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出境医 / 临床实验 / Prolactin Change in Chinese Patients With Schizophrenia After Antipsychotics Treatment

Prolactin Change in Chinese Patients With Schizophrenia After Antipsychotics Treatment

Study Description
Brief Summary:

Objective:

Hyperprolactinemia(HPRL) which can result in a series of prolactin-related symptoms is a frequent adverse effect of antipsychotics. The investigators are interested to explicate the characteristics of serum prolactin level change after taking different antipsychotics and related factors.

Method:

  1. Review of electronic medical records of schizophrenia patients who were brought to Shanghai Mental Health Center since January 1, 2007.

  2. The investigators collect their information, and then

    1. set serum prolactin level after first 1-month antipsychotic treatment as primary outcome. Secondary outcomes are prolactin levels tested at other time points.
    2. Variables will range from antipsychotic kinds, dosage, treatment duration and blood concentration to demographic information, to disease history, to clinical treatment on hyperprolactinemia, to laboratory test results, such as blood routine examination, biochemistry, sex hormone levels and so on.

    3. After data cleaning and management, we will apply logistic regression, cox regression, Receiver Operating Characteristic curve (ROC) and machine learning to

      • analyze factors of prolactin level;
      • establish a model of prolactin change with time;
      • propose optimal monitoring time of prolactin according to prolactin change with time;
      • analyze correlation among antipsychotics, prolactin and clinical characters, for the purpose to supply objective evidence for antipsychotic treatment.

Condition or disease Intervention/treatment
Schizophrenia Antipyretics Toxicity Prolactin Excess Drug: Antipsychotic

Study Design
Layout table for study information
Study Type : Observational
Estimated Enrollment : 10000 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Prolactin Change and Its Effectors in Chinese Patients With Schizophrenia After Antipsychotics Treatment
Actual Study Start Date : June 6, 2019
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : December 2020
Arms and Interventions
Outcome Measures
Primary Outcome Measures :
  1. prolactin level at first 1-month antipsychotic treatment [ Time Frame: at first 1-month antipsychotic treatment ]
    Serum prolactin level may change significantly after one month antipsychotic treatment.


Secondary Outcome Measures :
  1. prolactin level at other time points [ Time Frame: after 2-month, 3-month and half a year treatment with antipsychotics ]
    Different patients have different tendencies of prolactin, so collecting prolactin level at different time after exposed to antipsychotics is necessary.


Eligibility Criteria
Contacts and Locations
Tracking Information
First Submitted Date March 26, 2019
First Posted Date June 28, 2019
Last Update Posted Date January 2, 2020
Actual Study Start Date June 6, 2019
Estimated Primary Completion Date November 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 26, 2019) 		prolactin level at first 1-month antipsychotic treatment [ Time Frame: at first 1-month antipsychotic treatment ]
Serum prolactin level may change significantly after one month antipsychotic treatment.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: June 26, 2019) 		prolactin level at other time points [ Time Frame: after 2-month, 3-month and half a year treatment with antipsychotics ]
Different patients have different tendencies of prolactin, so collecting prolactin level at different time after exposed to antipsychotics is necessary.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Prolactin Change in Chinese Patients With Schizophrenia After Antipsychotics Treatment
Official Title Prolactin Change and Its Effectors in Chinese Patients With Schizophrenia After Antipsychotics Treatment
Brief Summary

Objective:

Hyperprolactinemia(HPRL) which can result in a series of prolactin-related symptoms is a frequent adverse effect of antipsychotics. The investigators are interested to explicate the characteristics of serum prolactin level change after taking different antipsychotics and related factors.

Method:

  1. Review of electronic medical records of schizophrenia patients who were brought to Shanghai Mental Health Center since January 1, 2007.

  2. The investigators collect their information, and then

    1. set serum prolactin level after first 1-month antipsychotic treatment as primary outcome. Secondary outcomes are prolactin levels tested at other time points.
    2. Variables will range from antipsychotic kinds, dosage, treatment duration and blood concentration to demographic information, to disease history, to clinical treatment on hyperprolactinemia, to laboratory test results, such as blood routine examination, biochemistry, sex hormone levels and so on.

    3. After data cleaning and management, we will apply logistic regression, cox regression, Receiver Operating Characteristic curve (ROC) and machine learning to

      • analyze factors of prolactin level;
      • establish a model of prolactin change with time;
      • propose optimal monitoring time of prolactin according to prolactin change with time;
      • analyze correlation among antipsychotics, prolactin and clinical characters, for the purpose to supply objective evidence for antipsychotic treatment.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population patients with schizophrenia who were taking or going to take antipsychotic medicine.
Condition
  • Schizophrenia
  • Antipyretics Toxicity
  • Prolactin Excess
Intervention Drug: Antipsychotic
any antipsychotic medicine that would have the effect on prolactin level, such as amisulpride, risperidone, olanzapine and so on.
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Estimated Enrollment
 (submitted: June 26, 2019) 		10000
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2020
Estimated Primary Completion Date November 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • diagnosed as schizophrenia according to Diagnostic and Statistical Manual of Mental Disorders(DSM)-5;
  • were taking or going to take antipsychotics;
  • have the results of serum prolactin level.

Exclusion Criteria:

  • other mental disorder;
  • suffered endocrinic diseases of pituitary or thyroid gland;
  • suffered other organic brain diseases;
  • have the history of tobacco or alcohol abuse, or psychoactive drug substance abuse.
Sex/Gender
Sexes Eligible for Study: All
Ages 14 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT04002258
Other Study ID Numbers CRC2018DSJ01-2
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party LI, Huafang, Shanghai Mental Health Center
Study Sponsor Shanghai Mental Health Center
Collaborators Not Provided
Investigators
Principal Investigator: Huafang Li, MD, PhD Shanghai Mental Health Center
PRS Account Shanghai Mental Health Center
Verification Date December 2019

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