A Dose-finding Trial of OPC-34712 in Patients With Schizophrenia

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Otsuka Pharmaceutical Co., Ltd.

ClinicalTrials.gov Identifier:

NCT01451164

First received: October 11, 2011

Last updated: October 5, 2016

Last verified: October 2016

History of Changes

Purpose

To investigate the efficacy and safety of OPC-34712 in comparison with placebo in patients with schizophrenia.

Condition	Intervention	Phase
Schizophrenia	Drug: OPC-34712 Drug: Placebo	Phase 2 Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Dose-finding Trial of OPC-34712 in Patients With Schizophrenia

Resource links provided by NLM:

Genetics Home Reference related topics: schizophrenia

MedlinePlus related topics: Schizophrenia

U.S. FDA Resources

Further study details as provided by Otsuka Pharmaceutical Co., Ltd.:

Primary Outcome Measures:

Change in Positive and Negative Syndrome Scale(PANSS) Total Score from Baseline to Week6 [ Time Frame: Baseline, Week 6 ]

Secondary Outcome Measures:

Change in Clinical Global Impression - Severity of Illness (CGI-S) from Baseline to Week 6 [ Time Frame: Baseline, Week 6 ]


Enrollment:	458
Study Start Date:	October 2011
Primary Completion Date:	June 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: High dose	Drug: OPC-34712 orally administered once daily
Experimental: Mid dose	Drug: OPC-34712 orally administered once daily
Experimental: Low dose	Drug: OPC-34712 orally administered once daily
Placebo Comparator: Placebo	Drug: Placebo orally administered once daily

Eligibility


Ages Eligible for Study:	18 Years to 65 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients age 18 years or older to less than 65 years (at time of informed consent) diagnosed with schizophrenia based on DSM-IV-TR diagnostic criteria
Patients who are hospitalized, or judged to required hospitalization, for acute relapse of schizophrenia at time of informed consent
Patients who are experiencing acute exacerbation of psychotic symptoms

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)

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01451164

Locations


Japan

Kanto Region, Japan

Sponsors and Collaborators

Otsuka Pharmaceutical Co., Ltd.

Investigators


Study Director:	kyoji Imaoka, Operating Officer	Otsuka Pharmaceutical Co., Ltd.

More Information


Responsible Party:	Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:	NCT01451164 History of Changes
Other Study ID Numbers:	331-10-002 JapicCTI-111631 ( Other Identifier: JAPIC )
Study First Received:	October 11, 2011
Last Updated:	October 5, 2016

Additional relevant MeSH terms:


Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders Mental Disorders

ClinicalTrials.gov processed this record on July 24, 2017

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