SchizophreniaNCT07102069
Pharmacogenomic and Pharmacoepigenomic Studies of Antipsychotic Drugs in First-Episode Schizophrenia
An observational study of Schizophrenia, run by Tianjin Anding Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia
- How many people
- 384 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2017to 14 Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Healthy population matched with gender, age, and educational level of case group;
- Han nationality;
- Sign informed consent.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Keywords
- Schizophrenia, Cohort Study, Cognition, Biomarker
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline, week8, 1year, 2year, 5year
Secondary outcomes (9)
Allelic Frequency of Target Single-Nucleotide Polymorphisms (SNPs)
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.
Measured: Baseline
Gene-Specific DNA Methylation Level
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.
Measured: Baseline
Changes of C-reactive protein (CRP) levels
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.
Measured: Baseline, week8, week12
Changes of interleukin-1β (IL-1β) levels
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.
Measured: Baseline, week8, week12
Changes of interleukin-6 (IL-6) levels
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.
Measured: Baseline, week8, week12
Changes of tumour necrosis factor-α (TNF-α) levels
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.
Measured: Baseline, week8, week12
Resting-State electroencephalography (EEG) Relative Power
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.
Measured: Baseline
Functional near-infrared spectroscopy (fNIRS)
The fNIRS will be used to monitor oxygenated hemoglobin (HbO₂) and deoxygenated hemoglobin (Hb) in the bilateral prefrontal cortex during a working-memory task.
Measured: Baseline
Resting-state functional magnetic resonance imaging (fMRI)
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2025
- Study start1 Nov 2017
- Primary completion14 Jun 2022
- Study completion14 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 384 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tianjin Anding Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07102069
- Sponsor's protocol ID
- TJAH2017-SCH-LJ
- Status last verified
- Jul 2025
- First submitted
- 18 Jul 2025
- Last updated
- 3 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacogenomic and Pharmacoepigenomic Studies of Antipsychotic Drugs in First-Episode Schizophrenia
- ClinicalTrials.gov ID
- NCT07102069
- Acronym / sponsor ID
- TJAH2017-SCH-LJ
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia, Cohort Study, Cognition, Biomarker
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 384 participants (actual)
- Lead sponsor
- Tianjin Anding HospitalUniversity, hospital or other
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 14 Jun 2022 (actual)
- Study completion
- 14 Sep 2022 (actual)
- First posted
- 3 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Healthy population matched with gender, age, and educational level of case group;
- Han nationality;
- Sign informed consent.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
9 secondary outcomes
Allelic Frequency of Target Single-Nucleotide Polymorphisms (SNPs)
Time frame: Baseline
Gene-Specific DNA Methylation Level
Time frame: Baseline
Changes of C-reactive protein (CRP) levels
Time frame: Baseline, week8, week12
Changes of interleukin-1β (IL-1β) levels
Time frame: Baseline, week8, week12
Changes of interleukin-6 (IL-6) levels
Time frame: Baseline, week8, week12
Changes of tumour necrosis factor-α (TNF-α) levels
Time frame: Baseline, week8, week12
Resting-State electroencephalography (EEG) Relative Power
Time frame: Baseline
Functional near-infrared spectroscopy (fNIRS)
Time frame: Baseline
Resting-state functional magnetic resonance imaging (fMRI)
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Schizophrenia, run by Tianjin Anding Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of psychiatric symptoms (time frame: Baseline, week8, week12, 1year, 2year, 5year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2025.