The Effect of Long-acting Antipsychotics on Schizophrenia Patients With Violence Risk
NCT04064476, Unknown, Huazhong University of Science and Technology
Trial 9
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | The Effect of Long-acting Antipsychotics on Schizophrenia Patients With Violence Risk | ClinicalTrials.gov |
| NCT number | NCT04064476 | ClinicalTrials.gov |
| Status | Unknown | ClinicalTrials.gov |
| Enrollment | 225 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Huazhong University of Science and Technology | ClinicalTrials.gov |
| Conditions | Schizophrenia | ClinicalTrials.gov |
| Interventions | Paliperidone Palmitate | ClinicalTrials.gov |
| First posted | 2019-08-22 | ClinicalTrials.gov |
| Last updated | 2020-02-20 | ClinicalTrials.gov |
Registered outcomes 22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Positive and Negative Syndrome Scale(PANSS) | 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). | ClinicalTrials.gov |
| Secondary | Modified Overt Aggression Scale (MOAS) | 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 | ClinicalTrials.gov |
| Secondary | Violence Risk Assessment For Psychiatric Patients | 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. | ClinicalTrials.gov |
| Secondary | Hospitalization frequency | 49 Weeks | Hospitalization due to schizophrenia during 49 weeks | ClinicalTrials.gov |
| Secondary | WHO Quality of Life-BREF (WHOQOL-BREF) of patients | 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. | ClinicalTrials.gov |
| Secondary | Visual Analogue Scale-100 (VAS 100) of caregiver treatment satisfaction | 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 | ClinicalTrials.gov |
| Secondary | Visual Analogue Scale-100 (VAS 100) of patients treatment satisfaction | 49 Weeks | The patients' VAS 100 score change. Patients rate according to their treatment satisfaction, score from 1( extremely unsatisfied) to 100( extremely satisfied. | ClinicalTrials.gov |
| Secondary | Visual Analogue Scale-100 (VAS 100) of caregiver's treatment satisfication | 49 Weeks | The caregivers' VAS 100 score change.Caregivers rate according to their treatment satisfication, score from 1( extremely unsatisfied) to 100( extremely satisfied. | ClinicalTrials.gov |
| Secondary | Personal and Social Performance Scale (PSP) | 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 | ClinicalTrials.gov |
| Secondary | Treatment Emergent Symptom Scale (TESS) | 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) | ClinicalTrials.gov |
| Secondary | Electrocardiogram (ECG) | 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 | ClinicalTrials.gov |
| Secondary | Adverse events | 49 Weeks | The frequency of adverse events in the treatment period | ClinicalTrials.gov |
| Secondary | Calgary Depression Scale of Schizophrenia(CDSS) | 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. | ClinicalTrials.gov |
| Secondary | Liver function tests | 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). | ClinicalTrials.gov |
| Secondary | Renal function tests | 49 weeks | Renal function tests includes blood tests that provide information about blood urea nitrogen (BUN) and creatinine. | ClinicalTrials.gov |
| Secondary | Blood glucose tests | 49 weeks | Using blood glucose monitoring to perform fingerprick type of glucose meter. | ClinicalTrials.gov |
| Secondary | Blood lipid tests | 49 weeks | Liver function tests are groups of blood tests that provide information about high density lipoprotein (HDL), low density lipoprotein (LDL) and triglyceride. | ClinicalTrials.gov |
| Secondary | STROOP test | 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 | ClinicalTrials.gov |
| Secondary | RBANS | 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 | ClinicalTrials.gov |
| Secondary | Interpersonal Reactivity Index(IRI) | 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"). | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 1
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)