Biomarkers and Pharmacogenomics for Precision Depression Therapy

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Conditions studied: Depression / Major Depressive Disorder

In brief

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.

Key facts

Study ID

NCT07738497

Run by

The Fourth Affiliated Hospital of Zhejiang University School of Medicine

People needed

220

Starts

2026-07-01

Expected to finish

2029-01-19

Last updated by the study team

2026-07-31

Who can join

Age: 14 and older, up to 60. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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
• Pregnancy, lactation, or planning to become pregnant during the study
• Significant abnormalities in ECG, complete blood count, or liver/kidney/thyroid function tests

Full record on ClinicalTrials.gov

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