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Lurasidone HCl: A Phase 3 Study of Patients With Acute Schizophrenia | Clinical Trials | Clareo Health

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Lurasidone HCl: A Phase 3 Study of Patients With Acute Schizophrenia

A Phase 3 Randomized, Placebo-Controlled, CLinical Trial to Study the Safety and Efficacy of Three Doses of Lurasidone HCl in Acutely Psychotic Patients With Schizophrenia

NCT00549718•Sumitomo Pharma America, Inc.

View on ClinicalTrials.gov

Summary

Lurasidone HCl is a compound being developed for the treatment of schizophrenia. This clinical study is designed to test the hypothesis that lurasidone is more efficacious than placebo. The study will also evaluate the safety and tolerability of lurasidone as compared to placebo.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Provide written informed consent and aged between 18 and 75 years of age.
•Meets DSM-IV™ criteria for a primary diagnosis of schizophrenia.
•Not pregnant, if of reproductive potential agrees to remain abstinent or use adequate and reliable contraception for duration of study.
•Able and agrees to remain off prior antipsychotic medication for the duration of study.
•Good physical health on the basis of medical history, physical examination, and laboratory screening.
•Willing and able to comply with the protocol, including the inpatient requirements and outpatient visits.

Exclusion Criteria

•Considered by the investigator to be at imminent risk of suicide or injury to self, others, or property.
•Any chronic organic disease of the CNS (other than schizophrenia)
•Used investigational compound within 30 days.
•Clinically significant or history of alcohol abuse/alcoholism or drug abuse/dependence within the last 6 months.

Locations (48)

K&S Professional Research Services, LLC.

Little Rock, Arkansas, United States

Comprehensive Neuroscience, Inc

Cerritos, California, United States

Clinical Innovations, Inc.

Costa Mesa, California, United States

Collaborative Neuroscience Network Inc.,12772 Valley View Street,Suite 3

Garden Grove, California, United States

California Clinical Trials

Paramount, California, United States

Pasadena Research Institute

Pasadena, California, United States

California Neuropsychopharmacology,CNRI - Los Angeles LLC,8309 Telegraph Road

Pico Rivera, California, United States

Sharp Mesa Vista Hospital

San Diego, California, United States

Comprehensive Neuroscience, Inc.

Washington D.C., District of Columbia, United States

Florida Clinical Research Center, LLC

Bradenton, Florida, United States

Key Dates

Start Date

October 1, 2007

Primary Completion Date

October 1, 2010

Completion Date

October 1, 2010

Last Updated

June 11, 2014

Enrollment

489

ACTUAL participants

Conditions

Schizophrenia

Interventions

Lurasidone HCl

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

View study

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: June 11, 2014Data 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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Lurasidone HCl: A Phase 3 Study of Patients With Acute Schizophrenia

Inclusion Criteria

Exclusion Criteria

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

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