Prolactin Change in Chinese Patients With Schizophrenia After Antipsychotics Treatment

NCT04002258 | Completed FDA Drug

• 1 other identifier: CRC2018DSJ01-2
• Study Type: observational
• Target: 10,363
• Locations: 1 country
• Sites: 1

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:

• 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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• prolactin level at other time points

  after 2-month, 3-month and half a year treatment with antipsychotics

Interventions

Antipsychotic DRUG

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

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Mental Health Center: lead

Study Sites (1)

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, 200030, China

Location

Related Publications (1)

• 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 Dec;39(12):1317-1330. doi: 10.1007/s40263-025-01216-1. Epub 2025 Aug 19.

  PMID: 40830714 DERIVED

MeSH Terms

Conditions

Schizophrenia; Hyperprolactinemia

Interventions

Antipsychotic Agents

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Hyperpituitarism; Pituitary Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Tranquilizing Agents; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Central Nervous System Agents; Therapeutic Uses; Psychotropic Drugs

Study Officials

• Huafang Li, MD, PhD

  Shanghai Mental Health Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director and Clinical Professor

Study Record Dates

• First Submitted: March 26, 2019
• First Posted: June 28, 2019
• Study Start: June 6, 2019
• Primary Completion: October 1, 2022
• Study Completion: October 25, 2022
• Last Updated: October 27, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)