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TerminatedNCT01467713

Efficacy and Safety of Ramelteon Sublingual as Adjunctive Therapy for Maintenance Treatment of Bipolarity type I

Medication studyAges 18–75Multiple countries
The study in practice

Understand this study

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 155 more locationsSee all locations and recruitment
Study phase
Phase 3Usually a larger study designed to confirm effectiveness and safety in a broader group.

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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?

Study clarity

Things to check before joining

Study start dateDecember 2011
Recruitment status
Terminated
Enrollment listed in the registry
642
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, Argentina, Chile, ...
Age range
From 18 Years to 75 Years
Official registry ID
NCT01467713
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-375SL as an Adjunctive Therapy to Treatment-as-Usual in the Maintenance Treatment of Bipolar I Disorder in Adult Patients

Recruitment & locations

Terminated

Birmingham, United States · Dothan, United States · Muscle Shoals, United States

151 more locations
  • Phoenix, United States
  • Little Rock, United States
  • Bellflower, United States
  • Costa Mesa, United States
  • Garden Grove, United States
  • Harbor City, United States
  • Huntington Park, United States
  • Irvine, United States
  • Lomita, United States
  • Long Beach, United States
  • Los Angeles, United States
  • Murrieta, United States
  • National City, United States
  • Oceanside, United States
  • Orange, United States
  • Paramount, United States
  • Rancho Cucamonga, United States
  • Redondo Beach, United States
  • Riverside, United States
  • Sacramento, United States
  • San Diego, United States
  • San Jose, United States
  • San Ramon, United States
  • Sherman Oaks, United States
  • Torrance, United States
  • Wildomar, United States
  • Colorado Springs, United States
  • Denver, United States
  • Norwalk, United States
  • Washington D.C., United States
  • Clearwater, United States
  • Coral Gables, United States
  • Coral Springs, United States
  • Edgewater, United States
  • Hialeah, United States
  • Jacksonville, United States
  • Leesburg, United States
  • Miami, United States
  • Miami Beach, United States
  • Miami Lakes, United States
  • Orange City, United States
  • Orlando, United States
  • Pembroke Pines, United States
  • Plantation, United States
  • Port Charlotte, United States
  • Saint Cloud, United States
  • Tampa, United States
  • Vero Beach, United States
  • Atlanta, United States
  • Dunwoody, United States
  • East Point, United States
  • Smyrna, United States
  • Suwanee, United States
  • Honolulu, United States
  • Chicago, United States
  • Gurnee, United States
  • Libertyville, United States
  • Skokie, United States
  • Brownsburg, United States
  • Manhattan, United States
  • Topeka, United States
  • Wichita, United States
  • Elizabethtown, United States
  • Lexington, United States
  • Paducah, United States
  • Mandeville, United States
  • Metairie, United States
  • Baltimore, United States
  • Boston, United States
  • Fall River, United States
  • Bloomfield Hills, United States
  • Detroit, United States
  • Kalamazoo, United States
  • Flowood, United States
  • Hazelwood, United States
  • Saint Charles, United States
  • St Louis, United States
  • Washington, United States
  • Lincoln, United States
  • Las Vegas, United States
  • Cherry Hill, United States
  • Albuquerque, United States
  • Brooklyn, United States
  • Cedarhurst, United States
  • Fresh Meadows, United States
  • New York, United States
  • Rochester, United States
  • Staten Island, United States
  • Charlotte, United States
  • Columbiana, United States
  • Durham, United States
  • Greensboro, United States
  • Raleigh, United States
  • Salisbury, United States
  • Wilmington, United States
  • Fargo, United States
  • Cincinnati, United States
  • Cleveland, United States
  • Dayton, United States
  • Franklin, United States
  • Oklahoma City, United States
  • Portland, United States
  • Allentown, United States
  • Duncansville, United States
  • Harleysville, United States
  • McMurray, United States
  • Media, United States
  • Philadelphia, United States
  • Pittsburgh, United States
  • Columbia, United States
  • Greer, United States
  • Old Point Station, United States
  • Clarksville, United States
  • Knoxville, United States
  • Memphis, United States
  • Austin, United States
  • Bellaire, United States
  • Corpus Christi, United States
  • Dallas, United States
  • Irving, United States
  • Nassau Bay, United States
  • Plano, United States
  • San Antonio, United States
  • Bountiful, United States
  • Newport News, United States
  • Norfolk, United States
  • Richmond, United States
  • Virginia Beach, United States
  • Kirkland, United States
  • Richland, United States
  • Seattle, United States
  • Clarksburg, United States
  • Milwaukee, United States
  • Buenos Aires, Argentina
  • Córdoba, Argentina
  • Mendoza, Argentina
  • Santa Fe, Argentina
  • Antofagasta, Chile
  • Arauco, Chile
  • Elqui, Chile
  • Santiago, Chile
  • Bello, Colombia
  • Antioquia, Colombia
  • Barranquilla, Colombia
  • Bogotá, Colombia
  • Mexicali, Mexico
  • León, Mexico
  • Mexico City, Mexico
  • Monterrey, Mexico
  • Mérida, Mexico
  • México, Mexico

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FAQ

Questions about this study

Who is behind this study?

The study sponsor is Takeda.

Does this study involve medication?

Yes. The study involves medication, including Ramelteon SL 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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