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.
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.
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.
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)
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
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
Hospitalization frequency
Hospitalization due to schizophrenia during 49 weeks
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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)
Measured: 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
Measured: 49 Weeks
Adverse events
The frequency of adverse events in the treatment period
Measured: 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.
Measured: 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).
Measured: 49 weeks
Renal function tests
Renal function tests includes blood tests that provide information about blood urea nitrogen (BUN) and creatinine.
Measured: 49 weeks
Blood glucose tests
Using blood glucose monitoring to perform fingerprick type of glucose meter.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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").
Measured: 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.
Measured: 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.
Measured: 49 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2019
- Study start18 Aug 2019
- Primary completion15 Aug 2021 (estimated)
- Study completion15 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Huazhong University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yi Li MD, PhD, Huazhong University of Science and Technology
- Investigators
- Yi Li, Dorctor, Principal investigator, HuaZhong university, Wuhan mental health center
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
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Long-acting Antipsychotic on Schizophrenia Patients With Violence Risk : a Observational Cohort Study
- ClinicalTrials.gov ID
- NCT04064476
- Acronym / sponsor ID
- WG17A002II
- Conditions
- Schizophrenia
- Keywords
- schizophrenia, violence risk, long-acting antipsychotics
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 225 participants (estimated)
- Lead sponsor
- Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 18 Aug 2019 (actual)
- Primary completion
- 15 Aug 2021 (estimated)
- Study completion
- 15 Sep 2021 (estimated)
- First posted
- 22 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Paliperidone PalmitateThis 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. | Drug | – |
Primary outcome
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).
21 secondary outcomes
Modified Overt Aggression Scale (MOAS)
Time frame: 49 Weeks
Violence Risk Assessment For Psychiatric Patients
Time frame: 49 Weeks
Hospitalization frequency
Time frame: 49 Weeks
WHO Quality of Life-BREF (WHOQOL-BREF) of patients
Time frame: 49 Weeks
Visual Analogue Scale-100 (VAS 100) of caregiver treatment satisfaction
Time frame: 49 Weeks
Visual Analogue Scale-100 (VAS 100) of patients treatment satisfaction
Time frame: 49 Weeks
Visual Analogue Scale-100 (VAS 100) of caregiver's treatment satisfication
Time frame: 49 Weeks
Personal and Social Performance Scale (PSP)
Time frame: 49 Weeks
Treatment Emergent Symptom Scale (TESS)
Time frame: 49 Weeks
Electrocardiogram (ECG)
Time frame: 49 Weeks
Adverse events
Time frame: 49 Weeks
Calgary Depression Scale of Schizophrenia(CDSS)
Time frame: 49 weeks
Liver function tests
Time frame: 49 weeks
Renal function tests
Time frame: 49 weeks
Blood glucose tests
Time frame: 49 weeks
Blood lipid tests
Time frame: 49 weeks
STROOP test
Time frame: 49 weeks
RBANS
Time frame: 49 weeks
Interpersonal Reactivity Index(IRI)
Time frame: 49 weeks
Facial Emotion Recognition scale
Time frame: 49 weeks
Toronto Alexithymia Scale(TAS)
Time frame: 49 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2020.
- Individual participant dataSharing planned: No. No share plan
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yi Li, Dorctor principal investigator
HuaZhong university, Wuhan mental health center
1 site in 1 country: see every site and its status.
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.