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Completed

NCT Number: NCT07102069

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

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.

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Tianjin Anding Hospital

Tianjin, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Changes of psychiatric symptoms

    Time frame: Baseline, week8, week12, 1year, 2year, 5year

    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.

  2. Changes of cognitive function

    Time frame: Baseline, week8, 1year, 2year, 5year

    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.

Secondary outcomes

  1. Allelic Frequency of Target Single-Nucleotide Polymorphisms (SNPs)

    Time frame: Baseline

    We will quantify the allelic frequency of pre-specified SNPs using DNA extracted from peripheral blood. Results are reported as the percentage of each allele (%) at each locus.

  2. Gene-Specific DNA Methylation Level

    Time frame: Baseline

    We will measure DNA methylation at CpG sites within candidate genes using bisulfite pyrosequencing. Results are reported as the percentage (%) of methylated cytosines at each interrogated site.

  3. Changes of C-reactive protein (CRP) levels

    Time frame: Baseline, week8, week12

    Serum CRP will be quantitatively measured using an enzyme-linked immunosorbent assay. The results will be expressed as the absolute change in CRP concentration (mg/L) between the baseline value and the measured value, with higher values indicating more severe systemic inflammation.

  4. Changes of interleukin-1β (IL-1β) levels

    Time frame: Baseline, week8, week12

    Serum IL-1β will be quantitatively measured using an enzyme-linked immunosorbent assay. The results will be expressed as the absolute change in CRP concentration (pg/mL) between the baseline value and the measured value, with higher values indicating more severe systemic inflammation.

  5. Changes of interleukin-6 (IL-6) levels

    Time frame: Baseline, week8, week12

    Serum IL-6 will be quantitatively measured using an enzyme-linked immunosorbent assay. The results will be expressed as the absolute change in CRP concentration (pg/mL) between the baseline value and the measured value, with higher values indicating more severe systemic inflammation.

  6. Changes of tumour necrosis factor-α (TNF-α) levels

    Time frame: Baseline, week8, week12

    Serum TNF-α will be quantitatively measured using an enzyme-linked immunosorbent assay. The results will be expressed as the absolute change in CRP concentration (μg/L) between the baseline value and the measured value, with higher values indicating more severe systemic inflammation.

  7. Resting-State electroencephalography (EEG) Relative Power

    Time frame: Baseline

    Resting-state EEG will be recorded with 32-channel active electrodes at 1 kHz sampling. Relative power in the theta (4-8 Hz) and alpha (8-13 Hz) bands will be calculated using fast Fourier transform.

  8. Functional near-infrared spectroscopy (fNIRS)

    Time frame: Baseline

    The fNIRS will be used to monitor oxygenated hemoglobin (HbO₂) and deoxygenated hemoglobin (Hb) in the bilateral prefrontal cortex during a working-memory task.

  9. Resting-state functional magnetic resonance imaging (fMRI)

    Time frame: Baseline

    A single resting-state BOLD-fMRI scan will be acquired at baseline using a 3 T scanner (TR=2000 ms, TE=30 ms, voxel size=3 mm isotropic). Functional connectivity between the dorsolateral prefrontal cortex (seed) and the whole brain will be computed as Fisher-z transformed correlation coefficients. The outcome is the baseline connectivity strength expressed as z-score; higher positive z-scores indicate stronger connectivity.

Sponsors and collaborators

Lead sponsor

Tianjin Anding Hospital

Other

Registry information

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Aug 3, 2025
Registry last updated
Aug 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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