Prolactin Change in Chinese Patients With Schizophrenia After Antipsychotics Treatment

Completed

• Conditions: Schizophrenia; Antipyretics Toxicity; Prolactin Excess

• Registration Number: NCT04002258
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-03-26
• Study Start: 2019-06-06
• Study First Submitted QC: 2019-06-26
• Study First Posted: 2019-06-28
• Status Verified: 2022-10
• Primary Completion: 2022-10-01
• Study Completion: 2022-10-25
• Last Update Submitted: 2022-10-26
• Last Update Posted: 2022-10-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10363

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
prolactin level at first 1-month antipsychotic treatment	at first 1-month antipsychotic treatment	Serum prolactin level may change significantly after one month antipsychotic treatment.

Secondary Outcome Measures

Name	Time	Method
prolactin level at other time points	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.

Trial Locations

Locations (1)

Shanghai Mental Health Center; 🇨🇳 Shanghai, Shanghai, China