SchizophreniaNCT04002258
Prolactin Change in Chinese Patients With Schizophrenia After Antipsychotics Treatment
An observational study of Schizophrenia and Antipyretics Toxicity, run by Shanghai Mental Health Center at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Schizophrenia, Antipyretics Toxicity, Prolactin Excess
- What is being tested?
- Antipsychotic
- How many people
- 10,363 participants
- Where
- 1 siteChina
- Study dates
- 6 Jun 2019to 25 Oct 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients with schizophrenia who were taking or going to take antipsychotic medicine.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, 200030
About this study
Official title: 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.
Read more
Method:
- Review of electronic medical records of schizophrenia patients who were brought to Shanghai Mental Health Center since January 1, 2007.
- The investigators collect their information, and then
- set serum prolactin level after first 1-month antipsychotic treatment as primary outcome. Secondary outcomes are prolactin levels tested at other time points.
- 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.
- 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.
- Conditions
- Schizophrenia, Antipyretics Toxicity, Prolactin Excess
- Being tested
- Antipsychotic
- Medical subject headings
- Schizophrenia, Hyperprolactinemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AntipsychoticDrug
any antipsychotic medicine that would have the effect on prolactin level, such as amisulpride, risperidone, olanzapine and so on.
What is being measured
The primary outcome is the main question the study is designed to answer.
prolactin level at first 1-month antipsychotic treatment
Serum prolactin level may change significantly after one month antipsychotic treatment.
Measured: at first 1-month antipsychotic treatment
Secondary outcomes (1)
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.
Measured: after 2-month, 3-month and half a year treatment with antipsychotics
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2019
- Study start6 Jun 2019
- Primary completion1 Oct 2022
- Study completion25 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Shanghai Mental Health CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 10,363 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Mental Health Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, LI, Huafang, Shanghai Mental Health Center
- Investigators
- Huafang Li, MD, PhD, Principal investigator, Shanghai Mental Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04002258
- Sponsor's protocol ID
- CRC2018DSJ01-2
- Status last verified
- Oct 2022
- First submitted
- 26 Mar 2019
- Last updated
- 27 Oct 2022
- Results posted
- No
- FDA-regulated drug
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 40830714
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prolactin Change and Its Effectors in Chinese Patients With Schizophrenia After Antipsychotics Treatment
- ClinicalTrials.gov ID
- NCT04002258
- Acronym / sponsor ID
- CRC2018DSJ01-2
- Conditions
- Schizophrenia, Antipyretics Toxicity, Prolactin Excess
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10,363 participants (actual)
- Lead sponsor
- Shanghai Mental Health CenterUniversity, hospital or other
- Study start
- 6 Jun 2019 (actual)
- Primary completion
- 1 Oct 2022 (actual)
- Study completion
- 25 Oct 2022 (actual)
- First posted
- 28 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Review of electronic medical records of schizophrenia patients who were brought to Shanghai Mental Health Center since January 1, 2007.
- The investigators collect their information, and then
- set serum prolactin level after first 1-month antipsychotic treatment as primary outcome. Secondary outcomes are prolactin levels tested at other time points.
- 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.
- 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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients with schizophrenia who were taking or going to take antipsychotic medicine.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Antipsychoticany antipsychotic medicine that would have the effect on prolactin level, such as amisulpride, risperidone, olanzapine and so on. | Drug | – |
Primary outcome
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.
1 secondary outcome
prolactin level at other time points
Time frame: after 2-month, 3-month and half a year treatment with antipsychotics
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2022.
- Derived from this study: PubMed 40830714Zhang 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Huafang Li, MD, PhD principal investigator
Shanghai Mental Health Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Schizophrenia and Antipyretics Toxicity, run by Shanghai Mental Health Center at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prolactin level at first 1-month antipsychotic treatment (time frame: at first 1-month antipsychotic treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04002258, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2022.