TerminatedNCT01677182
Safety and Efficacy Study of Ramelteon (TAK-375) Tablets for Sublingual Administration (SL) in Adults With Bipolarity type I
This study evaluates the safety and effectiveness of Ramelteon for people with bipolarity.
Medication studyAges 18–75Multiple countries
Understand this study
What is this study about?
This study evaluates the safety and effectiveness of Ramelteon for people with bipolarity.
Who could participate?
This study is for people with bipolarity. Listed age limits: 18 years to 75 years. Other eligibility criteria apply.
- Listed locations
- Birmingham and 103 more locationsSee all locations and recruitment
- Study phase
- Phase 3Usually a larger study designed to confirm effectiveness and safety in a broader group.
What to know before participating
A point to clarify
This summary does not cover all risks or eligibility requirements. What risks or changes to my care would apply to me?
Things to check before joining
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
- 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
Show the full 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
Recruitment & locations
TerminatedThis badge reflects the study status reported by the registry. Check the registry for the latest information.
Birmingham, United States · Anaheim, United States · Glendale, United States
94 more locations
- Imperial, United States
- Los Angeles, United States
- Oakland, United States
- Oceanside, United States
- Pico Rivera, United States
- San Diego, United States
- Stanford, United States
- Hartford, United States
- Coral Springs, United States
- Deerfield Beach, United States
- Gainesville, United States
- Jacksonville, United States
- Maitland, United States
- Oakland Park, United States
- Orlando, United States
- Tampa, United States
- West Palm Beach, United States
- Chicago, United States
- Joliet, United States
- Naperville, United States
- Oak Brook, United States
- Lafayette, United States
- Boston, United States
- St Louis, United States
- Buffalo, United States
- New York, United States
- Staten Island, United States
- The Bronx, United States
- Avon Lake, United States
- Cincinnati, United States
- Garfield Heights, United States
- Mason, United States
- Oklahoma City, United States
- Memphis, United States
- San Antonio, United States
- Bothell, United States
- Spokane, United States
- Waukesha, United States
- Burgas, Bulgaria
- Kazanlak, Bulgaria
- Lovech, Bulgaria
- Novi Iskar, Bulgaria
- Pleven, Bulgaria
- Plovdiv, Bulgaria
- Rousse, Bulgaria
- Sofia, Bulgaria
- Tzerova Koria, Bulgaria
- Varna, Bulgaria
- Brno, Czechia
- Litoměřice, Czechia
- Olomouc, Czechia
- Pilsen, Czechia
- Prague, Czechia
- Bochum, Germany
- Berlin, Germany
- Westerstede, Germany
- Bialystok, Poland
- Choroszcz, Poland
- Oradea, Romania
- Cluj-Napoca, Romania
- Craiova, Romania
- Targoviste, Romania
- Bucharest, Romania
- Arad, Romania
- Iași, Romania
- Talagi, Russia
- Orenburg, Russia
- Staritsa Settlement, Russia
- Saint Petersburg, Russia
- Town. Tonnelniy, Russia
- Arkhangelsk, Russia
- Moscow, Russia
- Nizhny Novgorod, Russia
- Smolensk, Russia
- Stavropol, Russia
- Belgrade, Serbia
- Kragujevac, Serbia
- Novi Sad, Serbia
- Niš, Serbia
- Novi Kneževac, Serbia
- Simferopol, Ukraine
- Oleksandrivka, Kominternivske District, Ukraine
- Vinnytsia, Ukraine
- Kharkiv, Ukraine
- Luhansk, Ukraine
- Odesa, Ukraine
- Poltava, Ukraine
- Ternopil, Ukraine
- Oxford, United Kingdom
- Birmingham, United Kingdom
- London, United Kingdom
- Newcastle upon Tyne, United Kingdom
- Czechia
- Russia
Interested in joining this study?
Questions about this study
What is this study about?
This study evaluates the safety and effectiveness of Ramelteon for people with bipolarity.
Who is behind this study?
The study sponsor is Takeda.
Does this study involve medication?
Yes. The study involves medication, including Ramelteon and Placebo.
Who can participate?
This study is for people with bipolarity. Listed age limits: 18 years to 75 years. Other eligibility criteria apply.
Is this study still recruiting?
The registry lists this study as terminated.
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