Validating and Optimizing Model of Antipsychotics Selection

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

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.

Study Overview

• Status: Unknown
• Conditions: Schizophrenia
• Intervention / Treatment: Other: model; Other: non-model

• Study Type: Interventional
• Enrollment (Anticipated): 2000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200030
      • Recruiting
      • Shanghai Mental Health Center
      • Contact: Yifeng SHEN, MD; Phone Number: +862134773657

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: model; model aided decision	Other: model; a model that has been established in advance.; Other Names: model aided decision
Active Comparator: non-model; real-world psychiatrist decision	Other: non-model; real-world psychiatrist decision; Other Names: non-model decision

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of PSP from Baseline	PSP assessment at 52 weeks	52 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of PANSS from Baseline	PANSS assessment at 52 weeks	52 weeks
Change of CDSS from Baseline	CDSS assessment at 52 weeks	52 weeks
Change of CGI from Baseline	CGI assessment at 52 weeks	52 weeks
Change of liver function from Baseline	Liver function assessment at 52 weeks	52 weeks
Change of PRL from Baseline	PRL assessment at 52 weeks	52 weeks
Number of Participants with EPS	EPS assessment at 52 weeks	52 weeks
Number of Participants with abnormal ECG	ECG assessment at 52 weeks	52 weeks
Number of Participants with abnormal sexual function	sexual function assessment at 52 weeks	52 weeks

Collaborators and Investigators

• Sponsor: Shanghai Mental Health Center
• Investigators: Principal Investigator: Yifeng SHEN, MD PhD, GCP office

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Anticipated): September 1, 2020
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: July 29, 2017
• First Submitted That Met QC Criteria: July 29, 2017
• First Posted (Actual): August 2, 2017

Study Record Updates

• Last Update Posted (Actual): August 9, 2019
• Last Update Submitted That Met QC Criteria: August 7, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia
• Other Study ID Numbers: VOMAS-C

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No