Pharmacogenomic and Pharmacoepigenomic Studies of Antipsychotic Drugs in First-Episode Schizophrenia

NCT ID: NCT07102069

Last Updated: 2025-08-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 384 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-11-01
• Study Completion Date: 2022-09-14

Brief Summary

This study aims to explore the objective markers concerning schizophrenia risk and functional outcome from multiple dimensions such as multi-omics including genomics, proteomics, metabolomics, electrophysiology, imaging, psychosocial, and cognition. In summary, based on this trial, the significant outcomes may effectively improve the accuracy of early warning and recognition in patients with schizophrenia, and provide clues for the study of new drug targets.

Detailed Description

This trial is a prospective, longitudinal observation clinical trial. In this trial, a total of 300 SZ patients who were never treated with antipsychotic medications or other psychotropics were recruited from out- or in-patients in Tianjin Anding Hospital. Patients received antipsychotic treatment at the discretion of their clinicians. The types of antipsychotics were not restricted. In this longitudinal study, all patients received clinical evaluation scales including the Positive and Negative Syndrome Scale (PANSS), and so on at the main visits (baseline, week8, week12, 1-year, 2-year, 5-year). Importantly, cognitive evaluation using the MATRICS Consensus Cognitive Battery (MCCB) and functional Magnetic Resonance Imaging (fMRI) imaging were collected only at five follow-ups（baseline，week8， 1-year， 2-year， 5-year）. Meanwhile, we also collect related measured factors by collecting a peripheral blood sample and electrophysiological index including Electroencephalogram (EEG) and Functional Near-Infrared Spectroscopy (fNIRS) at multiple time points (baseline, week8, week12, 1-year, 2-year,5-year). 100 healthy subjects were matched to patients in age, gender, race, and education. They completed the same baseline assessment as the patients. what's more, part of the enrolled healthy group will receive an assessment at week8 follow-up.

Conditions

Schizophrenia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

schizophrenic patients

In this trial, a total of 300 schizophrenia patients who were never treated with antipsychotic medications or other psychotropics were recruited from out- or in-patients in Tianjin Anding Hospital. There are no restrictions for the types of antipsychotics. The enrolled patients received assessments at the main visits (baseline, week8, week12,1-year,2-year,5-year).

No interventions assigned to this group

healthy control

100 healthy subjects were matched to patients in age, sex, race, and education. They completed the same baseline assessment as the patients. what's more, part of the enrolled healthy group will receive an assessment at week8 follow-up.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Healthy population matched with gender, age, and educational level of case group;
• Han nationality;
• Sign informed consent.

Exclusion Criteria

• Major physical and brain diseases;
• Any mental disorder in Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV);
• Parents have a family history of mental illness in two lines and three generations;
• Currently taking psychoactive drugs;
• Refuse to participate in this study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Tianjin Anding Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Tianjin Anding Hospital

Tianjin, , China

Countries

China

Other Identifiers

TJAH2017-SCH-LJ

Identifier Type: -

Identifier Source: org_study_id