Pharmacogenomic and Pharmacoepigenomic Studies of Antipsychotic Drugs in First-Episode Schizophrenia
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Tianjin Anding Hospital
- Enrollment
- 384
- Locations
- 1
- Primary Endpoint
- Changes of psychiatric symptoms
Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Outcomes
Primary Outcomes
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.
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
- 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)
- Changes of tumour necrosis factor-α (TNF-α) levels(Baseline, week8, week12)
- Resting-State electroencephalography (EEG) Relative Power(Baseline)
- Functional near-infrared spectroscopy (fNIRS)(Baseline)
- Resting-state functional magnetic resonance imaging (fMRI)(Baseline)