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Association between ITIH2 gene polymorphism and aripiprazole in improving hyperprolactinemia induced by antipsychotics

Genetic susceptibility of schizophrenia: Association between ITIH2 gene polymorphism and aripiprazole in improving hyperprolactinemia induced by antipsychotics

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300079155
Enrollment
Unknown
Registered
2023-12-26
Start date
2024-01-01
Completion date
Unknown
Last updated
2024-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia

Interventions

Patients with hyperprolactinemia:NA

Sponsors

Peking University Sixth Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: 1) Each patient should be diagnosed as schizophrenia according to the DSM-IV-TR criteria; 2) Aged 18 to 45 years, han nationality, no gender limitation; 3) Biological parents are Chinese Han descents; 4) Patients with schizophrenia who received risperidone or paliperidone; 5) PRL > 50ng/ml; 6) Obtain the written informed consent of the patient, or the written informed consent of the legal guardian if the patient is incapacitated during the onset.

Exclusion criteria

Exclusion criteria: 1) Patients with the following DSM-5 diagnoses: organic mental disorders, depressive disorders, schizoaffective disorders, bipolar disorders, mental retardation, dementia, other cognitive disorders, alcohol and drug dependence, and Axis II disorders including personality disorders; 2) Those who are seriously suicidal or at risk of injuring others; 3) suffering from a serious or unstable physical disease; 4) Have a history of seizures; 5) Known pregnancy and/or breastfeeding, or planning pregnancy; 6) Participate in another clinical trial at the same time, unwilling or unable to complete the full course of the trial; 7) Patients with contraindications to risperidone, paliperidone and aripiprazole; 8) Diagnosis of pituitary tumor, hypothalamic disease, thyroid disease, primary or secondary amenorrhea.

Design outcomes

Primary

MeasureTime frame
prolactin;

Secondary

MeasureTime frame
Positive And Negative Syndrome Scale, PANSS;Clinical global impression, CGI;

Countries

China

Contacts

Public ContactWeihua Yue

Peking University Sixth Hospital

dryue@bjmu.edu.cn+86 188 1089 8027

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026