NCT02453893

Brief Summary

This research is a Randomized, double-blind, risperidone-controlled, multicenter clinical study. Chinese subjects with Ischemic Schizophrenia.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
288

participants targeted

Target at P50-P75 for phase_3 schizophrenia

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2013

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

May 19, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 27, 2015

Completed
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Last Updated

May 27, 2015

Status Verified

March 1, 2015

Enrollment Period

1.6 years

First QC Date

May 19, 2015

Last Update Submit

May 26, 2015

Conditions

Schizophrenia

Keywords

IloperidoneRisperidonePANSS

Outcome Measures

Primary Outcomes (1)

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

    8 weeks

Secondary Outcomes (2)

  • 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

Study Arms (2)

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

IloperidoneDRUG
oral iloperidone
RisperidoneDRUG
oral risperidone

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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。

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, 200030, China

RECRUITING

MeSH Terms

Conditions

Schizophrenia

Interventions

iloperidoneRisperidone

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Li hua fang, Ph.D

    Shanghai Mental Health Center

    STUDY DIRECTOR

Central Study Contacts

Wang yu mei, master

CONTACT

86-311-67808816

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 19, 2015

First Posted

May 27, 2015

Study Start

November 1, 2013

Primary Completion

June 1, 2015

Last Updated

May 27, 2015

Record last verified: 2015-03

Locations

CN(1)