Safety and Efficacy Study of Ramelteon (TAK-375) Tablets for Sublingual Administration (SL) in Adults With Bipolar 1 Disorder

PHASE3TerminatedINTERVENTIONAL
Enrollment

535

Participants

Timeline

Start Date

August 31, 2012

Primary Completion Date

August 31, 2014

Study Completion Date

September 30, 2014

Conditions
Bipolar Disorder
Interventions
DRUG

Ramelteon

Ramelteon tablets for sublingual administration

DRUG

Placebo

Ramelteon placebo-matching tablets for sublingual administration

Trial Locations (104)

Unknown

Birmingham

Anaheim

Glendale

Imperial

Los Angeles

Oakland

Oceanside

Pico Rivera

San Diego

Stanford

Hartford

Coral Springs

Deerfield Beach

Gainesville

Jacksonville

Maitland

Oakland Park

Orlando

Tampa

West Palm Beach

Chicago

Joliet

Naperville

Oak Brook

Lafayette

Boston

St Louis

Buffalo

New York

Staten Island

The Bronx

Avon Lake

Cincinnati

Garfield Heights

Mason

Oklahoma City

Memphis

San Antonio

Bothell

Spokane

Waukesha

Burgas

Kazanlak

Lovech

Novi Iskar

Pleven

Plovdiv

Rousse

Sofia

Tzerova Koria

Varna

Brno

Litoměřice

Olomouc

Pilsen

Prague

Bochum

Berlin

Berlin

Westerstede

Bialystok

Choroszcz

Oradea

Cluj-Napoca

Craiova

Târgovişte

Bucharest

Arad

Bucharest

Cluj-Napoca

Craiova

Iași

Târgovişte

Talagi

Orenburg

Staritsa Settlement

Saint Petersburg

Town. Tonnelniy

Arkhangelsk

Moscow

Nizhny Novgorod

Saint Petersburg

Smolensk

Stavropol

Belgrade

Kragujevac

Novi Sad

Belgrade

Kragujevac

Niš

Novi Kneževac

Simferopol

Oleksandrivka, Kominternivske District

Simferopol

Vinnytsia

Kharkiv

Luhansk

Odesa

Poltava

Ternopil

Oxford

Birmingham

London

Newcastle upon Tyne

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Takeda

INDUSTRY