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

Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04064476
• Other study ID #: WG17A002II
• Status: Enrolling by invitation
• Start date: August 18, 2019
• Est. completion date: September 15, 2021

Study information

• Verified date: February 2020
• Source: Huazhong University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 225
• Est. completion date: September 15, 2021
• Est. primary completion date: August 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• Paliperidone Palmitate
This is a observational study, to see the effect of paliperidone palmitate on schizophrenia patient with violence risk. The intervention is determined by clinical practice in real world setting, only schizophrenia patient with violence risk and treated with Paliperidone Palmitate will be invited to join the observational study.

Locations

Country	Name	City	State
China	Wuhan mental health center	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Huazhong University of Science and Technology

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Hospitalization frequency	Hospitalization due to schizophrenia during 49 weeks	49 Weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Adverse events	The frequency of adverse events in the treatment period	49 Weeks
Secondary	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
Secondary	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
Secondary	Renal function tests	Renal function tests includes blood tests that provide information about blood urea nitrogen (BUN) and creatinine.	49 weeks
Secondary	Blood glucose tests	Using blood glucose monitoring to perform fingerprick type of glucose meter.	49 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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