Multimodal Biomarkers and Precision TMS for Postpartum Depression

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorUniversity of Macau

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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).

Trial design

Treatments tested in this trial

  • Repetitive Transcranial Magnetic Stimulation (rTMS)

Treatment groups

290 Participants
are divided into 3 treatment groups

Sponsors and collaborators

University of Macau

Lead sponsor

Kiang Wu Hospital

Collaborator