The Effect of Long-acting Antipsychotics on Schizophrenia Patients With Violence Risk

The Effect of Long-acting Antipsychotic on Schizophrenia Patients With Violence Risk : a Observational Cohort Study

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.

Study Overview

• Status: Unknown
• Conditions: Schizophrenia
• Intervention / Treatment: Drug: Paliperidone Palmitate

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.

• Study Type: Observational
• Enrollment (Anticipated): 225

Contacts and Locations

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China
      • Wuhan Mental Health Center

Participation Criteria

Eligibility Criteria

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

• 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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Positive and Negative Syndrome Scale(PANSS)	PANSS score change. PANSS was used to assess schizophrenia psychopathology symptoms of subjects. PANSS gave a total score (total score of 30 items) and three subscale scores, positive subscale (7 items), negative subscale (7 items), general psychopathology symptoms subscale (16 items) . Each scale rated from 1 (none) to 7 (very heavy).	49 Weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Modified Overt Aggression Scale (MOAS)	Score change of Modified Overt Aggression Scale (MOAS ). MOAS is used to assess aggressive behavior of psychosis patients. Including Verbal aggressive, aggressive to property, aggressive to self, aggressive to others, and total score. Each domain with score 0 to 4, total weighted score 0 to 40	49 Weeks
Hospitalization frequency	Hospitalization due to schizophrenia during 49 weeks	49 Weeks
WHO Quality of Life-BREF (WHOQOL-BREF) of patients	The patients' WHOQOL-BREF score. The WHOQOL-BREF offers a short, generic, subjective quality of life (QoL) measure, 26 important questions are scored in environmental, social, physical and psychological domains, each question from 1-5.	49 Weeks
Personal and Social Performance Scale (PSP)	PSP was a clinical scoring tool that was used for personal and social function assessment in schizophrenia subjects, and the score ranged between 1 and 100. The scale defined a continuous functional status, from overall function impaired (completely lack of independent basic functions, survival is significantly dangerous) to function well. The scale takes four functional dimensions into account: a) social useful activities, including work and study, b) the relationship between the individual and society, c) self-care, and d) disturbing and aggression	49 Weeks
Violence Risk Assessment For Psychiatric Patients	The Violence risk assessment scale for psychotic patients is a 0-5 score scale, established by the China national working group and used in the China National Continuing Management and Intervention Program for Psychoses, to evaluate psychotic patients' risk of violence [12]. 0 is no violence. 1 is verbal threat, shouting, but without aggressive behavior. 2 is beating or smashing property, limited in home. 3 is beating or smashing property in any place, cannot be dissuaded, but did not hurt people. 4. Consistently beating or smashing property or people in any place, cannot be dissuaded. 5, Any violent behavior with the dangerous weapon, or arson.	49 Weeks
Visual Analogue Scale-100 (VAS 100) of caregiver treatment satisfaction	The Caregiver' VAS 100 score change. caregiver rate according to their treatment satisfaction, score from 1( extremely unsatisfied) to 100( extremely satisfied. measure, 26 important questions are scored in environmental, social, physical and psychological domains, each question from 1-5	49 Weeks
Visual Analogue Scale-100 (VAS 100) of patients treatment satisfaction	The patients' VAS 100 score change. Patients rate according to their treatment satisfaction, score from 1( extremely unsatisfied) to 100( extremely satisfied.	49 Weeks
Visual Analogue Scale-100 (VAS 100) of caregiver's treatment satisfication	The caregivers' VAS 100 score change.Caregivers rate according to their treatment satisfication, score from 1( extremely unsatisfied) to 100( extremely satisfied.	49 Weeks
Treatment Emergent Symptom Scale (TESS)	Treatment Emergent Symptom Scale (TESS) is a checklist including common adverse event in psychotic treatment. each item rate from 0( no) to 4 (heavy)	49 Weeks
Electrocardiogram (ECG)	ECG testing should be performed in a quiet non-interference (such as TV, mobile) environment for the subjects. Before testing ECG the subjects should rest in the supine position for at least 5 minutes and should be limited to conversation or physical activity. Twelve-lead ECG was recorded by 25 mm/sec paper speed, measuring RR, PR, QRS and QT intervals	49 Weeks
