Risperidone-controlled,Multicentre Clinical Trial of Ilop... | NCT02453893

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

NCT02453893

Sponsor

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Status

Unknown status

Last Update Posted

May 27, 2015Estimated

Enrollment

288Estimated

Phase

Phase 3

Conditions

Schizophrenia

Interventions

Iloperidone
Risperidone

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2013

Primary Completion Date

Jun 2015Estimated

Completion Date

Not provided

First Submitted Date

May 19, 2015

First Submission Date that Met QC Criteria

May 26, 2015

First Posted Date

May 27, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 26, 2015

Last Update Posted Date

May 27, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

288Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
oral iloperidone	Experimental	2~12mg/day for 2 weeks,12~24mg/day for 6 weeks.	Drug: Iloperidone
oral risperidone	Active Comparator	1~3mg/day for 2 weeks,3~6mg/day for 6 weeks.	Drug: Risperidone

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Iloperidone	Drug		oral iloperidone
Risperidone

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
the score of Positive and Negative syndrome scale to evaluation the severity of schizophrenia		8 weeks

Secondary Outcomes

Measure	Description	Time Frame
the score of clinical global impressions to evaluation the severity of illness		8 weeks
the score of clinical global impressions to evaluation the improvement of illness		8 weeks

Other Outcomes

Not provided

Eligibility Module

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。

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Wang yu mei, master	Contact	86-311-67808816

Overall Officials

Name	Affiliation	Role
Li hua fang, Ph.D	Shanghai Mental Health Center	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Shanghai Mental Health Center	Recruiting	Shanghai	Shanghai Municipality	200030	China

Condition Browse Module

MeSH Terms

ID	Term
D012559	Schizophrenia

Ancestor Terms

ID	Term
D019967	Schizophrenia Spectrum and Other Psychotic Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C081732	iloperidone
D018967	Risperidone

Ancestor Terms

ID	Term
D011744	Pyrimidinones
D011743	Pyrimidines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided