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

• Status: Completed
• Trial end date: 2015-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
• Collaborator: Quintiles, Inc.
• Treatments: Brexpiprazole

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.