Adverse events	The frequency of adverse events in the treatment period	49 Weeks
Calgary Depression Scale of Schizophrenia(CDSS)	Calgary Depression Scale of Schizophrenia is a scale to assess the depression symptom in schizophrenia patients, It comprises of 9 items, each item has 4 grade(0, 1, 2, 3), the higher score means more serious depression. Maximize score is 27 points. Above 6 points reflect has depression symptom.	49 weeks
Liver function tests	Liver function tests are groups of blood tests that provide information about the state of a patient's liver. In this case includes alanine transaminase (ALT) and aspartate transaminase (AST).	49 weeks
Renal function tests	Renal function tests includes blood tests that provide information about blood urea nitrogen (BUN) and creatinine.	49 weeks
Blood glucose tests	Using blood glucose monitoring to perform fingerprick type of glucose meter.	49 weeks
Blood lipid tests	Liver function tests are groups of blood tests that provide information about high density lipoprotein (HDL), low density lipoprotein (LDL) and triglyceride.	49 weeks
STROOP test	The test is considered to measure selective attention, cognitive flexibility and processing speed, and it is used as a tool in the evaluation of executive functions. The color of the character should be named both in undisturbed and disturbed condition. The time spent in both cases will be compared	49 weeks
RBANS	Repeatable Battery for the Assessment of Neuro-psychological Status (RBANS), The RBANS provides SS based on same-aged peers for 5 indexes of neuropsychological functioning: Attention, Language, Visuospatial-Construction, Immediate Memory, and Delayed Memory . These indexes combine to compute a total scale score of cognitive functioning	49 weeks
Interpersonal Reactivity Index(IRI)	Interpersonal Reactivity Index. The IRI was designed to assess empathy.It contains 4 sub-scales, each with 7 items. It uses a 5-item Likert scale with two anchors (A = Does not describe me well; E= Describes me very well). Responses can be averaged (using 0 to 4 or 1 to 5 endpoints) or summed (using 0 to 28 or 7 to 35 ranges). The IRI is a continuous measure of empathy in normal populations and not a categorical ,measure ("high empathy" versus "low empathy").	49 weeks
Facial Emotion Recognition scale	Computer-morphed images derived from the facial features of real individuals, each showing a specific emotion, are displayed on the screen, one at a time. Each face is displayed for 200ms and then immediately covered up to prevent residual processing of the image. The participant must select which emotion the face displayed from 6 options (sadness, happiness, fear, anger, disgust or surprise). The outcome measures for ERT cover percentages and numbers correct or incorrect and overall response latencies, which can be looked at either across individual emotions or across all emotions at once.	49 weeks
Toronto Alexithymia Scale(TAS)	Toronto Alexithymia Scale, the TAS is a 20-item instrument that commonly used measures of alexithymia. It is a self-report scale that is comprised of 20 items. Items are rated using a 5-point Likert scale whereby 1 = strongly disagree and 5 = strongly agree. There are 5 items that are negatively keyed (items 4, 5, 10, 18 and 19). The total alexithymia score is the sum of responses to all 20 items, while the score for each subscale factor is the sum of the responses to that subscale. The TAS-20 uses cutoff scoring: equal to or less than 51 = non-alexithymia, equal to or greater than 61 = alexithymia. Scores of 52 to 60 = possible alexithymia.	49 weeks

Collaborators and Investigators

• Sponsor: Huazhong University of Science and Technology
• Investigators: Principal Investigator: Yi Li, Dorctor, HuaZhong university, Wuhan mental health center

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 18, 2019
• Primary Completion (ANTICIPATED): August 15, 2021
• Study Completion (ANTICIPATED): September 15, 2021

Study Registration Dates

• First Submitted: July 25, 2019
• First Submitted That Met QC Criteria: August 20, 2019
• First Posted (ACTUAL): August 22, 2019

Study Record Updates

• Last Update Posted (ACTUAL): February 20, 2020
• Last Update Submitted That Met QC Criteria: February 19, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: schizophrenia; 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: WG17A002II

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No share plan

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