A Randomized Controlled Multi-center Clinical Study Focusing on Validating and Optimizing Model of Antipsychotics Selection in China
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Schizophrenia
- Sponsor
- Shanghai Mental Health Center
- Enrollment
- 2000
- Locations
- 1
- Primary Endpoint
- Change of PSP from Baseline
- Last Updated
- 6 years ago
Overview
Brief Summary
This multi-centre study will evaluate the clinical efficacy of 3 atypical antipsychotics treatment in Chinese Patients with Schizophrenia by comparing model-decision with real-world psychiatrist-decision. The three atypical antipsychotics are olanzapine (5-20 milligram per day), risperidone (2-6 milligram per day) and aripiprazole (5-30 milligram per day). The main purpose of this study is to explore the potential difference between modal-aided-decision with clinician-decision in order to validate and optimize the selection model that has been established in advance.
The efficacy evaluations include symptoms, social function, recurrence rate and hospitalization. Visits occurs at 0, 4, 8, 13, 26, 52 weeks.
Investigators
Eligibility Criteria
Inclusion Criteria
- •An in-patient or out-patient (male or female) and aged ≥18 years
- •A diagnosis of schizophrenia, DSM-5 (Diagnostic and Statistical Manual Diploma in Social Medicine-5)
- •Subjects must have the ability to effectively communicate with investigator, complete study related documents, comprehend the key components of the consent form and must provide written informed consent to participate in the study prior to any study specific assessments or procedures.
- •Patients are taking or will take atypical antipsychotics which include olanzapine, risperidone, aripiprazole.
- •Baseline PANSS Total Score ≥70
Exclusion Criteria
- •Participation in other clinical studies.
- •Known intolerance or lack of efficacy to olanzapine, risperidone or aripiprazole.
- •Use of clozapine within 28 days prior to randomization.
- •Other conditions which, in the investigator's judgment, render patients unsuitable for the clinical study.
Outcomes
Primary Outcomes
Change of PSP from Baseline
Time Frame: 52 weeks
PSP assessment at 52 weeks
Secondary Outcomes
- Change of PRL from Baseline(52 weeks)
- Number of Participants with abnormal ECG(52 weeks)
- Number of Participants with EPS(52 weeks)
- Change of CGI from Baseline(52 weeks)
- Change of liver function from Baseline(52 weeks)
- Change of CDSS from Baseline(52 weeks)
- Number of Participants with abnormal sexual function(52 weeks)
- Change of PANSS from Baseline(52 weeks)