drugset / Trial / NCT03080194

The Effect of a Community-based LAI-treated Management Model on the Violence Risk of Patients With Schizophrenia

NCT03080194

Phase 4 Unknown 150 enrolled Maosheng Fang
RandomizedParallel-groupOpen-labelTreatment

Summary

This is a 12-month open-label randomized controlled study. Patients with schizophrenia and violence risk under the government supervision will be enrolled in the study. A community-based long-acting antipsychotics-treated management model will be applied to the experimental group, which means that professional psychiatrists will provide guidance to primary-level mental health workers on the psychotic treatment, and monthly-injected long-acting antipsychotic, paliperidone palmitate, will be used in the schizophrenia treatment. Every subject in experimental group will be equipped with an intelligent robot capable at push-to-talk and push-to-view, allowing the patients and caregivers to contact doctors for assistance at any time. The subjects in experimental group will be injected with 150mg eq and 100mg eq paliperidone palmitate in the deltoid at the 1st and 8th day, and afterwards a flexible dose of paliperidone palmitate from 75 to 150mg eq will be administrated monthly according to clinical judgement. Subjects in control group will be treated with oral antipsychotics or other conventional medication.

Timeline

Start
2017-04
Primary completion
2018-04
Completion
2018-04

Drugs

EvaluationDrugModalityDoseRoute
Subject paliperidone palmitate Unknown 75 mg Intramuscular
Subject paliperidone palmitate Unknown 150 mg Intramuscular

Indications