A Long-term Trial of OPC-34712 in Patients With Schizophrenia

Otsuka Pharmaceutical Co., Ltd.0 sites282 target enrollmentOctober 2011

InterventionsOPC-34712

Overview

To investigate the safety and efficacy of long-term administration of OPC-34712 in patients with schizophrenia.

Registry

clinicaltrials.gov

Start Date

October 2011

End Date

May 2015

Last Updated

6 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Sponsor

Responsible Party

Sponsor

•Patients age 18 years or older (at time of informed consent) diagnosed with schizophrenia based on DSM-IV-TR diagnostic criteria
•Outpatients who are receiving an oral antipsychotic treatment (other than clozapine), who are considered to require maintenance therapy using antipsychotics, and for whom monotherapy with OPC-34712 is considered feasible

•Female patients who are breastfeeding or who have a positive pregnancy test (urine) result prior to receiving investigational medicinal product
•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)

Intervention: OPC-34712

Percentage of Participants With Adverse Events

Time Frame: From Baseline up to 52 Weeks

A treatment-emergent adverse event (TEAE) is defined as an AE that started after start of investigational medicinal product (IMP) treatment.

Mean Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score(From Baseline up to 52 Weeks including Week24, Week52, and Last Visit(LOCF))
Mean Change From Baseline in PANSS Positive Subscale Score(From Baseline up to 52 Weeks including Week24, Week52, and Last Visit(LOCF))
Mean Change From Baseline in PANSS Negative Subscale Score(From Baseline up to 52 Weeks including Week24, Week52, and Last Visit(LOCF))
Mean Change From Baseline in Clinical Global Impression-Severity of Illness (CGI-S)(From Baseline up to 52 Weeks including Week24, Week52, and Last Visit(LOCF))
Mean Clinical Global Impression - Global Improvement(CGI-I)(From Baseline up to 52 Weeks including Week24, Week52, and Last Visit(LOCF))