Skip to content

The association study of candidate gene polymorphisms with the therapeutic efficacy and safety of oral paliperidone in Chinese Han population

The association study of candidate gene polymorphisms with the therapeutic efficacy and safety of oral paliperidone in Chinese Han population

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100048320
Enrollment
Unknown
Registered
2021-07-05
Start date
2021-09-01
Completion date
Unknown
Last updated
2023-03-20

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

Conditions

Schizophrenia

Interventions

Schizophrenia group:Parliperidone

Sponsors

Institute of Mental Health, the Sixth Hospital of Peking University
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 are in the acute stage of the first episode without medication or chronic course of disease; 5.The total score of the Positive and Negative Symptom Scale (PANSS) >=60 points (1-7 scale), among the 7 positive symptom items, the score >=4 must be >=3; 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.Pregnant or breast-feeding women or those planning to become pregnant; 2.Patients with contraindications to paliperidone; 3.Patients with severe or unstable physical diseases; 4. Having the following cardiac conditions: prolonged QTc interval (QTc>=450 ms in men or 470 ms in women); Decompensated congestive heart failure; Complete left bundle branch block.

Design outcomes

Primary

MeasureTime frame
Positive And Negative Syndrome Scale, PANSS;Gene data;

Secondary

MeasureTime frame
Clinical global impression, CGI;

Countries

China

Contacts

Public ContactYue Weihua

Institute of Mental Health, the Sixth Hospital of Peking University

dryue@bjmu.edu.cn+86 18810898027

Outcome results

None listed

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