Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2026-01-03 @ 11:46 PM
Study NCT ID:
NCT06700967
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-11-22
First Post:
2024-10-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluating Pharmacogenomics-Based Pharmacotherapy in Real-World Settings for Schizophrenia
Sponsor:
Shanghai Mental Health Center
Organization:
Study Overview
Official Title:
A Precision Medication Guidance Model for Schizophrenia Based on Pharmacogenomics and Physiologically Based Pharmacokinetics: a Real-World Observational Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
An 8-week, rater-blinded, real-world observational study to investigate the benefits of pharmacogenetics-based pharmacotherapy in patients suffering from schizophrenia.
Detailed Description:
This study, conducted at the Shanghai Mental Health Center, aims to compare changes in treatment efficacy and the frequency and severity of adverse reactions in patients with schizophrenia who have experienced treatment failure, before and after implementing a pharmacogenomics-based precision medication guidance strategy. The research is set in real-world conditions, without a predetermined treatment regimen for participants; instead, medication optimization is guided by pharmacogenomic testing results. Following the receipt of precision medication recommendations for each participant, the study physicians optimize the treatment regimen based on these recommendations and their clinical expertise. Optimization may involve adjusting the dose of current medications (if the existing regimen is largely suitable), switching medications (in cases of inappropriate treatment), or modifying the dose or replacing one of the combined medications (to manage drug-drug interactions). The rationality of the medication regimen will be assessed at the end of weeks 4 and 8, with additional recommendations provided as needed. Treatment effectiveness and safety will be evaluated during follow-up visits at these intervals. A total of 400 patients are planned to be included in the study.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: