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Validating and Optimizing Model of Antipsychotics Selection

Primary Purpose

Schizophrenia

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
model
non-model
Sponsored by
Shanghai Mental Health Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Shanghai Mental Health CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

model

non-model

Arm Description

model aided decision

real-world psychiatrist decision

Outcomes

Primary Outcome Measures

Change of PSP from Baseline
PSP assessment at 52 weeks

Secondary Outcome Measures

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

Full Information

First Posted
July 29, 2017
Last Updated
August 7, 2019
Sponsor
Shanghai Mental Health Center
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1. Study Identification

Unique Protocol Identification Number
NCT03237052
Brief Title
Validating and Optimizing Model of Antipsychotics Selection
Official Title
A Randomized Controlled Multi-center Clinical Study Focusing on Validating and Optimizing Model of Antipsychotics Selection in China
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
September 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Mental Health Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
2000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
model
Arm Type
Experimental
Arm Description
model aided decision
Arm Title
non-model
Arm Type
Active Comparator
Arm Description
real-world psychiatrist decision
Intervention Type
Other
Intervention Name(s)
model
Other Intervention Name(s)
model aided decision
Intervention Description
a model that has been established in advance.
Intervention Type
Other
Intervention Name(s)
non-model
Other Intervention Name(s)
non-model decision
Intervention Description
real-world psychiatrist decision
Primary Outcome Measure Information:
Title
Change of PSP from Baseline
Description
PSP assessment at 52 weeks
Time Frame
52 weeks
Secondary Outcome Measure Information:
Title
Change of PANSS from Baseline
Description
PANSS assessment at 52 weeks
Time Frame
52 weeks
Title
Change of CDSS from Baseline
Description
CDSS assessment at 52 weeks
Time Frame
52 weeks
Title
Change of CGI from Baseline
Description
CGI assessment at 52 weeks
Time Frame
52 weeks
Title
Change of liver function from Baseline
Description
Liver function assessment at 52 weeks
Time Frame
52 weeks
Title
Change of PRL from Baseline
Description
PRL assessment at 52 weeks
Time Frame
52 weeks
Title
Number of Participants with EPS
Description
EPS assessment at 52 weeks
Time Frame
52 weeks
Title
Number of Participants with abnormal ECG
Description
ECG assessment at 52 weeks
Time Frame
52 weeks
Title
Number of Participants with abnormal sexual function
Description
sexual function assessment at 52 weeks
Time Frame
52 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yifeng SHEN, MD PhD
Phone
86-21-34773657
Email
shenyifeng@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yifeng SHEN, MD PhD
Organizational Affiliation
GCP Office
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai Mental Health Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200030
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yifeng SHEN, MD
Phone
+862134773657

12. IPD Sharing Statement

Plan to Share IPD
No

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Validating and Optimizing Model of Antipsychotics Selection

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