Prolactin Change in Chinese Patients With Schizophrenia After Antipsychotics Treatment
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|ClinicalTrials.gov Identifier: NCT04002258|
Recruitment Status : Active, not recruiting
First Posted : June 28, 2019
Last Update Posted : January 2, 2020
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.
- Review of electronic medical records of schizophrenia patients who were brought to Shanghai Mental Health Center since January 1, 2007.
The investigators collect their information, and then
- set serum prolactin level after first 1-month antipsychotic treatment as primary outcome. Secondary outcomes are prolactin levels tested at other time points.
- 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.
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 Type :||Observational|
|Estimated Enrollment :||10000 participants|
|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|
- Drug: Antipsychotic
any antipsychotic medicine that would have the effect on prolactin level, such as amisulpride, risperidone, olanzapine and so on.
- 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.
- 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.
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
|Shanghai Mental Health Center|
|Shanghai, Shanghai, China, 200030|
|Principal Investigator:||Huafang Li, MD, PhD||Shanghai Mental Health Center|