Efficacy, Safety, and Tolerability of Brexpiprazole (OPC-34712) as Maintenance Treatment in Adults With Schizophrenia

Completed · Phase 3 · Has a placebo group

Conditions studied: Acute Schizophrenia

In brief

The purpose of this study is to evaluate the efficacy of brexpiprazole compared with placebo as maintenance treatment in adults with schizophrenia.

Key facts

Study ID

NCT01668797

Run by

Otsuka Pharmaceutical Development & Commercialization, Inc.

People needed

524

Starts

2012-10-01

Expected to finish

2015-02-01

Last updated by the study team

2017-01-13

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients age 18 years or older to less than 65 years, inclusive (at time of informed consent)
• Subjects with a current diagnosis of schizophrenia, as defined by DSM-IV-TR criteria and a history of the illness for at least three years prior to screening (as per subject, family, healthcare provider, or by previous medical records).
• Subjects with a stable living environment, as demonstrated by the ability to provide contact information for themselves and/or family/friend(s)/caregiver(s).
• Subjects who showed previous response to antipsychotic treatment in the past year.
• Subjects who are currently treated with oral or depot antipsychotics other than clozapine or who have had a recent lapse in antipsychotic treatment requiring chronic treatment with antipsychotic medication for stabilization.
• Subjects who are experiencing a current acute exacerbation of psychotic symptoms requiring stabilization
• Subjects with a history of relapse and/or exacerbation of symptoms when they are not receiving antipsychotic treatment.

You may not qualify if…

• Female patients who are breastfeeding or who have a positive pregnancy test (urine) result prior to receiving investigational medicinal product
• Patients presenting a first episode of schizophrenia based on the clinical judgment of the investigator
• Patients who are diagnosed with a disease other than schizophrenia (schizoaffective disorder, major depressive disorder, bipolar disorder, posttraumatic stress disorder, anxiety disorder, delirium, dementia, amnesia, or other cognitive disorder) based on current DSM-IV-TR Axis Ι criteria, or who are diagnosed with a personality disorder (borderline, paranoid, histrionic, schizotypal, schizoid, or antisocial)
• Subjects experiencing acute depressive symptoms within the past 30 days
• Subjects with schizophrenia who are considered resistant/refractory to antipsychotic treatment by history
• Subjects with a significant risk of violent behavior; who represent a risk of committing suicide
• Subjects with clinically significant tardive dyskinesia
• Subjects currently treated with insulin for diabetes.

Where it is running

• Study site — Anaheim, California, United States
• Study site — Cerritos, California, United States
• Study site — Garden Grove, California, United States
• Study site — San Diego, California, United States
• Study site — San Diego, California, United States
• Study site — Tampa, Florida, United States
• Study site — Hoffman Estates, Illinois, United States
• Study site — Saint Charles, Missouri, United States
• Study site — St Louis, Missouri, United States
• Study site — North Platte, Nebraska, United States
• Study site — Las Vegas, Nevada, United States
• Study site — Memphis, Tennessee, United States
• Study site — Dallas, Texas, United States
• Study site — Richmond, Virginia, United States
• Study site — Barranquilla, Colombia
• Study site — Bello, Colombia
• Study site — Bogotá, Colombia
• Study site — Pereira, Colombia
• Study site — Kota Bharu, Kelantan, Malaysia
• Study site — Kuala Lumpur, Kuala Lumpur, Malaysia
• Study site — Kuala Lumpur, Kuala Lumpur, Malaysia
• Study site — Kajang, Selangor, Malaysia
• Study site — Sabak Bernam, Malaysia
• Study site — San Juan, Puerto Rico
• Study site — San Juan, Puerto Rico

Full record on ClinicalTrials.gov

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