A Clinical Trial of Lurasidone in Treatment of Schizophrenia

• Status: Completed
• Trial end date: 2015-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sumitomo Pharmaceutical (Suzhou) Co., Ltd.
• Treatments: Lurasidone Hydrochloride; Risperidone

Criteria

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.