Validating and Optimizing Model of Antipsychotics Selection

NCT ID: NCT03237052

Last Updated: 2019-08-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 2000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-01
• Study Completion Date: 2020-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

model

model aided decision

Group Type: EXPERIMENTAL

model

Intervention Type: OTHER

a model that has been established in advance.

non-model

real-world psychiatrist decision

Group Type: ACTIVE_COMPARATOR

non-model

Intervention Type: OTHER

real-world psychiatrist decision

Interventions

model

a model that has been established in advance.

Intervention Type: OTHER

non-model

real-world psychiatrist decision

Intervention Type: OTHER

Other Intervention Names

model aided decision; non-model decision

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Mental Health Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yifeng SHEN, MD PhD

Role: PRINCIPAL_INVESTIGATOR

GCP Office

Locations

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yifeng SHEN, MD PhD

Role: CONTACT

shenyifeng@yahoo.com

86-21-34773657

Facility Contacts

Yifeng SHEN, MD

Role: primary

+862134773657

Other Identifiers

VOMAS-C

Identifier Type: -

Identifier Source: org_study_id