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Atypical Antipsychotics Influence on the Safety of the Heart and Monitoring Indicators Model Building

Primary Purpose

Schizophrenia

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Risperidone
Aripiprazole
Ziprasidone
Amisulpride
Quetiapine
Sponsored by
Shanghai Mental Health Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Atypical antipsychotics, Cardiac safety, Model building

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Phase one:Effects of different types of atypical antipsychotics on cardiac safety.

    1. Meet the diagnostic of "schizophrenia" according to DSM-IV and fail to take medication in the first episode or stop taking medication for more than 2 weeks
    2. Han ethnic, 18-45 years old;
    3. Exclude persons with mental disorders caused by organic diseases, drugs or alcohol, and other mental disorders, and serious suicide attempts.
    4. Willing to participate in the trial and receive treatment;
    5. Course of disease within 2 years;
    6. Able to communicate effectively with the researcher and complete the written informed consent signed by hand.

Phase two:Construction of cardiac safety monitoring model

  1. Meet the diagnostic of "schizophrenia" according to DSM-IV and fail to take medication in the first episode or stop taking medication for more than 2 weeks
  2. Han ethnic, 18-45 years old;
  3. Exclude persons with mental disorders caused by organic diseases, drugs or alcohol, and other mental disorders, and serious suicide attempts.
  4. Willing to participate in the trial and receive treatment;
  5. Serious arrhythmia, myocarditis, cardiomyopathy and cardiac insufficiency during taking medicine;
  6. Able to communicate effectively with the researcher and complete the written informed consent signed by hand.

Exclusion Criteria:

  • (1) Participating in other clinical studies; (2) Combination of DSM-IV diagnoses other than schizophrenia; (3) History of heart disease; (4) History of drug abuse in the previous 6 months; (5) Pregnant or in the first three months of lactation; (6) Combination of antipsychotics, mood stabilizers and antidepressants was used in the study.

Sites / Locations

  • CHINA

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Risperidone

Aripiprazole

Ziprasidone

Amisulpride

Quetiapine

Arm Description

Risperidone tablet

Aripiprazole tablet

Ziprasidone tablet

Amisulpride tablet

Quetiapine tablet

Outcomes

Primary Outcome Measures

Cardiac QTc(corrected QT interval) interphase changes after drug administration.
Cardiac QTc interphase changes during the study duration

Secondary Outcome Measures

Biochemical index: BNP(Brain Natriuretic Peptide)
Changes of biochemical indexes during the study duration
Biochemical index:troponin
Changes of biochemical indexes during the study duration
Biochemical index: myoglobin
Changes of biochemical indexes during the study duration
Electrocardiogram:Heart rate
Changes of ECG indicators during the study duration
Echocardiographic: EF(Ejection Fraction) value
Changes of cardiac ultrasound indicators during the study duration

Full Information

First Posted
June 22, 2020
Last Updated
August 25, 2020
Sponsor
Shanghai Mental Health Center
Collaborators
Shanghai Jiao Tong University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT04446234
Brief Title
Atypical Antipsychotics Influence on the Safety of the Heart and Monitoring Indicators Model Building
Official Title
Atypical Antipsychotics Influence on the Safety of the Heart and Monitoring Indicators Model Building
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
May 2021 (Anticipated)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Mental Health Center
Collaborators
Shanghai Jiao Tong University School of Medicine

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
The purpose of this study was to investigate the effect of atypical antipsychotics on cardiac safety. The secondary purpose was to understand the rate of QTc prolongation in electrocardiogram induced by atypical antipsychotics. And try to construct the model of cardiac monitoring index. We conducted a randomized trial in which patients with schizophrenia who were first on or off medication for more than two weeks took a single atypical antipsychotic (Risperidone, Aripiprazole, Ziprasidone, Amisulpride, Quetiapine) for 12 weeks and monitored changes in biochemical, electrocardiogram and other indicators. And then 50 patients with adverse cardiac reactions (ADRs) taking antipsychotics were selected to review the data, analyze and construct a monitoring model. We hypothesized that atypical antipsychotics with different mechanisms of action have different effects on cardiac safety in patients with schizophrenia, and that they are applicable to different populations. The monitoring index model can reduce the occurrence of cardiotoxicity and improve the prognosis.
Detailed Description
Atypical antipsychotics, also known as new antipsychotics, are a group of drugs that act on the central nervous system to treat schizophrenia, psychotic disorder or bipolar disorder. Compared with typical antipsychotics, atypical antipsychotics have the advantages of good efficacy and fewer side effects. Therefore, currently, atypical antipsychotics are widely used in clinical practice. In recent years, the effects of atypical antipsychotics on metabolism and cardiovascular system have attracted more and more clinical attention. Studies have found that long-term use of atypical antipsychotics can lead to arrhythmias, drug-induced myocarditis, and even cardiac arrest. Since antipsychotics can cause cardiac adverse events in patients with schizophrenia, accompanied by medical complications, resulting in a generally shorter life span of 15-25 years compared with the general population, cardiac safety assessment of drugs for patients with schizophrenia is becoming increasingly important. But the domestic study of antipsychotics in the cardiovascular field, especially about the safety of heart systemic evaluation are few and far between, so this research has focused on patients with schizophrenia in China people use different mechanisms of atypical antipsychotics (Risperidone, Aripiprazole, Ziprasidone, Amisulpride, Quetiapine) on heart safety. In the first stage, a total of 350 schizophrenia patients were enrolled who were either not on medication for the first time or stopped for more than 2 weeks. They were treated with atypical antipsychotics respectively, follow-up of 12 weeks, evaluating the effects of antipsychotics on cardiac function and structure in patients with schizophrenia from general data, biochemistry, electrocardiogram, etc. In the second stage, 50 patients of adverse cardiac reactions caused by taking antipsychotics were selected from enrolled subjects, and a retrospective analysis(day1, week4, week12, and week24) was conducted to try to build a cardiac safety detection indicator model, so as to understand the impact of antipsychotics on cardiac safety. More rational use of antipsychotics in the context of ensuring clinical efficacy and minimum side effects, and the use of monitoring indicator models to reduce the occurrence of cardiac toxicity, improve the safety of antipsychotics in use.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Atypical antipsychotics, Cardiac safety, Model building

