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Completed

NCT Number: NCT04002258

Prolactin Change in Chinese Patients With Schizophrenia After Antipsychotics Treatment

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.

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Key information

Age range

14 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, 200030, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Antipsychotic

Drug

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Shanghai Mental Health Center

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Jun 28, 2019
Registry last updated
Oct 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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