Clinical trial NCT04064476: The Effect of Long-acting Antipsychotics on Schizophrenia Patients With Violence Risk
Official title: The Effect of Long-acting Antipsychotic on Schizophrenia Patients With Violence Risk : a Observational Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Schizophrenia
Keywords: schizophrenia
violence risk
long-acting antipsychotics
Lead sponsor: Huazhong University of Science and Technology
Sponsor class: OTHER
First posted: 2019-08-22
Enrollment: 225
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient who has violence risk and in the supervise of government system, and treated with paliperidone palmitate, and signed the informed consent.

Brief summary: This is a 49 weeks prospective, non-interventional cohort study. To observe the effect of long-acting injection antipsychotic(LAI), paliperidone palmitate on prevention of recurrence and symptom control in schizophrenia patients with violence risk. This study can be extended according to the implementation of the project and extended follow-up time.

Detailed description: This is a 49 weeks prospective, observational cohort study. Wuhan initiated a project to improve the LAI treatment in schizophrenia patient with violence risk. This observational study will build the cohort of schizophrenia patient with violence risk and treated with LAI paliperidone palmitate. The effect of long-acting antipsychotic, paliperidone palmitate, will be observed on prevention of recurrence and symptom control in these patients. safety information and laboratory tests result will also be collected. This study can be extended according to the implementation of the project and extended follow-up time.

Eligibility criteria: Patient who has violence risk and in the supervise of government system, and treated with paliperidone palmitate will be invited to the observational study.

Primary outcomes:
measure: Positive and Negative Syndrome Scale(PANSS)
timeFrame: 49 Weeks
Secondary outcomes:
measure: Modified Overt Aggression Scale (MOAS)
timeFrame: 49 Weeks
measure: Violence Risk Assessment For Psychiatric Patients
timeFrame: 49 Weeks
measure: Hospitalization frequency
timeFrame: 49 Weeks
measure: WHO Quality of Life-BREF (WHOQOL-BREF) of patients
timeFrame: 49 Weeks
measure: Visual Analogue Scale-100 (VAS 100) of caregiver treatment satisfaction
timeFrame: 49 Weeks
measure: Visual Analogue Scale-100 (VAS 100) of patients treatment satisfaction
timeFrame: 49 Weeks
measure: Visual Analogue Scale-100 (VAS 100) of caregiver's treatment satisfication
timeFrame: 49 Weeks
measure: Personal and Social Performance Scale (PSP)
timeFrame: 49 Weeks
measure: Treatment Emergent Symptom Scale (TESS)
timeFrame: 49 Weeks
measure: Electrocardiogram (ECG)
timeFrame: 49 Weeks
measure: Adverse events
timeFrame: 49 Weeks
measure: Calgary Depression Scale of Schizophrenia(CDSS)
timeFrame: 49 weeks
measure: Liver function tests
timeFrame: 49 weeks
measure: Renal function tests
timeFrame: 49 weeks
measure: Blood glucose tests
timeFrame: 49 weeks
measure: Blood lipid tests
timeFrame: 49 weeks
measure: STROOP test
timeFrame: 49 weeks
measure: RBANS
timeFrame: 49 weeks
measure: Interpersonal Reactivity Index(IRI)
timeFrame: 49 weeks
measure: Facial Emotion Recognition scale
timeFrame: 49 weeks
measure: Toronto Alexithymia Scale(TAS)
timeFrame: 49 weeks
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Wuhan mental health center
state: Hubei
Study officials:
affiliation: HuaZhong university, Wuhan mental health center
name: Yi Li, Dorctor
role: PRINCIPAL_INVESTIGATOR
References: