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SchizophreniaNCT04064476

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

An observational study of Schizophrenia, run by Huazhong University of Science and Technology at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Schizophrenia
What is being tested?
Paliperidone Palmitate
How many people
225 participants
Where
1 siteChina
Study dates
18 Aug 2019to 15 Sep 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

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.

Trial locations and contacts

1 site in 1 country.

China1 site
  • Wuhan mental health center

    Wuhan, Hubei

Other trials in China

About this study

Official title: 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.

Read the 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.

Conditions
Schizophrenia
Being tested
Paliperidone Palmitate
Keywords
schizophrenia, violence risk, long-acting antipsychotics
Medical subject headings
Schizophrenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Paliperidone PalmitateDrug

    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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: 49 Weeks

Secondary outcomes (21)
  1. 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

    Measured: 49 Weeks

  2. 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.

    Measured: 49 Weeks

  3. Hospitalization frequency

    Hospitalization due to schizophrenia during 49 weeks

    Measured: 49 Weeks

  4. 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.

    Measured: 49 Weeks

  5. 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

    Measured: 49 Weeks

  6. 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.

    Measured: 49 Weeks

  7. 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.

    Measured: 49 Weeks

  8. 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

    Measured: 49 Weeks

  9. 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)

    Measured: 49 Weeks

  10. 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

    Measured: 49 Weeks

  11. Adverse events

    The frequency of adverse events in the treatment period

    Measured: 49 Weeks

  12. 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.

    Measured: 49 weeks

  13. 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).

    Measured: 49 weeks

  14. Renal function tests

    Renal function tests includes blood tests that provide information about blood urea nitrogen (BUN) and creatinine.

    Measured: 49 weeks

  15. Blood glucose tests

    Using blood glucose monitoring to perform fingerprick type of glucose meter.

    Measured: 49 weeks

  16. 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.

    Measured: 49 weeks

  17. 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

    Measured: 49 weeks

  18. 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

    Measured: 49 weeks

  19. 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").

    Measured: 49 weeks

  20. 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.

    Measured: 49 weeks

  21. 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.

    Measured: 49 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Aug 2019
  2. Study start18 Aug 2019
  3. Primary completion15 Aug 2021 (estimated)
  4. Study completion15 Sep 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
225 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04064476
Sponsor's protocol ID
WG17A002II
Status last verified
Feb 2020
First submitted
25 Jul 2019
Last updated
20 Feb 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: No share plan

Questions about this trial

What is this clinical trial studying?

An observational study of Schizophrenia, run by Huazhong University of Science and Technology at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 20 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Positive and Negative Syndrome Scale(PANSS) (time frame: 49 Weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2020.

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