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TerminatedNCT01677182

Once a Day, TAK-375 (Ramelteon) Tablet for depression

This study was terminated in the United States, in the United Kingdom, in Bulgaria, .... It is testing Once a Day, TAK-375 (Ramelteon) Tablet for depression.

BipolarityDrugFrom 18 Years to 75 Years

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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 dateAugust 2012
Recruitment status
Terminated
Enrollment listed in the registry
535
Sponsor
Takeda
Sponsor type
Unknown or unclear
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, United Kingdom, Bulgaria, ...
Age range
From 18 Years to 75 Years
Official registry ID
NCT01677182
Official title
A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Once a Day, TAK-375 (Ramelteon) Tablet for Sublingual Administration (TAK-375SL Tablet) as an Adjunctive Therapy in the Treatment of Acute Depressive Episodes Associated With Bipolar 1 Disorder in Adult Subjects

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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.

Bulgaria · 10 sites
  • Burgas
    Burgas
    Site status: Not listed — confirm with the team
  • Kazanlak
    Kazanlak
    Site status: Not listed — confirm with the team
  • Lovech
    Lovech
    Site status: Not listed — confirm with the team
  • Novi Iskar
    Novi Iskar
    Site status: Not listed — confirm with the team
  • Pleven
    Pleven
    Site status: Not listed — confirm with the team
  • Plovdiv
    Plovdiv
    Site status: Not listed — confirm with the team
  • Rousse
    Rousse
    Site status: Not listed — confirm with the team
  • Sofia
    Sofia
    Site status: Not listed — confirm with the team
  • Tzerova Koria
    Tzerova Koria
    Site status: Not listed — confirm with the team
  • Varna
    Varna
    Site status: Not listed — confirm with the team
Czechia · 5 sites
  • Brno
    Brno
    Site status: Not listed — confirm with the team
  • Litoměřice
    Litoměřice
    Site status: Not listed — confirm with the team
  • Olomouc
    Olomouc
    Site status: Not listed — confirm with the team
  • Pilsen
    Pilsen
    Site status: Not listed — confirm with the team
  • Prague
    Prague
    Site status: Not listed — confirm with the team
Germany · 4 sites
  • Bochum
    Bochum, North Rhine-Westphalia
    Site status: Not listed — confirm with the team
  • Berlin
    Berlin, State of Berlin
    Site status: Not listed — confirm with the team
  • Berlin
    Berlin
    Site status: Not listed — confirm with the team
  • Westerstede
    Westerstede
    Site status: Not listed — confirm with the team
Poland · 2 sites
  • Bialystok
    Bialystok
    Site status: Not listed — confirm with the team
  • Choroszcz
    Choroszcz
    Site status: Not listed — confirm with the team
Romania · 11 sites
  • Oradea
    Oradea, Bihor County
    Site status: Not listed — confirm with the team
  • Cluj-Napoca
    Cluj-Napoca, Cluj
    Site status: Not listed — confirm with the team
  • Craiova
    Craiova, Dolj
    Site status: Not listed — confirm with the team
  • Targoviste
    Targoviste, Dâmbovița County
    Site status: Not listed — confirm with the team
  • Bucharest
    Bucharest, Romania
    Site status: Not listed — confirm with the team
  • Arad
    Arad
    Site status: Not listed — confirm with the team
  • Bucharest
    Bucharest
    Site status: Not listed — confirm with the team
  • Cluj-Napoca
    Cluj-Napoca
    Site status: Not listed — confirm with the team
  • Craiova
    Craiova
    Site status: Not listed — confirm with the team
  • Iași
    Iași
    Site status: Not listed — confirm with the team
  • Targoviste
    Targoviste
    Site status: Not listed — confirm with the team
Russia · 11 sites
  • Talagi
    Talagi, Arkhangelskaya oblast
    Site status: Not listed — confirm with the team
  • Orenburg
    Orenburg, Orenburg Oblast
    Site status: Not listed — confirm with the team
  • Staritsa Settlement
    Staritsa Settlement, Orenburg Oblast
    Site status: Not listed — confirm with the team
  • Saint Petersburg
    Saint Petersburg, Sankt-Peterburg
    Site status: Not listed — confirm with the team
  • Town. Tonnelniy
    Town. Tonnelniy, Stavropol Region
    Site status: Not listed — confirm with the team
  • Arkhangelsk
    Arkhangelsk
    Site status: Not listed — confirm with the team
  • Moscow
    Moscow
    Site status: Not listed — confirm with the team
  • Nizhny Novgorod
    Nizhny Novgorod
    Site status: Not listed — confirm with the team
  • Saint Petersburg
    Saint Petersburg
    Site status: Not listed — confirm with the team
  • Smolensk
    Smolensk
    Site status: Not listed — confirm with the team
  • Stavropol
    Stavropol
    Site status: Not listed — confirm with the team
Serbia · 7 sites
  • Belgrade
    Belgrade, Serbia
    Site status: Not listed — confirm with the team
  • Kragujevac
    Kragujevac, Sumadija
    Site status: Not listed — confirm with the team
  • Novi Sad
    Novi Sad, Vojvodina
    Site status: Not listed — confirm with the team
  • Belgrade
    Belgrade
    Site status: Not listed — confirm with the team
  • Kragujevac
    Kragujevac
    Site status: Not listed — confirm with the team
  • Niš
    Niš
