Validating and Optimizing Model of Antipsychotics Selection

Schizophrenia Clinical Trial

Official title:

A Randomized Controlled Multi-center Clinical Study Focusing on Validating and Optimizing Model of Antipsychotics Selection in China

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03237052
• Other study ID #: VOMAS-C
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2018
• Est. completion date: December 2020

Study information

• Verified date: August 2019
• Source: Shanghai Mental Health Center
• Contact: Yifeng SHEN, MD PhD
• Phone: 86-21-34773657
• Email: shenyifeng[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: December 2020
• Est. primary completion date: September 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Other:
• model
a model that has been established in advance.
• non-model
real-world psychiatrist decision

Locations

Country	Name	City	State
China	Shanghai Mental Health Center	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Mental Health Center

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of PSP from Baseline	PSP assessment at 52 weeks	52 weeks
Secondary	Change of PANSS from Baseline	PANSS assessment at 52 weeks	52 weeks
Secondary	Change of CDSS from Baseline	CDSS assessment at 52 weeks	52 weeks
Secondary	Change of CGI from Baseline	CGI assessment at 52 weeks	52 weeks
Secondary	Change of liver function from Baseline	Liver function assessment at 52 weeks	52 weeks
Secondary	Change of PRL from Baseline	PRL assessment at 52 weeks	52 weeks
Secondary	Number of Participants with EPS	EPS assessment at 52 weeks	52 weeks
Secondary	Number of Participants with abnormal ECG	ECG assessment at 52 weeks	52 weeks
Secondary	Number of Participants with abnormal sexual function	sexual function assessment at 52 weeks	52 weeks