Clinical trial NCT02002832: A Clinical Trial of Lurasidone in Treatment of Schizophrenia
Official title: A Randomized, Double-blind, Double-dummy, Parallel-group and Multicenter Study to Investigate Lurasidone in Treatment of Schizophrenia Compared With Risperidone
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Schizophrenia
Keywords: schizophrenia
Lurasidone
LATUDA
Lead sponsor: Sumitomo Pharma (Suzhou) Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2013-12-06
Enrollment: 388
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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.

Primary outcomes:
measure: Mean Change From Baseline to Week 6 in Positive and Negative Syndrome Scale (PANSS) Total Scores.
timeFrame: From baseline to Week 6(day 42).
Secondary outcomes:
measure: Mean Clinical Global Impression Scale-Improvement (CGI-I) Score at Week 6.
timeFrame: From baseline to Week 6(day 42).
Other outcomes:
Locations:
city: Beijing
country: China
facility: Capital Medical University Affiliated Beijing Anding Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Huilongguan Hospital
state: Beijing
city: Beijing
country: China
facility: Peking University Sixth Hospital
state: Beijing
city: Guangzhou
country: China
facility: Guangzhou Brain Hospital
state: Guangdong
city: Baoding
country: China
facility: HeBei Mental Health Center
state: Hebei
city: Xinxiang
country: China
facility: Henan Provincial Mental Hospital
state: Henan
city: Changsha
country: China
facility: The Second Xiangya Hospital of Central South University
state: Hunan
city: Changsha
country: China
facility: Hunan Province Brain Hospital
state: Hunan
city: Nanjing
country: China
facility: Nanjing Brain Hospital
state: Jiangsu
city: Wuxi
country: China
facility: Wuxi Mental Health Center
state: Jiangsu
city: Shanghai
country: China
facility: Shanghai Mental Health Center
state: Shanghai
city: Xi'an
country: China
facility: Xi'an Mental Health Center
state: Shanxi
city: Chengdu
country: China
facility: West China Hospital, Sichuan University
state: Sichuan
city: Tianjin
country: China
facility: Tianjin Anding Hospital
state: Tianjin
city: Kunming
country: China
facility: First Affiliated Hospital of Kunming Medical University
state: Yunnan
Study officials:
affiliation: Capital Medical University Affiliated Beijing Anding Hospital
name: Zhuoji CAI, MD
role: PRINCIPAL_INVESTIGATOR
References: