Ignite Creation Date:
2024-05-06 @ 11:06 AM
Last Modification Date:
2024-10-26 @ 12:40 PM
Study NCT ID:
NCT03434210
Status:
UNKNOWN
Last Update Posted:
2019-08-02
First Post:
2018-02-02
Brief Title:
The Effect of a Community-based LAT-treated Management Model on the Violence Risk of Patients With Schizophrenia
Sponsor:
Yi Li MD PhD
Organization:
Huazhong University of Science and Technology
Study Overview
Official Title:
The Effect of a Community-based Long-acting Antipsychotic-treated Management Model on the Violence Risk of Patients With Schizophrenia a 49 Weeks Open-label Cluster Randomized Controlled Study
Status:
UNKNOWN
Status Verified Date:
2019-08
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a 49 weeks open-label randomized controlled study Patients with schizophrenia and violence risk 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 Subjects in control group will be treated and cared as usual
Detailed Description:
This is a 49 weeks open-labelcluster 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 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 per clinical judgement For subjects who did not take risperidone paliperidone extended release tablets risperidone microspheres or paliperidone palmitate for injection previously subjects should take oral paliperidone or risperidone sustained release tablets in the screening phase to perform ultra-sensitive test the minimum dose of risperidone 1 mgday and the minimum dose of sustained-release tablets paliperidone 3 mgday at least orally three days Only subjects who were judged by the treating physician as tolerance to the drug could usepaliperidone palmitate Suggest previous antipsychotics could be withdrawn within 4 weeks after first paliperidone palmitate administration but will follow doctors clinical judgement The study protocol does not limit other medication or treatment measures except the injectable paliperidone palmitate Other medication or treatment measures should be decided by doctors clinical judgement and align with patients and caregiversSubjects in control group will be treated and cared as usual
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None