NCT07738497Not yet recruiting
Biomarkers and Pharmacogenomics for Precision Depression Therapy
Study on Multidimensional Biomarkers of Depression and Individualized Therapy Based on Pharmacogenomic Technology
Source: ClinicalTrials.gov · Last updated 31 Jul 2026
Brief summary (registry, in English)
Background: The clinical management of major depressive disorder (MDD) is hampered by the lack of objective biomarkers and high inter-individual variability in drug response, with conventional antidepressants achieving only a 50% response rate. Objective and Design: This prospective, randomized, parallel-controlled trial aims to enroll 220 MDD patients, who will be allocated 1:1 to either a pharmacogenomics (PGx)-guided therapy group (treatment selection based on genetic testing) or a conventional treatment group (treatment as usual per guidelines), with a 12-week follow-up. Additionally, a matched healthy control cohort will be included for cross-sectional biomarker comparisons. Intervention and Outcomes: Patients in the PGx group undergo buccal swab testing for key genetic polymorphisms (e.g., CYP2D6, CYP2C19) to inform antidepressant type and dosage. The primary outcome is the 12-week response rate (≥50% reduction in HAMD-17 score from baseline). Secondary outcomes include remission rate, incidence of adverse drug reactions, and medication adjustment frequency. Exploratory Aims: Multidimensional baseline data-including resting-state fMRI (VMHC), peripheral blood biomarkers (inflammatory cytokines, thyroid function, BDNF), urinary metabolites, and gut microbiome-will be integrated to construct a predictive model for treatment efficacy and to identify novel MDD biomarkers. Scientific Significance: This study seeks to validate the clinical utility of PGx-guided prescribing and to advance the shift from symptom-based diagnosis towards a biological-characteristic-based precision medicine framework for depression.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 220 (estimated)
- First submitted
- 28 Jun 2026
- Start date
- 1 Jul 2026
- Primary completion date
- 19 Jan 2029
- Lead sponsor
- The Fourth Affiliated Hospital of Zhejiang University School of Medicine
- Diseases
- Depression
- NCT number
- NCT07738497
What you commit to
- Study type: Interventional
- Planned participants: 220
- From 1 Jul 2026 to the primary completion date, 19 Jan 2029
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- History of other psychiatric disorders (e.g., bipolar disorder, schizophrenia)
- Presence of severe physical illnesses or major central nervous system diseases
- History of sedative-hypnotic, alcohol, or substance abuse
Lab values
- Significant abnormalities in ECG, complete blood count, or liver/kidney/thyroid function tests
Other
- Pregnancy, lactation, or planning to become pregnant during the study
Who the study is looking for
- Clinical diagnosis of Major Depressive Disorder (MDD) according to DSM-5 criteria
- Age between 18 and 60 years
- Baseline HAMD-17 total score ≥ 17
- Ability to provide written informed consent
Age in the registry: 14 years to 60 years · Sex: All · Accepts healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.