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

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ClinicalTrials.gov Identifier: NCT04064476
Recruitment Status : Not yet recruiting
First Posted : August 22, 2019
Last Update Posted : August 22, 2019
Sponsor:
Information provided by (Responsible Party):
Yi Li MD, PhD, Huazhong University of Science and Technology

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.

Condition or disease Intervention/treatment
Schizophrenia 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.

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Study Type : Observational
Estimated Enrollment : 225 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Effect of Long-acting Antipsychotic on Schizophrenia Patients With Violence Risk : a Observational Cohort Study
Estimated Study Start Date : August 15, 2019
Estimated Primary Completion Date : August 15, 2021
Estimated Study Completion Date : September 15, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia


Intervention Details:
  • 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.


Primary Outcome Measures :
  1. Positive and Negative Syndrome Scale(PANSS) [ Time Frame: 49 Weeks ]
    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).


Secondary Outcome Measures :
  1. Modified Overt Aggression Scale (MOAS) [ Time Frame: 49 Weeks ]
    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

  2. Violence Risk Assessment For Psychiatric Patients [ Time Frame: 49 Weeks ]
    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.

  3. Hospitalization frequency [ Time Frame: 49 Weeks ]
    Hospitalization due to schizophrenia during 49 weeks

  4. WHO Quality of Life-BREF (WHOQOL-BREF) of patients [ Time Frame: 49 Weeks ]
    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.

  5. Visual Analogue Scale-100 (VAS 100) of caregiver treatment satisfaction [ Time Frame: 49 Weeks ]
    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

  6. Visual Analogue Scale-100 (VAS 100) of patients treatment satisfaction [ Time Frame: 49 Weeks ]
    The patients' VAS 100 score change. Patients rate according to their treatment satisfaction, score from 1( extremely unsatisfied) to 100( extremely satisfied.

  7. Visual Analogue Scale-100 (VAS 100) of caregiver's treatment satisfication [ Time Frame: 49 Weeks ]

    The caregivers' VAS 100 score change.Caregivers rate according to their treatment satisfication, score from

    1( extremely unsatisfied) to 100( extremely satisfied.


  8. Personal and Social Performance Scale (PSP) [ Time Frame: 49 Weeks ]
    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

  9. Treatment Emergent Symptom Scale (TESS) [ Time Frame: 49 Weeks ]

    Treatment Emergent Symptom Scale (TESS) is a checklist including common adverse event in psychotic treatment.

    each item rate from 0( no) to 4 (heavy)


  10. Electrocardiogram (ECG) [ Time Frame: 49 Weeks ]
    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

  11. Adverse events [ Time Frame: 49 Weeks ]
    The frequency of adverse events in the treatment period

  12. Calgary Depression Scale of Schizophrenia(CDSS) [ Time Frame: 49 weeks ]
    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.

  13. Liver function tests [ Time Frame: 49 weeks ]
    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).

  14. Renal function tests [ Time Frame: 49 weeks ]
    Renal function tests includes blood tests that provide information about blood urea nitrogen (BUN) and creatinine.

  15. Blood glucose tests [ Time Frame: 49 weeks ]
    Using blood glucose monitoring to perform fingerprick type of glucose meter.

  16. Blood lipid tests [ Time Frame: 49 weeks ]
    Liver function tests are groups of blood tests that provide information about high density lipoprotein (HDL), low density lipoprotein (LDL) and triglyceride.

  17. STROOP test [ Time Frame: 49 weeks ]
    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

  18. RBANS [ Time Frame: 49 weeks ]
    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

  19. Interpersonal Reactivity Index(IRI) [ Time Frame: 49 weeks ]
    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").

  20. Facial Emotion Recognition scale [ Time Frame: 49 weeks ]
    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.

  21. Toronto Alexithymia Scale(TAS) [ Time Frame: 49 weeks ]
    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.


Biospecimen Retention:   Samples With DNA
Will take blood sample and kept it for further analysis after get agreement from the subjects.


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04064476


Contacts
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Contact: Yongjie Zhou, Dorctor 027-85859431 qingzhu1108@126.com

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

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Responsible Party: Yi Li MD, PhD, Professor, Huazhong University of Science and Technology
ClinicalTrials.gov Identifier: NCT04064476     History of Changes
Other Study ID Numbers: WG17A002II
First Posted: August 22, 2019    Key Record Dates
Last Update Posted: August 22, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No share plan

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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
Keywords provided by Yi Li MD, PhD, Huazhong University of Science and Technology:
schizophrenia
violence risk
long-acting antipsychotics
Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Antipsychotic Agents
Paliperidone Palmitate
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin 5-HT2 Receptor Antagonists
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Dopamine D2 Receptor Antagonists
Dopamine Antagonists
Dopamine Agents