Efficacy and Safety Study of Iloperidone Virus Risperidone to Treat Schizophrenia

Hansoh Pharma

Status and phase: Completed; Phase 2

Conditions: Iloperidone; Schizophrenia; Efficacy

Treatments: Drug: Risperidone; Drug: iloperidone

Study type: Interventional

Funder types: Industry

Identifiers

NCT01623713

YPLT20111123

Details and patient eligibility

About

The purpose of this study is to determine whether iloperidone is effective in the treatment of Schizophrenia.

Enrollment: 260 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Men or women ages 18-65 years old.
• DSM-IV diagnosis of schizophrenia.
• PANSS≥70.
• Of the 7 PANSS positive symptom subscale, at least two score ≥ 4 points.
• Written informed consent.

Exclusion criteria

• Pregnant or nursing (lactating) women, or women who plan on conceiving during the course of the study.
• Clinically significant disease of the heart,kidneys,liver,hematonosis or endocrine system.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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260 participants in 2 patient groups

Risperidone

Active Comparator group

Treatment:

Drug: Risperidone

iloperidone

Experimental group

Treatment:

Drug: iloperidone