Clinical trial NCT04002258: Prolactin Change in Chinese Patients With Schizophrenia After Antipsychotics Treatment
Official title: Prolactin Change and Its Effectors in Chinese Patients With Schizophrenia After Antipsychotics Treatment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Schizophrenia
Antipyretics Toxicity
Prolactin Excess
Lead sponsor: Shanghai Mental Health Center
Sponsor class: OTHER
First posted: 2019-06-28
Enrollment: 10363
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with schizophrenia who were taking or going to take antipsychotic medicine.

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.


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.

Primary outcomes:
measure: prolactin level at first 1-month antipsychotic treatment
timeFrame: at first 1-month antipsychotic treatment
Secondary outcomes:
measure: prolactin level at other time points
timeFrame: after 2-month, 3-month and half a year treatment with antipsychotics
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Mental Health Center
state: Shanghai
Study officials:
affiliation: Shanghai Mental Health Center
name: Huafang Li, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: