Not Yet RecruitingNot Applicable

Multimodal Biomarkers and Precision TMS for Postpartum Depression

Macau290 participantsStarted 2026-09-01

Plain-language summary

The purpose of this study is to identify multimodal biological markers associated with postpartum depression (PPD) and to evaluate the effectiveness of precision brain stimulation treatment. PPD is a common mental health condition after childbirth that can affect maternal well-being and early child development. Current identification of PPD relies largely on clinical assessments and screening questionnaires, which may not fully capture underlying biological changes. This study uses brain activity, cardiac signals, blood-based biomarkers, interoceptive assessments, and clinical measures to characterize multimodal biological profiles associated with PPD and treatment response. The main questions it aims to answer are: * What multimodal biological differences exist between women with diagnosed PPD and healthy comparison groups, including postpartum and non-postpartum controls? * Which biological or psychological markers can predict whether a patient will respond well to repetitive transcranial magnetic stimulation (rTMS) treatment? * Can a clinical model be created to help doctors choose the best treatment based on these markers? The study focuses on characterizing multimodal biological differences in women with diagnosed PPD and examining clinical response profiles following rTMS treatment, rather than predicting the onset of PPD in the general population. Participants will: * Undergo electroencephalography (EEG) using a 128-channel cap to measure neural activity. * Have electrocardiography (ECG) recorded to analyze heart rate variability and autonomic function. * Provide blood samples to measure inflammatory cytokines, endocrine levels, and metabolic markers. * Complete Interoceptive Assessments (tasks to measure awareness of internal body signals) and clinical psychological surveys. * Complete follow-up assessments via online surveys and scheduled visits at 2 weeks, 1 month, and 3 months postpartum. Participants in the PPD group will: * Receive 4 weeks of high-precision, robot-guided rTMS treatment (20 sessions total). * Undergo pre-intervention multimodal assessments, including EEG, ECG, blood biomarkers, and interoceptive tasks, to identify potential predictors of clinical response to rTMS treatment.

Who can participate

Age range

18 Years – 45 Years

Sex

FEMALE

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: * Biological female, aged 18-45 years. * For HR-PPD and LR-PPD groups: Pregnant women in the third trimester (≥ 32 weeks gestation) with a singleton pregnancy. * For HR-PPD group: Beck Depression Inventory (BDI) score ≥ 14 during the third trimester. * For LR-PPD group: BDI score \< 14 during the third trimester, with no history of depression. * For HC group: Healthy women with no pregnancy in the past 12 months. * No history of central nervous system diseases or major medical/surgical conditions. * No history of medication use that may interfere with EEG or ECG measurements. * Willing and able to complete baseline and follow-up assessments and provide written informed consent. Exclusion Criteria: * Multiple pregnancies, preterm labor, or severe pregnancy complications (e.g., pre-eclampsia, gestational diabetes with complications). * Life-threatening emergencies during delivery (e.g., amniotic fluid embolism, major hemorrhage). * Cognitive impairment or language barriers that hinder cooperation with assessments. * History of major psychiatric disorders (e.g., schizophrenia, bipolar disorder). * Other conditions that, in the opinion of the investigator, make the participant unsuitable for the study.

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.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

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

Postpartum depressive symptom severity measured by the Edinburgh Postnatal Depression Scale (EPDS)

Timeframe: T0 (Baseline, third trimester of pregnancy); T1 (2 weeks postpartum remote follow-up); T2 (1 month postpartum remote follow-up); T3 (3 months postpartum remote follow-up); Pre-rTMS treatment

Self-reported depressive symptom severity measured by the Beck Depression Inventory-II (BDI-II)

Depression severity measured by the 17-item Hamilton Depression Rating Scale (HAMD-17)

Quality of life measured by the WHO Quality of Life Instrument-Short Form (WHOQOL-BREF)

Body perception and autonomic awareness measured by the Body Perception Questionnaire-Short Form (BPQ-SF)

Trial details

NCT IDNCT07757815

SponsorUniversity of Macau

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2030-09-01

Contact for this trial

Cheng Teng Ip, PhD

(853) 8822-9378 chengtengip@um.edu.mo

View on ClinicalTrials.gov More Depression, Postpartum trials