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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

288 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Brief Summary

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

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Detailed Description

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

Conditions

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Schizophrenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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oral iloperidone

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

Group Type EXPERIMENTAL

Iloperidone

Intervention Type DRUG

oral risperidone

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

Group Type ACTIVE_COMPARATOR

Risperidone

Intervention Type DRUG

Interventions

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Iloperidone

Intervention Type DRUG

Risperidone

Intervention Type DRUG

Eligibility Criteria

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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。

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No