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

NCT04064476 | Unknown FDA Drug

• 1 other identifier: WG17A002II
• Study Type: observational
• Target: 225
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia

Keywords

schizophrenia; violence risk; long-acting antipsychotics

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (21)

• Modified Overt Aggression Scale (MOAS)

  49 Weeks

• Violence Risk Assessment For Psychiatric Patients

  49 Weeks

• Hospitalization frequency

  49 Weeks

• WHO Quality of Life-BREF (WHOQOL-BREF) of patients

  49 Weeks

• Visual Analogue Scale-100 (VAS 100) of caregiver treatment satisfaction

  49 Weeks

Interventions

Paliperidone Palmitate DRUG

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.

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Huazhong University of Science and Technology: lead

Study Sites (1)

Wuhan mental health center

Wuhan, Hubei, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

Will take blood sample and kept it for further analysis after get agreement from the subjects.

MeSH Terms

Conditions

Schizophrenia

Interventions

Paliperidone Palmitate

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Isoxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Study Officials

• Yi Li, Dorctor

  HuaZhong university, Wuhan mental health center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 25, 2019
• First Posted: August 22, 2019
• Study Start: August 18, 2019
• Primary Completion: August 15, 2021
• Study Completion: September 15, 2021
• Last Updated: February 20, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)