NCT04002258

Prolactin Change in Chinese Patients With Schizophrenia After Antipsychotics Treatment

Prolactin Change and Its Effectors in Chinese Patients With Schizophrenia After Antipsychotics Treatment

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 10,363 (actual)
• Sponsor: Shanghai Mental Health Center · Academic / Other
• Sex: All
• Age: 14 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Schizophrenia
• Antipyretics Toxicity
• Prolactin Excess

Interventions

Type	Name	Description
DRUG	Antipsychotic	any antipsychotic medicine that would have the effect on prolactin level, such as amisulpride, risperidone, olanzapine and so on.

Timeline

• Start date: 2019-06-06
• Primary completion: 2022-10-01
• Completion: 2022-10-25
• First posted: 2019-06-28
• Last updated: 2022-10-27

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study