Efficacy, Safety, and Tolerability of an Intramuscular Formulation of Aripiprazole (OPC-14597) as Maintenance Treatment in Bipolar I Patients

PHASE3CompletedINTERVENTIONAL
Enrollment

731

Participants

Timeline

Start Date

August 31, 2012

Primary Completion Date

April 30, 2016

Study Completion Date

April 30, 2016

Conditions
Bipolar I Disorder
Interventions
DRUG

Intramuscular (IM) Depot Aripiprazole

Formulation: Intramuscular (IM) Depot Aripiprazole Formulation 400 mg or 300 mg, once a month injection

DRUG

Intramuscular (IM) Depot Placebo

Formulation: Intramuscular (IM) Depot Placebo 400 mg or 300 mg, once a month injection

Trial Locations (76)

Unknown

Birmingham

Springdale

Beverly Hills

Costa Mesa

Escondido

Garden Grove

Los Angeles

National City

Oceanside

Orange

Pico Rivera

Riverside

San Diego

Temecula

Torrance

Lauderhill

Leesburg

Melbourne

Oakland Park

Atlanta

Decatur

Smyrna

Hoffman Estates

New Orleans

Rockville

Flowood

Saint Charles

St Louis

Lincoln

Cherry Hill

Brooklyn

Buffalo

New York

Cincinnati

Dayton

Oklahoma City

Allentown

Jenkintown

Austin

Dallas

Wichita Falls

Richmond

Chatham

Aizu-Wakamatsu

Sapporo

Morioka

Kawasaki-shi

Yokohama

Kashihara

Sakai

Sakai-shi

Fukuoka

Itabashi-bu

Kanzaki-gun

Koriyama-shi

Kumamoto

Okinawa

Shinjuku-ku

Tokyo

Tottori

Toyama

Gdynia

Bydgoszcz

Chełmno

Choroszcz

Târgovişte

Bucharest

Judet Lasi

Anyang-si

Goyang-si

Daejeon

Jeju City

Seoul

Keelung

Taipei

Taouyuan County

All Listed Sponsors
collaborator

H. Lundbeck A/S

INDUSTRY

lead

Otsuka Pharmaceutical Development & Commercialization, Inc.

INDUSTRY

NCT01567527 - Efficacy, Safety, and Tolerability of an Intramuscular Formulation of Aripiprazole (OPC-14597) as Maintenance Treatment in Bipolar I Patients | Biotech Hunter | Biotech Hunter