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A Dose-finding Trial of OPC-34712 in Patients With Schizophrenia | Clinical Trials | Clareo Health

COMPLETEDPHASE2/PHASE3

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

NCT01451164•Otsuka Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

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)

Locations (1)

Kanto Region, Japan

Key Dates

Start Date

October 1, 2011

Primary Completion Date

June 1, 2015

Last Updated

October 3, 2019

Enrollment

459

ACTUAL participants

Conditions

Schizophrenia

Interventions

OPC-34712

DRUG

OPC-34712

DRUG

OPC-34712

DRUG

Placebo

DRUG

Feasibility, Acceptability, and Preliminary Efficacy of Yoga-based Group Intervention for Outpatients With Schizophrenia Spectrum Disorders

NCT07455929

Psychotic DisordersSchizophrenia Spectrum Disorders

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RECRUITING

Biomarkers/Biotypes, Course of Early Psychosis and Specialty Services

NCT06740383

Schizophrenia Spectrum and Other Psychotic DisordersSchizophrenia+5 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 3, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Feasibility, Acceptability, and Preliminary Efficacy of Yoga-based Group Intervention for Outpatients With Schizophrenia Spectrum Disorders

Biomarkers/Biotypes, Course of Early Psychosis and Specialty Services

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