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ArticleCNS drugs2025

Patterns of Serum Prolactin Elevation Associated with Nine Second-Generation Antipsychotics in a Large Cohort of Patients with Schizophrenia.

Lei Zhang, Yuzhen Zheng, Jingjing Huang, Wenjuan Yu, Lihong Zhou, Luyao He, Yange Li, Hao Hu, Guanjun Li, Yifeng Shen and 2 more

Registry-linked trialAbstract read
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Article in CNS drugs, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04002258 (Prolactin Change and Its Effectors in Chinese Patients With Schizophrenia After Antipsychotics Treatment), which is not on this map. Not yet cited in PubMed.

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0cells of the map it votes in
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1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04002258 completednot on this map

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

TypeobservationalSponsorShanghai Mental Health CenterRan2019 to 2022Enrolled10,363ConditionsSchizophrenia, Antipyretics Toxicity, Prolactin ExcessArmsAntipsychotic
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors.

Lei ZhangDepartment of Psychiatry, Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, No.600 Wan Ping South Road, Shanghai, 200030, China.
Yuzhen ZhengDepartment of Psychiatry, Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, No.600 Wan Ping South Road, Shanghai, 200030, China.
Jingjing HuangShanghai Pudong New Area Mental Health Center, Mental Health Center Affiliated to Tongji University, Shanghai, China.
Wenjuan YuDepartment of Psychiatry, Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, No.600 Wan Ping South Road, Shanghai, 200030, China.
Lihong ZhouDepartment of Psychiatry, Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, No.600 Wan Ping South Road, Shanghai, 200030, China.
Luyao HeDepartment of Psychiatry, Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, No.600 Wan Ping South Road, Shanghai, 200030, China.
Yange LiDepartment of Psychiatry, First Affiliated Hospital of Zhengzhou University, Zhengzhou, China.
Hao HuDepartment of Psychiatry, Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, No.600 Wan Ping South Road, Shanghai, 200030, China.
Guanjun LiDepartment of Psychiatry, Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, No.600 Wan Ping South Road, Shanghai, 200030, China.
Yifeng ShenDepartment of Psychiatry, Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, No.600 Wan Ping South Road, Shanghai, 200030, China.
Jianping ZhangDepartment of Psychiatry, Weill Cornell Medical College, New York-Presbyterian Hospital Westchester Behavioral Health Center, 21 Bloomingdale Rd, White Plains, NY, 10605, USA. jaz9035@med.cornell.edu.
Huafang LiDepartment of Psychiatry, Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, No.600 Wan Ping South Road, Shanghai, 200030, China. lihuafang@smhc.org.cn.ORCID 0000-0002-4357-7614

Funding

Collaborative Innovation Center for Clinical and Translational Science by Ministry of Education & Shanghai CCTS-202306Collaborative Innovation Center for Clinical and Translational Science by Ministry of Education & Shanghai CCTS-202409PTFundamental Research Funds for the Central Universities YG2023QNA44Shanghai Clinical Research Center for Mental Health 19MC1911100Shanghai Municipal Health Commission 20224Y0269
6 · The paper itself

Abstract

backgroundProlactin elevation associated with antipsychotic use significantly affects medication adherence and long-term treatment outcomes in patients with schizophrenia. The currently available data are insufficient to guide the monitoring and management of elevated prolactin levels in patients on antipsychotic medications. This study aimed to explore the patterns of prolactin level elevation associated with nine second-generation antipsychotics (SGAs) in a real-world setting and compare the associated risks.

methodsThis retrospective cohort study utilized data from the inpatient electronic medical records of a large mental health center in China from 2007 to 2019. The study included patients diagnosed with schizophrenia (ICD-10 criteria) who received SGA therapy and whose serum prolactin levels were measured. Exposures were the use of nine specific SGAs (amisulpride, risperidone, paliperidone, ziprasidone, olanzapine, perospirone, quetiapine, clozapine, or aripiprazole), including polytherapy and monotherapy. The primary outcome was incident prolactin elevation in patients during hospitalization. An adjusted stratified Cox proportional hazards regression analysis was used to compare the hazard ratios (HRs) of prolactin level elevation across the nine SGAs. In addition, a dose-response analysis of these SGAs was conducted using the defined daily dose (DDD) method. Dose categories were as follows: < 0.6 DDDs/day (low dose), 0.6 to < 1.1 DDDs/day (medium dose), and ≥ 1.1 DDDs/day (high dose).

resultsThis study included 6489 patients with schizophrenia (mean [SD] age, 35.1 [14.2] years; 3396 males [52.3%]). Compared with the nonexposure, amisulpride (HR 2.76, 95% confidence interval [CI] 2.12-3.59), risperidone (HR 2.70, 95% CI 2.30-3.16), paliperidone (HR 1.84, 95% CI 1.37-2.46), and ziprasidone (HR 1.36, 95% CI 1.06-1.76) were associated with the highest risk of prolactin elevation. In contrast, quetiapine (HR 0.73, 95% CI 0.61-0.87), clozapine (HR 0.59, 95% CI 0.46-0.76), and aripiprazole (HR 0.30, 95% CI 0.23-0.37) were associated with the lowest risk. Amisulpride posed the highest risk among male patients, whereas risperidone posed the highest risk among female patients. Different types of dose-response associations were detected in seven SGAs.

conclusionThis cohort study, conducted in an inpatient setting, identified different risks of prolactin elevation associated with SGAs, along with their dose-response curves. Sex and age must be considered when prolactin elevation is analyzed in patients with schizophrenia who are treated with SGAs.

trial registrationClinicalTrials.gov identifier: NCT04002258.

Indexed as

Antipsychotic AgentsProlactinSchizophreniaAdultChinaCohort StudiesDose-Response Relationship, DrugFemaleHumansMaleMiddle AgedRetrospective StudiesAntipsychotic AgentsProlactin

Identifiers

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.