Biomarkers and Pharmacogenomics for Precision Depression Therapy (NCT07738497) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Biomarkers and Pharmacogenomics for Precision Depression Therapy
220 participantsStarted 2026-07-01
Plain-language summary
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.
Who can participate
Age range
14 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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
Exclusion criteria
. History of other psychiatric disorders (e.g., bipolar disorder, schizophrenia)
. Presence of severe physical illnesses or major central nervous system diseases
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial isn't recruiting yet — do you know when it might open, and is there any benefit to me expressing interest now so I'm considered when it does?
2The trial is measuring treatment response using something called the HAMD-17 score over 12 weeks — can you explain what that scale measures and what counts as a meaningful improvement for someone in my situation?
3Since this study involves biomarkers and pharmacogenomics, does that mean they'd be analyzing my genes or biological markers to match me to a depression treatment, and how might that information be used or shared after the study?
4Given that this trial is listed as Phase NA, which I don't fully understand, can you help me figure out how much is already known about the safety and effectiveness of the approach being tested, compared to standard antidepressant treatments I could start now?
5If I were to wait for this trial to open rather than starting a standard treatment right away, what are the realistic risks of delaying care for my depression, and is waiting likely to be worth it?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Title: 12-Week Response Rate Defined by HAMD-17 Score Reduction
Timeframe: From baseline to Week 12.
Trial details
NCT IDNCT07738497
SponsorThe Fourth Affiliated Hospital of Zhejiang University School of Medicine