalul Clinic Judetean de Urgenta Cluj
    Cluj-Napoca
    Site status: Not listed — confirm with the team
  • Spitalul Clinic de Neuropsihiatrie Craiova
    Craiova
    Site status: Not listed — confirm with the team
  • Spitalul Clinic de Neurologie si Psihiatrie Oradea
    Oradea
    Site status: Not listed — confirm with the team
  • Spitalul Judetean de Urgenta Pitesti Sectia de Psihiatric
    Piteşti
    Site status: Not listed — confirm with the team
Russia · 6 sites
  • Russian State Medical University
    Moscow
    Site status: Not listed — confirm with the team
  • Moscow Medical Academy named I.M. Sechenov
    Moscow
    Site status: Not listed — confirm with the team
  • City Psychiatric Hospital #2 of St. Nikolay Chudotvorets
    Saint Petersburg
    Site status: Not listed — confirm with the team
  • Bekhterev Scientific Research Psychoneurological Institute
    Saint Petersburg
    Site status: Not listed — confirm with the team
  • Psychoneurology Dispensary #4
    Saint Petersburg
    Site status: Not listed — confirm with the team
  • LLC International Medical Centre "SOGAZ"
    Saint Petersburg
    Site status: Not listed — confirm with the team
South Africa · 5 sites
  • Cape Trial Centre
    Cape Town, W. Cape
    Site status: Not listed — confirm with the team
  • Paarl Medical Centre
    Paarl, W. Cape
    Site status: Not listed — confirm with the team
  • Clinika
    Port Elizabeth, E. Cape
    Site status: Not listed — confirm with the team
  • Dey Clinic
    Pretoria, Gauteng
    Site status: Not listed — confirm with the team
  • Vereeniging Medi-Clinic
    Vereeniging, Free State
    Site status: Not listed — confirm with the team
Ukraine · 5 sites
  • Reg. Clinic Psych. Hosp., Dept 11, DNMU n.a.M. Gorkiy
    Donetsk
    Site status: Not listed — confirm with the team
  • Odesa Regional Psychoneurological Dispensary
    Odesa
    Site status: Not listed — confirm with the team
  • Reg. Ci.Ps.H.n.a.O.F.Maltsev, Fem.Ac.Gen.Ps. D.5B,HESIU UM
    Poltava
    Site status: Not listed — confirm with the team
  • CRI"Cl. Psych.Hosp.#1, Fem Psych.Dept.#2, Male Psych.Dept.#1
    Simferopol
    Site status: Not listed — confirm with the team
  • Reg. Psych. Hosp. n.a. O.Yuschenko, Dept. #21, VNMUn.a.M. Pirog
    Vinnitsia
    Site status: Not listed — confirm with the team
United States · 27 sites
  • Woodland International Research Inc.
    Little Rock, Arkansas
    Site status: Not listed — confirm with the team
  • South Coast Clinical Trials, Inc.
    Anaheim, California
    Site status: Not listed — confirm with the team
  • Catalina Research Institute
    Chino, California
    Site status: Not listed — confirm with the team
  • Synergy Escondido
    Escondido, California
    Site status: Not listed — confirm with the team
  • Collaborative Neuroscience Network Inc.,12772 Valley View Street
    Garden Grove, California
    Site status: Not listed — confirm with the team
  • Cedars-Sinai Medical Center
    Los Angeles, California
    Site status: Not listed — confirm with the team
  • University of California at Irvine Medical Center
    Orange, California
    Site status: Not listed — confirm with the team
  • CNRI - Los Angeles LLC,8309 Telegraph Road
    Pico Rivera, California
    Site status: Not listed — confirm with the team
  • CNRI - San Diego, LLC
    San Diego, California
    Site status: Not listed — confirm with the team
  • Stanford University School of Medicine
    Stanford, California
    Site status: Not listed — confirm with the team
  • University of Colorado
    Aurora, Colorado
    Site status: Not listed — confirm with the team
  • Depression and Anxiety Disorders Research Institue
    Tampa, Florida
    Site status: Not listed — confirm with the team
  • American Medical Research Inc.,1200 Harger Road Suite 415
    Oak Brook, Illinois
    Site status: Not listed — confirm with the team
  • American Medical Research, Inc., 1200 Harger Road Suite 415
    Oak Brook, Illinois
    Site status: Not listed — confirm with the team
  • J. Gary Booker, MD
    Shreveport, Louisiana
    Site status: Not listed — confirm with the team
  • Sheppard Pratt Health System,6501 North Charles Street
    Baltimore, Maryland
    Site status: Not listed — confirm with the team
  • Capital Clinical Research,5515 Security Lane, Suite 525
    Rockville, Maryland
    Site status: Not listed — confirm with the team
  • Midwest Research Group
    Saint Charles, Missouri
    Site status: Not listed — confirm with the team
  • Albuquerque Neuroscience Inc.,101 Hospital Loop, Suite 209
    Albuquerque, New Mexico
    Site status: Not listed — confirm with the team
  • Lake Charles Clinical Trials LLC,700 Spring Forest Road
    Raleigh, North Carolina
    Site status: Not listed — confirm with the team
  • Richard H. Weisler , M.D., PA.,& Associates, 700 Spring Forest Road, Suite 125
    Raleigh, North Carolina
    Site status: Not listed — confirm with the team
  • University of Cincinnati
    Cincinnati, Ohio
    Site status: Not listed — confirm with the team
  • Mood Disorders Program-UHCMC
    Cleveland, Ohio
    Site status: Not listed — confirm with the team
  • MetroHealth System
    Cleveland, Ohio
    Site status: Not listed — confirm with the team
  • Midwest Clinical research Center, One Elizabeth Place, Suite G-3
    Dayton, Ohio
    Site status: Not listed — confirm with the team
  • CRI Worldwide, LLC
    Philadelphia, Pennsylvania
    Site status: Not listed — confirm with the team
  • FutureSearch Clinical Trials, LLC., 4200 Marathon Blvd., Suite 200
    Austin, Texas
    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 lurasidone + (lithium or divalproex), Placebo + (lithium or divalproex). 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 75 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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