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Prolactin Change in Chinese Patients With Schizophrenia After Antipsychotics Treatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04002258
Recruitment Status : Active, not recruiting
First Posted : June 28, 2019
Last Update Posted : January 2, 2020
Sponsor:
Information provided by (Responsible Party):
LI, Huafang, Shanghai Mental Health Center

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

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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

Resource links provided by the National Library of Medicine

Drug Information available for: Prolactin


Intervention Details:
  • Drug: Antipsychotic
    any antipsychotic medicine that would have the effect on prolactin level, such as amisulpride, risperidone, olanzapine and so on.


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.



Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients with schizophrenia who were taking or going to take antipsychotic medicine.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04002258


Locations
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China, Shanghai
Shanghai Mental Health Center
Shanghai, Shanghai, China, 200030
Sponsors and Collaborators
Shanghai Mental Health Center
Investigators
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Principal Investigator: Huafang Li, MD, PhD Shanghai Mental Health Center
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Responsible Party: LI, Huafang, Director and Clinical Professor, Shanghai Mental Health Center
ClinicalTrials.gov Identifier: NCT04002258    
Other Study ID Numbers: CRC2018DSJ01-2
First Posted: June 28, 2019    Key Record Dates
Last Update Posted: January 2, 2020
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs