Validating and Optimizing Model of Antipsychotics Selection

Shanghai Mental Health Center

Status: Unknown

Conditions: Schizophrenia

Treatments: Other: non-model; Other: model

Study type: Interventional

Funder types: Other

Identifiers

NCT03237052

VOMAS-C

Details and patient eligibility

About

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.

Enrollment: 2,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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2,000 participants in 2 patient groups

model

Experimental group

Description:

model aided decision

Treatment:

Other: model

non-model

Active Comparator group

Description:

real-world psychiatrist decision

Treatment:

Other: non-model