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

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

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02453893
Enrollment
288
Registered
2015-05-27
Start date
2013-11-30
Completion date
Unknown
Last updated
2015-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia

Keywords

Iloperidone, Risperidone, PANSS

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.

Interventions

DRUGRisperidone

Sponsors

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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。

Design outcomes

Primary

MeasureTime frame
the score of Positive and Negative syndrome scale to evaluation the severity of schizophrenia8 weeks

Secondary

MeasureTime frame
the score of clinical global impressions to evaluation the severity of illness8 weeks
the score of clinical global impressions to evaluation the improvement of illness8 weeks

Countries

China

Contacts

Primary ContactWang yu mei, master
86-311-67808816

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026