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Intramuscular Depot Formulation of Aripiprazole as Maintenance Treatment in Patients With Schizophrenia
Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
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
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.
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.
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.
Placebo depot
Placebo depot was supplied in lyophilized vials.
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