Schizophrenia Clinical Trial
Official title:
The Effect of a Community-based Long-acting Antipsychotic-treated Management Model on the Violence Risk of Patients With Schizophrenia: a 1-year, Open-label Randomized Controlled Study
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.
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, if they are able to use smart phones.
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. Previous oral antipsychotics could be continued or withdrawn in 2-4
weeks after first paliperidone palmitate administration according to doctors' clinical
judgement. Doctors have rights to decide whether a patient needs in-hospital treatment or
extramural hospital treatment. The study protocol does not limit other medication or
treatment measures except the injectable paliperidone palmitate. Other medication or
treatment measures should be decided according to doctors' clinical judgement and
negotiation with patients and guardians.
Subjects in control group will be treated with oral antipsychotics or other conventional
medication.
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