Brexpiprazole (OPC-34712) Trial in the Treatment of Adults With Acute Schizophrenia

Otsuka

Status and phase

Completed

Phase 3

Conditions

Schizophrenia

Treatments

Drug: Brexpiprazole

Drug: Aripiprazole

Study type

Interventional

Funder types

Industry

Identifiers

NCT02054702

331-13-008

Details and patient eligibility

About

The purpose of this study is to explore changes in efficacy, cognitive functioning, and safety of flexibly-dosed Brexpiprazole monotherapy in subjects with acute schizophrenia

Enrollment

97 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

18 to 65 years of age, inclusive, at the time of informed consent with a diagnosis of schizophrenia as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) and confirmed by the Mini International Neuropsychiatric Interview (M.I.N.I) for Schizophrenia and Psychotic Disorders Studies
Would benefit from hospitalization or continued hospitalization for treatment of a current acute relapse of schizophrenia at trial entry
Are experiencing an acute exacerbation of psychotic symptoms and marked deterioration of usual function as demonstrated by all of the following:
Positive and Negative Syndrome Scale (PANSS) Total Score of ≥ 80
Score of ≥ 4 on two or more of the following PANSS items at screening: hallucinatory behavior, unusual thought content, conceptual disorganization, or suspiciousness
Clinical Global Impression - Severity of Illness Scale (CGI-S) score ≥ 4 (moderately ill)

Exclusion criteria

Are presenting with a first episode of schizophrenia based on the clinical judgment of the investigator
Have been hospitalized > 21 days for the current acute episode at the time of the baseline visit
Have a current DSM-IV-TR Axis I diagnosis other than schizophrenia, including, but not limited to, schizoaffective disorder, major depressive disorder (MDD), bipolar disorder, post-traumatic stress disorder, anxiety disorders, delirium, dementia, amnestic, or other cognitive disorders; also borderline, paranoid, histrionic, schizotypal, schizoid, antisocial personality disorders or mental retardation.
Improvement of ≥ 20% in total PANSS score between the screening and baseline assessments.