Validating and Optimizing Model of Antipsychotics Selection

Not Applicable

• Conditions: Schizophrenia
• Interventions: Other: model; Other: non-model

• Registration Number: NCT03237052
• Lead Sponsor: Shanghai Mental Health Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-07-29
• Study First Submitted QC: 2017-07-29
• Study First Posted: 2017-08-02
• Study Start: 2018-01-01
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-07
• Last Update Posted: 2019-08-09
• Primary Completion: 2020-09
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 2000

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
model	model	model aided decision
non-model	non-model	real-world psychiatrist decision

Primary Outcome Measures

Name	Time	Method
Change of PSP from Baseline	52 weeks	PSP assessment at 52 weeks

Secondary Outcome Measures

Name	Time	Method
Change of PRL from Baseline	52 weeks	PRL assessment at 52 weeks
Number of Participants with abnormal ECG	52 weeks	ECG assessment at 52 weeks
Number of Participants with EPS	52 weeks	EPS assessment at 52 weeks
Change of liver function from Baseline	52 weeks	Liver function assessment at 52 weeks
Change of CGI from Baseline	52 weeks	CGI assessment at 52 weeks
Change of CDSS from Baseline	52 weeks	CDSS assessment at 52 weeks
Number of Participants with abnormal sexual function	52 weeks	sexual function assessment at 52 weeks
Change of PANSS from Baseline	52 weeks	PANSS assessment at 52 weeks

Trial Locations

Locations (1)

Shanghai Mental Health Center; 🇨🇳 Shanghai, Shanghai, China