Efficacy and Safety of Ramelteon Sublingual in Adult Patients With Acute Depressive Episodes Associated With Bipolar I Disorder

PHASE3TerminatedINTERVENTIONAL
Enrollment

490

Participants

Timeline

Start Date

December 31, 2011

Primary Completion Date

March 31, 2015

Study Completion Date

March 31, 2015

Conditions
Acute Depressive Episode
Interventions
DRUG

Ramelteon SL

Ramelteon SL tablets

DRUG

Placebo

Ramelteon placebo-matching tablets

Trial Locations (161)

60610

Chicago

Gurnee

Unknown

Birmingham

Dothan

Muscle Shoals

Phoenix

Fayetteville

Little Rock

Bellflower

Costa Mesa

Garden Grove

Harbor City

Huntington Park

Irvine

Lomita

Long Beach

Los Angeles

Murrieta

National City

Oceanside

Orange

Paramount

Rancho Cucamonga

Redondo Beach

Riverside

Sacramento

San Diego

San Jose

San Ramon

Sherman Oaks

Torrance

Wildomar

Colorado Springs

Denver

Norwalk

Washington D.C.

Clearwater

Coral Gables

Coral Springs

Edgewater

Hialeah

Jacksonville

Leesburg

Miami

Miami Beach

Miami Lakes

Orange City

Orlando

Pembroke Pines

Plantation

Port Charlotte

Saint Cloud

Tampa

Vero Beach

Atlanta

Dunwoody

East Point

Smyrna

Suwanee

Honolulu

Chicago

Hoffman Estates

Libertyville

Skokie

Brownsburg

Manhattan

Topeka

Wichita

Elizabethtown

Lexington

Paducah

Mandeville

Metairie

Baltimore

Boston

Fall River

Bloomfield Hills

Detroit

Kalamazoo

Flowood

Hazelwood

Saint Charles

St Louis

Washington

Lincoln

Las Vegas

Cherry Hill

Albuquerque

Brooklyn

Cedarhurst

Fresh Meadows

New York

Rochester

Staten Island

Charlotte

Columbiana

Durham

Greensboro

Raleigh

Salisbury

Wilmington

Fargo

Cincinnati

Cleveland

Dayton

Franklin

Oklahoma City

Portland

Allentown

Duncansville

Harleysville

McMurray

Media

Philadelphia

Pittsburgh

Lincoln

Columbia

Greer

Old Point Station

Clarksville

Knoxville

Memphis

Austin

Bellaire

Corpus Christi

Dallas

Houston

Irving

Nassau Bay

Plano

San Antonio

Bountiful

Newport News

Norfolk

Richmond

Virginia Beach

Kirkland

Richland

Seattle

Clarksburg

Milwaukee

Buenos Aires

Córdoba

Mendoza

Santa Fe

Antofagasta

Arauco

Elqui

Santiago

Bello

Antioquia

Barranquilla

Bogotá

Mexicali

León

Mexico City

Monterrey

San Lucas

Mérida

México

San Luis Potosí City

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Takeda

INDUSTRY