Prolactin Change in Chinese Patients With Schizophrenia After Antipsychotics Treatment

Prolactin Change and Its Effectors 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.

Study Overview

• Status: Completed
• Conditions: Schizophrenia; Antipyretics Toxicity; Prolactin Excess
• Intervention / Treatment: Drug: Antipsychotic

• Study Type: Observational
• Enrollment (Actual): 10363

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200030
      • Shanghai Mental Health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients with schizophrenia who were taking or going to take antipsychotic medicine.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
prolactin level at first 1-month antipsychotic treatment	Serum prolactin level may change significantly after one month antipsychotic treatment.	at first 1-month antipsychotic treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
prolactin level at other time points	Different patients have different tendencies of prolactin, so collecting prolactin level at different time after exposed to antipsychotics is necessary.	after 2-month, 3-month and half a year treatment with antipsychotics

Collaborators and Investigators

• Sponsor: Shanghai Mental Health Center
• Investigators: Principal Investigator: Huafang LI, MD, PHD, Shanghai Mental Health Center

Study record dates

Study Major Dates

• Study Start (Actual): June 6, 2019
• Primary Completion (Actual): October 1, 2022
• Study Completion (Actual): October 25, 2022

Study Registration Dates

• First Submitted: March 26, 2019
• First Submitted That Met QC Criteria: June 26, 2019
• First Posted (Actual): June 28, 2019

Study Record Updates

• Last Update Posted (Actual): October 27, 2022
• Last Update Submitted That Met QC Criteria: October 26, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Physiological Effects of Drugs; Central Nervous System Depressants; Tranquilizing Agents; Psychotropic Drugs; Antipsychotic Agents
• Other Study ID Numbers: CRC2018DSJ01-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes