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

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.

Study Overview

• Status: Unknown
• Conditions: Schizophrenia
• Intervention / Treatment: Drug: paliperidone palmitate; Drug: control group

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Yi Lee, Doctor; Phone Number: (+86)027-59372200; Email: psylee@163.com
• Study Contact Backup: Name: Yang Zhou, Doctor; Phone Number: (+86)027-85836687; Email: wuhanzhouyang777@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Diagnosed as schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders , Fifth Edition (DSM-V) and rated under 70 in PANSS;
• Had violent behavior such as smashing or breaking, threatening with a weapon, commiting arson or explosion in the past one year, whether the behavior can be stopped by persuading or not;
• Living with a guardian or a caregiver;
• Informed consent from the patients or their guardians;
• Resulted negative in urine pregnancy test if female at their reproductive age; female subjects must take effective measures to prevent pregnancy during the whole study or have been postmenopausal.

Exclusion Criteria:

• Patients who have had suicidal ideation or suicidal attempts within 12 months before screening or in screening period;
• Intravenous drug abuse or Opioid dependence within 3 months before screening;
• Patients with treatment-resistant schizophrenia;
• Large dose of Clozapine (≥200mg/day) or other long-acting injectable antipsychotics used within 3 months or within 2 drug half-life periods before screening;
• Patients with any severe or unstable cardiovascular, respiratory, nervous system or other system diseases; clinically significant abnormality in laboratory examinations or ECG;
• Communication difficulties caused by cognitive impairment or unable to complete the assessments in the study;
• Patients assessed as unsuitable for the study in other reasons, such as allergic or intolerant to risperidone or paliperidone, resistant to risperidone or paliperidone (ineffective after adequate dosage and duration in medical history); unable to provide informed consent; historical treatments which might effect the results of the study; historical neuroleptic malignant syndrome or tardive dyskinesia.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: paliperidone palmitate group; 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.	Drug: paliperidone palmitate; 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.; Other Names: Sustenna
Active Comparator: control group; The subjects in control group will be applied with oral antipsychotics or other conventional medication.	Drug: control group; Subject in control group will be applied with oral antipsychotics or other conventional medication.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Violence Risk Assessment For Severe Psychiatric Patients	The percentage of subjects rated as no or low risk (scored 0 or 1) in Violence Risk Assessment For Severe Psychiatric Patients after 1-year treatment	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Modified Overt Aggression Scale (MOAS)	Patients' rated score in Modified Overt Aggression Scale after 1-year treatment	1 year
Health economic evaluation	The patients' and the caregivers' health economic questionnaire after 1-year treatment	1 year
Positive and Negative Syndrome Scale (PANSS)	PANSS total score after 6-month and 1-year treatment	1 year
Hospitalization frequency	Hospitalization frequency after 6-month and 1-year treatment	1 year
WHO Quality of Life-BREF (WHOQOL-BREF)	The patients' and the caregivers' WHOQOL-BREF score after 6-month and 1-year treatment	1 year
Visual Analogue Scale-100 (VAS 100)	The patients' and the caregivers' VAS 100 score after 6-month and 1-year treatment	1 year
Family Burden Scale of Diseases (FBS)	Family burden of the patient's family	1 year
Personal and Social Performance Scale (PSP)	PSP global score after 6-month and 1-year treatment	1 year
Treatment Emergent Symptom Scale (TESS)	Treatment Emergent Symptom Scale (TESS) score after 6-month and 1-year treatment	1 year
Vital signs	Heart rate and blood pressure after 6-month and 1-year treatment	1 year
Clinical laboratory examination	Blood routine examination after 6-month and 1-year treatment	1 year
Electrocardiogram (ECG)	Electrocardiogram (ECG) after 6-month and 1-year treatment	1 year
Adverse events	The frequency of adverse events in the treatment period	1 year

Collaborators and Investigators

• Sponsor: Maosheng Fang
• Investigators: Study Director: Yi Lee, Doctor, Wuhan Mental Health Centre

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2017
• Primary Completion (Anticipated): April 1, 2018
• Study Completion (Anticipated): April 1, 2018

Study Registration Dates

• First Submitted: March 2, 2017
• First Submitted That Met QC Criteria: March 14, 2017
• First Posted (Actual): March 15, 2017

Study Record Updates

• Last Update Posted (Actual): April 25, 2017
• Last Update Submitted That Met QC Criteria: April 22, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: schizophrenia; community-based; violence risk; long-acting antipsychotics
• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Agents; Dopamine Agents; Serotonin 5-HT2 Receptor Antagonists; Serotonin Antagonists; Dopamine D2 Receptor Antagonists; Dopamine Antagonists; Paliperidone Palmitate
• Other Study ID Numbers: WG17A001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No