Not Yet RecruitingNot Applicable

Evaluating Pharmacogenomics-Based Pharmacotherapy in Real-World Settings for Schizophrenia

China400 participantsStarted 2024-12-01

Plain-language summary

An 8-week, rater-blinded, real-world observational study to investigate the benefits of pharmacogenetics-based pharmacotherapy in patients suffering from schizophrenia.

Who can participate

Age range18 Years – 65 Years

SexALL

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Inclusion criteria

✓. Suffer from schizophrenia (as assessed in agreement with ICD-11 criteria).
✓. Age between ≥18 and \<65 years.
✓. Currently receiving inpatient or outpatient psychiatric treatment.
✓. Experienced any of the following suboptimal treatment conditions while receiving antipsychotic medication within the therapeutic dosage range:
✓. Standard antipsychotic treatment for more than 2 weeks with the occurrence of drug-induced adverse effects requiring dose adjustment or a switch of medication.
✓. 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.
✓. Other situations where a change in medication is deemed necessary, as assessed by senior clinical physicians.
✓. 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

✕. Presence of organic brain disease or a severe and/or unstable physical condition.
✕. Substance abuse or dependence within the past 6 months or currently.
✕. Presence of elevated levels of agitation, impulsivity, or risk of self-injury or suicide.
✕. Pregnant or breastfeeding women.
✕. The presence of any other conditions that may render the individual ineligible for participation in this clinical trial.

What they're measuring

Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Total Score at Week 4 and Week 8

Timeframe: 4 weeks and 8 weeks

Trial details

NCT IDNCT06700967

SponsorShanghai Mental Health Center

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-12-31

Contact for this trial

YU, Prof.

+86 021-3477-3299 yushunying@smhc.org.cn

View on ClinicalTrials.gov More Schizophenia Disorder trials