An 8-week, rater-blinded, real-world observational study to investigate the benefits of pharmacogenetics-based pharmacotherapy in patients suffering from schizophrenia.
Eligibility
Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria:
1. Suffer from schizophrenia (as assessed in agreement with ICD-11 criteria).
2. Age between ≥18 and \<65 years.
3. Currently receiving inpatient or outpatient psychiatric treatment.
4. Experienced any of the following suboptimal treatment conditions while receiving antipsychotic medication within the therapeutic dosage range:
1. Standard antipsychotic treatment for more than 2 weeks with the occurrence of drug-induced adverse effects requiring dose adjustment or a switch of medication.
2. Antipsychotic treatment within the therapeutic dosage range for more than 4 weeks, with the presence of at least two items of the Positive and Negative Syndrome Scale (PANSS) (P1, P2, P3, N1, N4, N6, G5, and G9) score ≥4, or a total PANSS score \>70, or a CGI-S score ≥4.
3. Other situations where a change in medication is deemed necessary, as assessed by senior clinical physicians.
5. Understand the study requirements and provide written informed consent to participate; a signed and dated informed consent form (ICF) will be obtained from each patient before participation in the study.
Exclusion Criteria:
1. Presence of organic brain disease or a severe and/or unstable physical condition.
2. Substance abuse or dependence within the past 6 months or currently.
3. Presence of elevated levels of agitation, impulsivity, or risk of self-injury or suicide.
4. Pregnant or breastfeeding women.
5. The presence of any other conditions that may render the individual ineligible for participation in this clinical trial.
Primary outcome measure(s)
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Total Score at Week 4 and Week 8 — 4 weeks and 8 weeks The Positive and Negative Syndrome Scale (PANSS) provides a total score (sum of the scores of all 30 items) and scores for 3 subscales, the positive subscale (7 items), the negative subscale (7 items), and the general psychopathology subscale (16 items), each rated on a scale of 1 (absent) to 7 (extreme). It's designed to capture symptoms of schizophrenia. Score range 30-210. A higher score means a worse outcome.
Trial sites (1)
Facility
City
Region
Status
Shanghai Mental Health Center
Shanghai
China
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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