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A Clinical Trial of Lurasidone in Treatment of Schizophrenia

Primary Purpose

Schizophrenia

Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Lurasidone tablets
Risperidone tablets
Sponsored by
Sumitomo Pharma (Suzhou) Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring schizophrenia, Lurasidone, LATUDA

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Capital Medical University Affiliated Beijing Anding Hospital
  • Beijing Huilongguan Hospital
  • Peking University Sixth Hospital
  • Guangzhou Brain Hospital
  • HeBei Mental Health Center
  • Henan Provincial Mental Hospital
  • The Second Xiangya Hospital of Central South University
  • Hunan Province Brain Hospital
  • Nanjing Brain Hospital
  • Wuxi Mental Health Center
  • Shanghai Mental Health Center
  • Xi'an Mental Health Center
  • West China Hospital, Sichuan University
  • Tianjin Anding Hospital
  • First Affiliated Hospital of Kunming Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Lurasidone group

Risperidone group

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
December 2, 2013
Last Updated
November 3, 2019
Sponsor
Sumitomo Pharma (Suzhou) Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02002832
Brief Title
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

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
December 2013 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
November 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sumitomo Pharma (Suzhou) Co., Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
schizophrenia, Lurasidone, LATUDA

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
388 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lurasidone group
Arm Type
Experimental
Arm Title
Risperidone group
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Lurasidone tablets
Other Intervention Name(s)
LATUDA
Intervention Description
Lurasidone tablets (40or80mg/day) and Risperidone tablets(Placebo)
Intervention Type
Drug
Intervention Name(s)
Risperidone tablets
Intervention Description
Risperidone tablets(2-6mg/day) and Lurasidone tablets(Placebo)
Primary Outcome Measure Information:
Title
Mean Change From Baseline to Week 6 in Positive and Negative Syndrome Scale (PANSS) Total Scores.
Description
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.
Time Frame
From baseline to Week 6(day 42).
Secondary Outcome Measure Information:
Title
Mean Clinical Global Impression Scale-Improvement (CGI-I) Score at Week 6.
Description
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.
Time Frame
From baseline to Week 6(day 42).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhuoji CAI, MD
Organizational Affiliation
Capital Medical University Affiliated Beijing Anding Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Capital Medical University Affiliated Beijing Anding Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100088
Country
China
Facility Name
Beijing Huilongguan Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100096
Country
China
Facility Name
Peking University Sixth Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100191
Country
China
Facility Name
Guangzhou Brain Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510370
Country
China
Facility Name
HeBei Mental Health Center
City
Baoding
State/Province
Hebei
ZIP/Postal Code
071000
Country
China
Facility Name
Henan Provincial Mental Hospital
City
Xinxiang
State/Province
Henan
ZIP/Postal Code
453002
Country
China
Facility Name
The Second Xiangya Hospital of Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410000
Country
China
Facility Name
Hunan Province Brain Hospital
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410007
Country
China
Facility Name
Nanjing Brain Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210029
Country
China
Facility Name
Wuxi Mental Health Center
City
Wuxi
State/Province
Jiangsu
ZIP/Postal Code
214000
Country
China
Facility Name
Shanghai Mental Health Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200030
Country
China
Facility Name
Xi'an Mental Health Center
City
Xi'an
State/Province
Shanxi
ZIP/Postal Code
710061
Country
China
Facility Name
West China Hospital, Sichuan University
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Facility Name
Tianjin Anding Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300222
Country
China
Facility Name
First Affiliated Hospital of Kunming Medical University
City
Kunming
State/Province
Yunnan
ZIP/Postal Code
650032
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

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A Clinical Trial of Lurasidone in Treatment of Schizophrenia

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