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A Clinical Trial of Lurasidone in Treatment of Schizophrenia

Sumitomo Pharma logo

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

388 participants in 2 patient groups

Lurasidone group
Experimental group
Treatment:
Drug: Lurasidone tablets
Risperidone group
Active Comparator group
Treatment:
Drug: Risperidone tablets

Trial contacts and locations

15

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Data sourced from clinicaltrials.gov

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