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

CSPC Pharmaceutical Group

Status and phase: Unknown; Phase 3

Conditions: Schizophrenia

Treatments: Drug: Risperidone; Drug: Iloperidone

Study type: Interventional

Funder types: Industry

Identifiers

NCT02453893

CSPC-HC103/PRO/Ⅱ

Details and patient eligibility

About

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

Full description

Subjects will randomly enter into one of two groups,the period of treatment is 8 weeks.

Enrollment: 288 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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。

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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288 participants in 2 patient groups

oral iloperidone

Experimental group

Description:

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

Treatment:

Drug: Iloperidone

oral risperidone

Active Comparator group

Description:

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

Treatment:

Drug: Risperidone