Validating and Optimizing Model of Antipsychotics Selection

NCT03237052 | Unknown

• 1 other identifier: VOMAS-C
• Study Type: interventional
• Target: 2,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (1)

• Change of PSP from Baseline

  PSP assessment at 52 weeks

  52 weeks

Secondary Outcomes (8)

• Change of PANSS from Baseline

  52 weeks

• Change of CDSS from Baseline

  52 weeks

• Change of CGI from Baseline

  52 weeks

• Change of liver function from Baseline

  52 weeks

• Change of PRL from Baseline

  52 weeks

Study Arms (2)

model

EXPERIMENTAL

model aided decision

Other: model

non-model

ACTIVE COMPARATOR

real-world psychiatrist decision

Other: non-model

Interventions

model OTHER

a model that has been established in advance.

Also known as: model aided decision

model

non-model OTHER

real-world psychiatrist decision

Also known as: non-model decision

non-model

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Mental Health Center: lead

Study Sites (1)

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, 200030, China

RECRUITING

MeSH Terms

Conditions

Schizophrenia

Interventions

Models, Biological; Nonlinear Dynamics

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Models, Theoretical; Investigative Techniques

Study Officials

• Yifeng SHEN, MD PhD

  GCP Office

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yifeng SHEN, MD PhD

CONTACT

86-21-34773657; shenyifeng@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2017
• First Posted: August 2, 2017
• Study Start: January 1, 2018
• Primary Completion: September 1, 2020
• Study Completion: December 1, 2020
• Last Updated: August 9, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)