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
350 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Risperidone
Arm Type
Experimental
Arm Description
Risperidone tablet
Arm Title
Aripiprazole
Arm Type
Experimental
Arm Description
Aripiprazole tablet
Arm Title
Ziprasidone
Arm Type
Experimental
Arm Description
Ziprasidone tablet
Arm Title
Amisulpride
Arm Type
Experimental
Arm Description
Amisulpride tablet
Arm Title
Quetiapine
Arm Type
Experimental
Arm Description
Quetiapine tablet
Intervention Type
Drug
Intervention Name(s)
Risperidone
Intervention Description
Use medicine according to patients condition
Intervention Type
Drug
Intervention Name(s)
Aripiprazole
Intervention Description
Use medicine according to patients condition
Intervention Type
Drug
Intervention Name(s)
Ziprasidone
Intervention Description
Use medicine according to patients condition
Intervention Type
Drug
Intervention Name(s)
Amisulpride
Intervention Description
Use medicine according to patients condition
Intervention Type
Drug
Intervention Name(s)
Quetiapine
Intervention Description
Use medicine according to patients condition
Primary Outcome Measure Information:
Title
Cardiac QTc(corrected QT interval) interphase changes after drug administration.
Description
Cardiac QTc interphase changes during the study duration
Time Frame
baseline, week2,4, 8, 12,24
Secondary Outcome Measure Information:
Title
Biochemical index: BNP(Brain Natriuretic Peptide)
Description
Changes of biochemical indexes during the study duration
Time Frame
baseline, week2,4, 8, 12,24
Title
Biochemical index:troponin
Description
Changes of biochemical indexes during the study duration
Time Frame
baseline, week2,4, 8, 12,24
Title
Biochemical index: myoglobin
Description
Changes of biochemical indexes during the study duration
Time Frame
baseline, week2,4, 8, 12,24
Title
Electrocardiogram:Heart rate
Description
Changes of ECG indicators during the study duration
Time Frame
baseline, week2,4, 8, 12,24
Title
Echocardiographic: EF(Ejection Fraction) value
Description
Changes of cardiac ultrasound indicators during the study duration
Time Frame
baseline, week2,4, 8, 12,24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Phase one:Effects of different types of atypical antipsychotics on cardiac safety. Meet the diagnostic of "schizophrenia" according to DSM-IV and fail to take medication in the first episode or stop taking medication for more than 2 weeks Han ethnic, 18-45 years old; Exclude persons with mental disorders caused by organic diseases, drugs or alcohol, and other mental disorders, and serious suicide attempts. Willing to participate in the trial and receive treatment; Course of disease within 2 years; Able to communicate effectively with the researcher and complete the written informed consent signed by hand. Phase two:Construction of cardiac safety monitoring model Meet the diagnostic of "schizophrenia" according to DSM-IV and fail to take medication in the first episode or stop taking medication for more than 2 weeks Han ethnic, 18-45 years old; Exclude persons with mental disorders caused by organic diseases, drugs or alcohol, and other mental disorders, and serious suicide attempts. Willing to participate in the trial and receive treatment; Serious arrhythmia, myocarditis, cardiomyopathy and cardiac insufficiency during taking medicine; Able to communicate effectively with the researcher and complete the written informed consent signed by hand. Exclusion Criteria: (1) Participating in other clinical studies; (2) Combination of DSM-IV diagnoses other than schizophrenia; (3) History of heart disease; (4) History of drug abuse in the previous 6 months; (5) Pregnant or in the first three months of lactation; (6) Combination of antipsychotics, mood stabilizers and antidepressants was used in the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
LV QINYU
Phone
18017311158
Email
18616550357@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
YI ZHENGHUI
Phone
18017311007
Email
yizhenghui1971@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
LV QINYU
Organizational Affiliation
SHANGHAI MENTAL HEALTH CENTRE
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHINA
City
Shanghai
State/Province
Minhang
ZIP/Postal Code
201108
Country
China

12. IPD Sharing Statement

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Atypical Antipsychotics Influence on the Safety of the Heart and Monitoring Indicators Model Building

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