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

NCT01456897 | Completed Phase 3 Results

• 2 other identifiers: 331-10-003JapicCTI-111632
• Study Type: interventional
• Target: 282
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Adverse Events

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

  From Baseline up to 52 Weeks

Secondary Outcomes (5)

• 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)

Study Arms (1)

OPC-34712

EXPERIMENTAL

Drug: OPC-34712

Interventions

OPC-34712 DRUG

orally administered once daily

OPC-34712

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

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 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)

Sponsors & Collaborators

• Otsuka Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Unknown Facility

Kanto Region, Japan

Location

Related Publications (1)

• Ishigooka J, Usami T, Iwashita S, Kojima Y, Matsuo S. Post-hoc analysis investigating the safety and efficacy of brexpiprazole in Japanese patients with schizophrenia who were switched from other antipsychotics in a long-term study (Secondary Publication). Neuropsychopharmacol Rep. 2020 Jun;40(2):122-129. doi: 10.1002/npr2.12107. Epub 2020 Apr 15.

  PMID: 32297486 DERIVED

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Results Point of Contact

• Title: Director of Clinical Trials
• Organization: Otsuka Pharmaceutical Co., Ltd.

CL_OPCJ_RDA_Team@otsuka.jp

Study Officials

• Kyoji Imaoka, Operating Officer

  Otsuka Pharmaceutical Co., Ltd.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2011
• First Posted: October 21, 2011
• Study Start: October 1, 2011
• Primary Completion: May 1, 2015
• Last Updated: December 30, 2019
• Results First Posted: December 30, 2019

Record last verified: 2016-10

Locations

JP (1)