A Clinical Trial of Lurasidone in Treatment of Schizophrenia

Sumitomo Pharma

Status and phase

Completed

Phase 3

Conditions

Schizophrenia

Treatments

Drug: Lurasidone tablets

Drug: Risperidone tablets

Study type

Interventional

Funder types

Industry

Identifiers

NCT02002832

D1070004

Details and patient eligibility

About

This is a randomized, double-blind, double-dummy, parallel- controlled, adjustable dose, non-inferiority and multicentre study designed to evaluate the efficacy and safety of lurasidone on schizophrenia for 6 weeks treatment, and to compare with risperidone.

Enrollment

388 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Provide written informed consent and aged between 18 and 65 years of age.
Meets DSM-IV-TR criteria for a primary diagnosis of schizophrenia, had a PANSS total score ≥ 70 and ≤ 120 at Screening and Baseline, and a score ≥ 4 on the CGI-S at Screening and Baseline.
Not pregnant, if of reproductive potential agrees to use adequate and reliable contraception for duration of study.
Able and agrees to remain off prior antipsychotic medication for the duration of study.
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)
Subjects are participating or participated in other clinical studies including marketed drugs or medical devices within 30 days before signing the informed consent form.
Clinically significant or history of alcohol abuse/alcoholism or drug abuse/dependence within the last 6 months.