A Clinical Trial of Lurasidone in Treatment of Schizophrenia

Schizophrenia Clinical Trial

Official title:

A Randomized, Double-blind, Double-dummy, Parallel-group and Multicenter Study to Investigate Lurasidone in Treatment of Schizophrenia Compared With Risperidone

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02002832
• Other study ID #: D1070004
• Status: Completed
• Phase: Phase 3
• Start date: December 2013
• Est. completion date: November 2015

Study information

• Verified date: May 2018
• Source: Sumitomo Pharmaceutical (Suzhou) Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 388
• Est. completion date: November 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• Lurasidone tablets
Lurasidone tablets (40or80mg/day) and Risperidone tablets(Placebo)
• Risperidone tablets
Risperidone tablets(2-6mg/day) and Lurasidone tablets(Placebo)

Locations

Country	Name	City	State
China	HeBei Mental Health Center	Baoding	Hebei
China	Beijing Huilongguan Hospital	Beijing	Beijing
China	Capital Medical University Affiliated Beijing Anding Hospital	Beijing	Beijing
China	Peking University Sixth Hospital	Beijing	Beijing
China	Hunan Province Brain Hospital	Changsha	Hunan
China	The Second Xiangya Hospital of Central South University	Changsha	Hunan
China	West China Hospital, Sichuan University	Chengdu	Sichuan
China	Guangzhou Brain Hospital	Guangzhou	Guangdong
China	First Affiliated Hospital of Kunming Medical University	Kunming	Yunnan
China	Nanjing Brain Hospital	Nanjing	Jiangsu
China	Shanghai Mental Health Center	Shanghai	Shanghai
China	Tianjin Anding Hospital	Tianjin	Tianjin
China	Wuxi Mental Health Center	Wuxi	Jiangsu
China	Xi'an Mental Health Center	Xi'an	Shanxi
China	Henan Provincial Mental Hospital	Xinxiang	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Sumitomo Pharmaceutical (Suzhou) Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Change From Baseline to Week 6 in Positive and Negative Syndrome Scale (PANSS) Total Scores.	Mean change in Positive and Negative Syndrome Scale total score from baseline to Week 6 at the end of treatment. PANSS is an interview-based measure of the severity of psychopathology in adults with psychotic disorders. It have 30 evaluation items, which include 7 positive sub-scale, 7 negative sub-scale and 16 general psychopathology sub-scale on a score of 1 to 7. The total score is the sum of the 30 scale items. The minimum score is 30 and the maximum score is 210. Patient with PANSS total scores<70 is the normal,but the scores>120 is more serious.	From baseline to Week 6(day 42).
Secondary	Mean Clinical Global Impression Scale-Improvement (CGI-I) Score at Week 6.	The Clinical Global Impression Scale-Improvement (CGI-I) Score is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to baseline state at the beginning of the intervention. Response is rated as one of the following, in which higher scores indicate less improvement or worsening: 1=Very much improved, 2=Much improved, 3=Minimally improved, 4=No change, 5=Minimally worse, 6=Much worse, and 7=Very much worse.	From baseline to Week 6(day 42).