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COMPLETED
NCT00706654
PHASE3

Intramuscular Depot Formulation of Aripiprazole as Maintenance Treatment in Patients With Schizophrenia

Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

View on ClinicalTrials.gov

Summary

The purpose of the this trial is to evaluate the efficacy, safety, and tolerability of an intramuscular (IM) depot formulation of aripiprazole as maintenance treatment in patients with schizophrenia The trial is designed into three treatment phases. Phase 1 is designed to allow for a subject to be converted from the current anti-psychotic treatment to oral non-generic aripiprazole monotherapy (oral conversion phase from 4 to 6 weeks). During Phase 2 the subject will be stabilized on oral non-generic aripiprazole monotherapy. Once the subject is stabilized in Phase 2 (oral stabilization phase from minimum 8 weeks to maximum 28 weeks), they are eligible to be randomized into the double-blind IM depot maintenance phase, Phase 3. During Phase 3, the subject will be assessed for exacerbation of psychotic symptoms and impending relapse for up to 38 weeks.

Official title: A 38-week, Multicenter, Randomized, Double-blind, Active-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of an Intramuscular Depot Formulation of Aripiprazole (OPC-14597) as Maintenance Treatment in Patients With Schizophrenia

Key Details

Gender

All

Age Range

18 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

937

Start Date

2008-09-01

Completion Date

2012-08-01

Last Updated

2026-06-04

Healthy Volunteers

No

Conditions

Interventions

DRUG

Aripiprazole depot 300 or 400 mg

Aripiprazole depot was supplied in 400 mg lyophilized vials. Patients received aripiprazole 300 mg if they were unable to tolerate aripiprazole 400 mg.

DRUG

Aripiprazole 10-30 mg orally

Aripiprazole was supplied as 10, 15, and 20 mg tablets. The dose that the patient received was based on the investigator's judgment and the subject's clinical need.

DRUG

Aripiprazole depot 25 or 50 mg

Aripiprazole depot was supplied in 200 mg lyophilized vials. Patients received aripiprazole 25 mg if they were unable to tolerate aripiprazole 50 mg.

DRUG

Placebo depot

Placebo depot was supplied in lyophilized vials.

DRUG

Placebo tablets

Placebo tablets were identical in appearance to the aripiprazole tablets.

Locations (98)

Cerritos, California, United States

Escondido, California, United States

Garden Grove, California, United States

Oceanside, California, United States

Orange, California, United States

Orange, California, United States

Pasadena, California, United States

Pico Rivera, California, United States

San Diego, California, United States

San Diego, California, United States

San Diego, California, United States

Torrance, California, United States

Washington D.C., District of Columbia, United States

Gainesville, Florida, United States

Kissimmee, Florida, United States

Plantation, Florida, United States

Tampa, Florida, United States

Chicago, Illinois, United States

Oak Brook, Illinois, United States

Shreveport, Louisiana, United States

Towson, Maryland, United States

Kansas City, Missouri, United States

Buffalo, New York, United States

New York, New York, United States

New York, New York, United States

Rochester, New York, United States

Hickory, North Carolina, United States

South Carolina, North Carolina, United States

Garfield Heights, Ohio, United States

Toledo, Ohio, United States

Oklahoma City, Oklahoma, United States

Charleston, South Carolina, United States

Charleston, South Carolina, United States

Johnson City, Tennessee, United States

Nashville, Tennessee, United States

Arlington, Texas, United States

Austin, Texas, United States

Richmond, Virginia, United States

Milwaukee, Wisconsin, United States

Innsbruck, Austria

Bruges, Belgium

Burgas, Bulgaria

Pazardzhik, Bulgaria

Pleven, Bulgaria

Plovdiv, Bulgaria

Sofia, Bulgaria

Sofia, Bulgaria

Sofia, Bulgaria

Varna, Bulgaria

Santiago, Chile

Santiago, Chile

Santiago, Chile

Santiago, Chile

Santiago, Chile

Santiago, Chile

Temuco, Chile

Valdivia, Chile

Zagreb, Croatia

Zagreb, Croatia

Jämejala, Viljandimaa, Estonia

Meegomäe, Estonia

Tallinn, Estonia

Tallinn, Estonia

Tartu, Estonia

Tartu, Estonia

Bully-les-Mines, France

Élancourt, France

Rennes, France

Saint-Nazaire, France

Baja, Hungary

Balassagyarmat, Hungary

Cegléd, Hungary

Győőor, Hungary

Milan, Italy

Milan, Italy

Pisa, Italy

Bełchatów, Poland

Bialystok, Poland

Bydgoszcz, Poland

Choroszcz, Poland

Krakow, Poland

Leszno, Poland

Pruszków, Poland

Sosnowiec, Poland

Wroclaw, Poland

San Juan, Puerto Rico

Pretoria, Gauteng, South Africa

Cape Town, Western Province, South Africa

Busan, South Korea

Daejeon, South Korea

Gwangju, South Korea

Incheon, South Korea

Seoul, South Korea

Seoul, South Korea

Seoul, South Korea

Muang, Chiangmai, Thailand

Muang, Chiangmai, Thailand

Bangkok, Thailand