    Site status: Not listed — confirm with the team
  • Novi Kneževac
    Novi Kneževac
    Site status: Not listed — confirm with the team
Ukraine · 9 sites
  • Simferopol
    Simferopol, Autonomous Republic of Crimea
    Site status: Not listed — confirm with the team
  • Oleksandrivka, Kominternivske District
    Oleksandrivka, Kominternivske District, Odesa Oblast
    Site status: Not listed — confirm with the team
  • Simferopol
    Simferopol, The Autonomous Republic of Crimea
    Site status: Not listed — confirm with the team
  • Vinnytsia
    Vinnytsia, Vinnytsia Oblast
    Site status: Not listed — confirm with the team
  • Kharkiv
    Kharkiv
    Site status: Not listed — confirm with the team
  • Luhansk
    Luhansk
    Site status: Not listed — confirm with the team
  • Odesa
    Odesa
    Site status: Not listed — confirm with the team
  • Poltava
    Poltava
    Site status: Not listed — confirm with the team
  • Ternopil
    Ternopil
    Site status: Not listed — confirm with the team
United Kingdom · 4 sites
  • Oxford
    Oxford, Oxfordshire
    Site status: Not listed — confirm with the team
  • Birmingham
    Birmingham
    Site status: Not listed — confirm with the team
  • London
    London
    Site status: Not listed — confirm with the team
  • Newcastle upon Tyne
    Newcastle upon Tyne
    Site status: Not listed — confirm with the team
United States · 41 sites
  • Birmingham
    Birmingham, Alabama
    Site status: Not listed — confirm with the team
  • Anaheim
    Anaheim, California
    Site status: Not listed — confirm with the team
  • Glendale
    Glendale, California
    Site status: Not listed — confirm with the team
  • Imperial
    Imperial, California
    Site status: Not listed — confirm with the team
  • Los Angeles
    Los Angeles, California
    Site status: Not listed — confirm with the team
  • Oakland
    Oakland, California
    Site status: Not listed — confirm with the team
  • Oceanside
    Oceanside, California
    Site status: Not listed — confirm with the team
  • Pico Rivera
    Pico Rivera, California
    Site status: Not listed — confirm with the team
  • San Diego
    San Diego, California
    Site status: Not listed — confirm with the team
  • Stanford
    Stanford, California
    Site status: Not listed — confirm with the team
  • Hartford
    Hartford, Connecticut
    Site status: Not listed — confirm with the team
  • Coral Springs
    Coral Springs, Florida
    Site status: Not listed — confirm with the team
  • Deerfield Beach
    Deerfield Beach, Florida
    Site status: Not listed — confirm with the team
  • Gainesville
    Gainesville, Florida
    Site status: Not listed — confirm with the team
  • Jacksonville
    Jacksonville, Florida
    Site status: Not listed — confirm with the team
  • Maitland
    Maitland, Florida
    Site status: Not listed — confirm with the team
  • Oakland Park
    Oakland Park, Florida
    Site status: Not listed — confirm with the team
  • Orlando
    Orlando, Florida
    Site status: Not listed — confirm with the team
  • Tampa
    Tampa, Florida
    Site status: Not listed — confirm with the team
  • West Palm Beach
    West Palm Beach, Florida
    Site status: Not listed — confirm with the team
  • Chicago
    Chicago, Illinois
    Site status: Not listed — confirm with the team
  • Joliet
    Joliet, Illinois
    Site status: Not listed — confirm with the team
  • Naperville
    Naperville, Illinois
    Site status: Not listed — confirm with the team
  • Oak Brook
    Oak Brook, Illinois
    Site status: Not listed — confirm with the team
  • Lafayette
    Lafayette, Indiana
    Site status: Not listed — confirm with the team
  • Boston
    Boston, Massachusetts
    Site status: Not listed — confirm with the team
  • St Louis
    St Louis, Missouri
    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
  • Staten Island
    Staten Island, New York
    Site status: Not listed — confirm with the team
  • The Bronx
    The Bronx, New York
    Site status: Not listed — confirm with the team
  • Avon Lake
    Avon Lake, Ohio
    Site status: Not listed — confirm with the team
  • Cincinnati
    Cincinnati, Ohio
    Site status: Not listed — confirm with the team
  • Garfield Heights
    Garfield Heights, Ohio
    Site status: Not listed — confirm with the team
  • Mason
    Mason, Ohio
    Site status: Not listed — confirm with the team
  • Oklahoma City
    Oklahoma City, Oklahoma
    Site status: Not listed — confirm with the team
  • Memphis
    Memphis, Tennessee
    Site status: Not listed — confirm with the team
  • San Antonio
    San Antonio, Texas
    Site status: Not listed — confirm with the team
  • Bothell
    Bothell, Washington
    Site status: Not listed — confirm with the team
  • Spokane
    Spokane, Washington
    Site status: Not listed — confirm with the team
  • Waukesha
    Waukesha, Wisconsin
    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 Ramelteon, 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 75 Years. The criteria appear fairly specific, 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 Takeda, which appears to be unknown or unclear. 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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