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出境医 / 临床实验 / Prolactin Change in Chinese Patients With Schizophrenia After Antipsychotics Treatment
Prolactin Change in Chinese Patients With Schizophrenia After Antipsychotics Treatment
Study Description
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:
- Review of electronic medical records of schizophrenia patients who were brought to Shanghai Mental Health Center since January 1, 2007.
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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.
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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.
| Condition or disease | Intervention/treatment |
|---|---|
| Schizophrenia Antipyretics Toxicity Prolactin Excess | Drug: Antipsychotic |
Study Design
| Study Type : | Observational |
| Estimated Enrollment : | 10000 participants |
| Observational Model: | Cohort |
| Time Perspective: | Retrospective |
| Official Title: | Prolactin Change and Its Effectors in Chinese Patients With Schizophrenia After Antipsychotics Treatment |
| Actual Study Start Date : | June 6, 2019 |
| Estimated Primary Completion Date : | November 2020 |
| Estimated Study Completion Date : | December 2020 |
Arms and Interventions
Outcome Measures
Primary Outcome Measures :
- 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.
Secondary Outcome Measures :
- prolactin level at other time points [ Time Frame: after 2-month, 3-month and half a year treatment with antipsychotics ]Different patients have different tendencies of prolactin, so collecting prolactin level at different time after exposed to antipsychotics is necessary.
Eligibility Criteria
Contacts and Locations
| Tracking Information | ||||
|---|---|---|---|---|
| First Submitted Date | March 26, 2019 | |||
| First Posted Date | June 28, 2019 | |||
| Last Update Posted Date | January 2, 2020 | |||
| Actual Study Start Date | June 6, 2019 | |||
| Estimated Primary Completion Date | November 2020 (Final data collection date for primary outcome measure) | |||
| Current Primary Outcome Measures |
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.
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| Original Primary Outcome Measures | Same as current | |||
| Change History | ||||
| Current Secondary Outcome Measures |
prolactin level at other time points [ Time Frame: after 2-month, 3-month and half a year treatment with antipsychotics ] Different patients have different tendencies of prolactin, so collecting prolactin level at different time after exposed to antipsychotics is necessary.
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| Original Secondary Outcome Measures | Same as current | |||
| Current Other Pre-specified Outcome Measures | Not Provided | |||
| Original Other Pre-specified Outcome Measures | Not Provided | |||
| Descriptive Information | ||||
| Brief Title | 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 | |||
| 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:
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| Detailed Description | Not Provided | |||
| Study Type | Observational | |||
| Study Design | Observational Model: Cohort Time Perspective: Retrospective |
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| Target Follow-Up Duration | Not Provided | |||
| Biospecimen | Not Provided | |||
| Sampling Method | Non-Probability Sample | |||
| Study Population | patients with schizophrenia who were taking or going to take antipsychotic medicine. | |||
| Condition |
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| Intervention | Drug: Antipsychotic
any antipsychotic medicine that would have the effect on prolactin level, such as amisulpride, risperidone, olanzapine and so on.
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| Study Groups/Cohorts | Not Provided | |||
| Publications * | Not Provided | |||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | ||||
| Recruitment Status | Active, not recruiting | |||
| Estimated Enrollment |
10000 | |||
| Original Estimated Enrollment | Same as current | |||
| Estimated Study Completion Date | December 2020 | |||
| Estimated Primary Completion Date | November 2020 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 14 Years and older (Child, Adult, Older Adult) | |||
| Accepts Healthy Volunteers | No | |||
| Contacts | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries | China | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number | NCT04002258 | |||
| Other Study ID Numbers | CRC2018DSJ01-2 | |||
| Has Data Monitoring Committee | Not Provided | |||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | LI, Huafang, Shanghai Mental Health Center | |||
| Study Sponsor | Shanghai Mental Health Center | |||
| Collaborators | Not Provided | |||
| Investigators |
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| PRS Account | Shanghai Mental Health Center | |||
| Verification Date | December 2019 | |||
