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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04002258
Enrollment
10363
Registered
2019-06-28
Start date
2019-06-06
Completion date
2022-10-25
Last updated
2022-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia, Antipyretics Toxicity, Prolactin Excess

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.

Interventions

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

Sponsors

Shanghai Mental Health Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
14 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
prolactin level at first 1-month antipsychotic treatmentat first 1-month antipsychotic treatmentSerum prolactin level may change significantly after one month antipsychotic treatment.

Secondary

MeasureTime frameDescription
prolactin level at other time pointsafter 2-month, 3-month and half a year treatment with antipsychoticsDifferent patients have different tendencies of prolactin, so collecting prolactin level at different time after exposed to antipsychotics is necessary.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026