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Risperidone-controlled,Multicentre Clinical Trial of Iloperidone in Patients With Schizophrenia

Primary Purpose

Schizophrenia

Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Iloperidone
Risperidone
Sponsored by
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Iloperidone, Risperidone, PANSS

Eligibility Criteria

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

Inclusion Criteria:

  • men and women aged 18 to 65 years with schizophrenia;
  • PANSS total score of at least 70 at screening and baseline;
  • at least 2 more than 4 points in 7 of PANSS-P;
  • informed consent.

Exclusion Criteria:

  • allergy with iloperidone or risperidone;
  • psychotic symptoms failing to improve after sufficient exposure to 2 antipsychotic treatment;
  • any other primary Axis 1 psychiatric diagnosis;
  • a history of alcohol or drug dependence in recent 1 year;
  • at imminent risk of harm to self or others;
  • systolic blood pressure≤90mmHg。

Sites / Locations

  • Shanghai Mental Health CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

oral iloperidone

oral risperidone

Arm Description

2~12mg/day for 2 weeks,12~24mg/day for 6 weeks.

1~3mg/day for 2 weeks,3~6mg/day for 6 weeks.

Outcomes

Primary Outcome Measures

the score of Positive and Negative syndrome scale to evaluation the severity of schizophrenia

Secondary Outcome Measures

the score of clinical global impressions to evaluation the severity of illness
the score of clinical global impressions to evaluation the improvement of illness

Full Information

First Posted
May 19, 2015
Last Updated
May 26, 2015
Sponsor
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02453893
Brief Title
Risperidone-controlled,Multicentre Clinical Trial of Iloperidone in Patients With Schizophrenia
Official Title
Double-blind,Double-simulation,Risperidone-controlled,Multicentre Clinical Trial of Iloperidone in Patients With Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Unknown status
Study Start Date
November 2013 (undefined)
Primary Completion Date
June 2015 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This research is a Randomized, double-blind, risperidone-controlled, multicenter clinical study. Chinese subjects with Ischemic Schizophrenia.
Detailed Description
Subjects will randomly enter into one of two groups,the period of treatment is 8 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Iloperidone, Risperidone, PANSS

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
288 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
oral iloperidone
Arm Type
Experimental
Arm Description
2~12mg/day for 2 weeks,12~24mg/day for 6 weeks.
Arm Title
oral risperidone
Arm Type
Active Comparator
Arm Description
1~3mg/day for 2 weeks,3~6mg/day for 6 weeks.
Intervention Type
Drug
Intervention Name(s)
Iloperidone
Intervention Type
Drug
Intervention Name(s)
Risperidone
Primary Outcome Measure Information:
Title
the score of Positive and Negative syndrome scale to evaluation the severity of schizophrenia
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
the score of clinical global impressions to evaluation the severity of illness
Time Frame
8 weeks
Title
the score of clinical global impressions to evaluation the improvement of illness
Time Frame
8 weeks

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: men and women aged 18 to 65 years with schizophrenia; PANSS total score of at least 70 at screening and baseline; at least 2 more than 4 points in 7 of PANSS-P; informed consent. Exclusion Criteria: allergy with iloperidone or risperidone; psychotic symptoms failing to improve after sufficient exposure to 2 antipsychotic treatment; any other primary Axis 1 psychiatric diagnosis; a history of alcohol or drug dependence in recent 1 year; at imminent risk of harm to self or others; systolic blood pressure≤90mmHg。
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wang yu mei, master
Phone
86-311-67808816
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Li hua fang, Ph.D
Organizational Affiliation
Shanghai Mental Health Center
Official's Role
Study Director
Facility Information:
Facility Name
Shanghai Mental Health Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200030
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Li Hua fang, Ph.D
Phone
86-021-34773128

12. IPD Sharing Statement

Learn more about this trial

Risperidone-controlled,Multicentre Clinical Trial of Iloperidone in Patients With Schizophrenia

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