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

NCT07102069 | Completed DMC

• 1 other identifier: TJAH2017-SCH-LJ
• Study Type: observational
• Target: 384
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia

Keywords

Schizophrenia; Cohort Study; Cognition; Biomarker

Outcome Measures

Primary Outcomes (2)

• Changes of psychiatric symptoms

  The psychiatric symptoms of schizophrenia were assessed in all enrolled patients using the Positive and Negative Syndrome Scale (PANSS). The PANSS is a 30-item clinician-rated scale yielding a total score ranging from 30 (least symptomatic) to 210 (symptomatic), where higher scores indicate more severe psychopathology. Trained raters administered the PANSS at multiple follow-up visits: baseline, Week 8, Week 12, 1 year, 2 years, and 5 years.

  Baseline, week8, week12, 1year, 2year, 5year

• Changes of cognitive function

  All subjects received baseline cognitive evaluation using the MATRICS Consensus Cognitive Battery (MCCB). It involves seven cognitive areas: (1) Speed of Processing Information; (2) Attention and Vigilance Awareness; (3) Working Memory; (4): Verbal Learning; (5) Visual Learning; (6) Reasoning and Problem-Solving; (7) Social Cognition. The MCCB scoring program generates T-scores that are standardized and corrected for age and sex. A higher T score indicates better cognitive function. The cognitive composite is the standardized sum of the seven domains.

  Baseline, week8, 1year, 2year, 5year

Secondary Outcomes (9)

• Allelic Frequency of Target Single-Nucleotide Polymorphisms (SNPs)

  Baseline

• Gene-Specific DNA Methylation Level

  Baseline

• Changes of C-reactive protein (CRP) levels

  Baseline, week8, week12

• Changes of interleukin-1β (IL-1β) levels

  Baseline, week8, week12

• Changes of interleukin-6 (IL-6) levels

  Baseline, week8, week12

Study Arms (2)

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).

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.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

In this trial, a total of 300 schizophrenia patients who were never treated with antipsychotic medications or other psychotropics were recruited. And the case group received assessments including clinical evaluation scales, collecting peripheral blood samples, and so on at the main visits (baseline, week8, week12,1-year,2-year,5-year). Importantly there are no restrictions on the types of antipsychotics. 100 healthy subjects considering age, gender, race, and years of education controls completed the same baseline assessment as the patients at baseline. what's more, part of the enrolled healthy group will receive an assessment at week8 follow-up.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tianjin Anding Hospital: lead

Study Sites (1)

Tianjin Anding Hospital

Tianjin, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

We will retain peripheral blood samples collected at baseline and follow-up visits. These samples will be stored at -80 °C for future DNA extraction, genotyping, and methylation analyses.

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2025
• First Posted: August 3, 2025
• Study Start: November 1, 2017
• Primary Completion: June 14, 2022
• Study Completion: September 14, 2022
• Last Updated: August 3, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)