Clinical trial NCT03080194: The Effect of a Community-based LAI-treated Management Model on the Violence Risk of Patients With Schizophrenia
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Schizophrenia
Keywords: schizophrenia
violence risk
long-acting antipsychotics
community-based
Lead sponsor: Huazhong University of Science and Technology
Sponsor class: OTHER
First posted: 2017-03-15
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Violence Risk Assessment For Severe Psychiatric Patients
timeFrame: 1 year
Secondary outcomes:
measure: Modified Overt Aggression Scale (MOAS)
timeFrame: 1 year
measure: Health economic evaluation
timeFrame: 1 year
measure: Positive and Negative Syndrome Scale (PANSS)
timeFrame: 1 year
measure: Hospitalization frequency
timeFrame: 1 year
measure: WHO Quality of Life-BREF (WHOQOL-BREF)
timeFrame: 1 year
measure: Visual Analogue Scale-100 (VAS 100)
timeFrame: 1 year
measure: Family Burden Scale of Diseases (FBS)
timeFrame: 1 year
measure: Personal and Social Performance Scale (PSP)
timeFrame: 1 year
measure: Treatment Emergent Symptom Scale (TESS)
timeFrame: 1 year
measure: Vital signs
timeFrame: 1 year
measure: Clinical laboratory examination
timeFrame: 1 year
measure: Electrocardiogram (ECG)
timeFrame: 1 year
measure: Adverse events
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
affiliation: Wuhan Mental Health Centre
name: Yi Lee, Doctor
role: STUDY_DIRECTOR
References: