Status:
UNKNOWN
The Effect of a Community-based LAT-treated Management Model on the Violence Risk of Patients With Schizophrenia
Lead Sponsor:
Yi Li MD, PhD
Conditions:
Schizophrenia
Eligibility:
All Genders
18-60 years
Phase:
NA
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 ...
Detailed Description
This is a 49 weeks open-label,cluster randomized controlled study. Patients with schizophrenia and violence risk under the government supervision will be enrolled in the study. A community-based long-...
Eligibility Criteria
Inclusion
- Diagnosed as schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders , Fifth Edition (DSM-V)
- Had violent behavior such as smashing or breaking, threatening with a weapon, committing arson or explosion in the past one year, whether the behavior can be stopped by persuading or not;
- Living with a guardian or a caregiver;
- Informed consent from the patients or their guardians;
- Resulted negative in urine pregnancy test if female at their reproductive age; female subjects must take effective measures to prevent pregnancy during the whole study or have been postmenopausal.-
Exclusion
- Patients who have had suicidal ideation or suicidal attempts within 12 months before screening or in screening period;
- Intravenous drug abuse or Opioid dependence within 3 months before screening;
- Patients with treatment-resistant schizophrenia;
- Large dose of Clozapine (≥200mg/day) or other long-acting injectable antipsychotics used within 3 months or within 2 drug half-life periods before screening;
- Patients with any severe or unstable cardiovascular, respiratory, nervous system or other system diseases; clinically significant abnormality in laboratory examinations or ECG;
- Communication difficulties caused by cognitive impairment or unable to complete the assessments in the study;
- Patients assessed as unsuitable for the study in other reasons, such as allergic or intolerant to risperidone or paliperidone, resistant to risperidone or paliperidone (ineffective after adequate dosage and duration in medical history); unable to provide informed consent; historical treatments which might effect the results of the study; historical neuroleptic malignant syndrome or tardive dyskinesia.
Key Trial Info
Start Date :
May 5 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2020
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT03434210
Start Date
May 5 2018
End Date
October 1 2020
Last Update
August 2 2019
Active Locations (1)
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1
Wuhan mental health center
Wuhan, Wuhan, China, 430000