Prolactin Change in Chinese Patients With Schizophrenia After Antipsychotics Treatment

NCT ID: NCT04002258

Last Updated: 2022-10-27

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 10363 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-06-06
• Study Completion Date: 2022-10-25

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.

Conditions

Schizophrenia; Antipyretics Toxicity; Prolactin Excess

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Interventions

Antipsychotic

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

Intervention Type: DRUG

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.

• Minimum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Mental Health Center

OTHER

Sponsor Role: lead

Responsible Party

LI, Huafang

Director and Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Huafang Li, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Shanghai Mental Health Center

Locations

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, China

Countries

China

References

Zhang L, Zheng Y, Huang J, Yu W, Zhou L, He L, Li Y, Hu H, Li G, Shen Y, Zhang J, Li H. Patterns of Serum Prolactin Elevation Associated with Nine Second-Generation Antipsychotics in a Large Cohort of Patients with Schizophrenia. CNS Drugs. 2025 Aug 19. doi: 10.1007/s40263-025-01216-1. Online ahead of print.

Reference Type: DERIVED

PMID: 40830714 (View on PubMed)

Other Identifiers

CRC2018DSJ01-2

Identifier Type: -

Identifier Source: org_study_id