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This is a 12-month open-label randomized controlled study. Patients with schizophrenia and violence risk under the government supervision will be enrolled in the study. A community-based long-acting antipsychotics-treated management model will be applied to the experimental group, which means that professional psychiatrists will provide guidance to primary-level mental health workers on the psychotic treatment, and monthly-injected long-acting antipsychotic, paliperidone palmitate, will be used in the schizophrenia treatment. Every subject in experimental group will be equipped with an intelligent robot capable at push-to-talk and push-to-view, allowing the patients and caregivers to contact doctors for assistance at any time.
The subjects in experimental group will be injected with 150mg eq and 100mg eq paliperidone palmitate in the deltoid at the 1st and 8th day, and afterwards a flexible dose of paliperidone palmitate from 75 to 150mg eq will be administrated monthly according to clinical judgement.
Subjects in control group will be treated with oral antipsychotics or other conventional medication.
This is a 12-month open-label randomized controlled study. Patients with schizophrenia and violence risk under the government supervision will be enrolled in the study. A community-based long-acting antipsychotics-treated management model will be applied to the experimental group, which means that professional psychiatrists will provide guidance to primary-level mental health workers on the psychotic treatment, and monthly-injected long-acting antipsychotic, paliperidone palmitate, will be used in the schizophrenia treatment. Every subject in experimental group will be equipped with an intelligent robot capable at push-to-talk and push-to-view, allowing the patients and caregivers to contact doctors for assistance at any time, if they are able to use smart phones.
The subjects in experimental group will be injected with 150mg eq and 100mg eq paliperidone palmitate in the deltoid at the 1st and 8th day, and afterwards a flexible dose of paliperidone palmitate from 75 to 150mg eq will be administrated monthly according to clinical judgement. Previous oral antipsychotics could be continued or withdrawn in 2-4 weeks after first paliperidone palmitate administration according to doctors' clinical judgement. Doctors have rights to decide whether a patient needs in-hospital treatment or extramural hospital treatment. The study protocol does not limit other medication or treatment measures except the injectable paliperidone palmitate. Other medication or treatment measures should be decided according to doctors' clinical judgement and negotiation with patients and guardians.
Subjects in control group will be treated with oral antipsychotics or other conventional medication.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| paliperidone palmitate group | Experimental | The subjects in experimental group will be injected with 150mg eq and 100mg eq paliperidone palmitate in the deltoid at the 1st and 8th day, and afterwards a flexible dose of paliperidone palmitate from 75 to 150mg eq will be administrated monthly according to clinical judgement. |
|
| control group | Active Comparator | The subjects in control group will be applied with oral antipsychotics or other conventional medication. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| paliperidone palmitate | Drug | Subjects in experimental group will be injected with 150mg eq and 100mg eq paliperidone palmitate in the deltoid at the 1st and 8th day, and afterwards a flexible dose of paliperidone palmitate from 75 to 150mg eq will be administrated monthly according to clinical judgement. Previous oral antipsychotics could be continued or withdrawn in 2-4 weeks after first paliperidone palmitate administration according to doctors' clinical judgement. |
| Measure | Description | Time Frame |
|---|---|---|
| Violence Risk Assessment For Severe Psychiatric Patients | The percentage of subjects rated as no or low risk (scored 0 or 1) in Violence Risk Assessment For Severe Psychiatric Patients after 1-year treatment | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Modified Overt Aggression Scale (MOAS) | Patients' rated score in Modified Overt Aggression Scale after 1-year treatment | 1 year |
| Health economic evaluation | The patients' and the caregivers' health economic questionnaire after 1-year treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yi Lee, Doctor | Contact | (+86)027-59372200 | psylee@163.com | |
| Yang Zhou, Doctor | Contact | (+86)027-85836687 | wuhanzhouyang777@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Yi Lee, Doctor | Wuhan Mental Health Centre | Study Director |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000068882 | Paliperidone Palmitate |
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D007555 | Isoxazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| control group | Drug | Subject in control group will be applied with oral antipsychotics or other conventional medication. |
|
| 1 year |
| Positive and Negative Syndrome Scale (PANSS) | PANSS total score after 6-month and 1-year treatment | 1 year |
| Hospitalization frequency | Hospitalization frequency after 6-month and 1-year treatment | 1 year |
| WHO Quality of Life-BREF (WHOQOL-BREF) | The patients' and the caregivers' WHOQOL-BREF score after 6-month and 1-year treatment | 1 year |
| Visual Analogue Scale-100 (VAS 100) | The patients' and the caregivers' VAS 100 score after 6-month and 1-year treatment | 1 year |
| Family Burden Scale of Diseases (FBS) | Family burden of the patient's family | 1 year |
| Personal and Social Performance Scale (PSP) | PSP global score after 6-month and 1-year treatment | 1 year |
| Treatment Emergent Symptom Scale (TESS) | Treatment Emergent Symptom Scale (TESS) score after 6-month and 1-year treatment | 1 year |
| Vital signs | Heart rate and blood pressure after 6-month and 1-year treatment | 1 year |
| Clinical laboratory examination | Blood routine examination after 6-month and 1-year treatment | 1 year |
| Electrocardiogram (ECG) | Electrocardiogram (ECG) after 6-month and 1-year treatment | 1 year |
| Adverse events | The frequency of adverse events in the treatment period | 1 year |
| D011743 |
| Pyrimidines |
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
| D008722 | Methods |