Status:
WITHDRAWN
The Perinatal Synergistic Multi-component Intervention to alLeviate dEpressive Symptoms. A Case Series
Lead Sponsor:
Washington University School of Medicine
Conditions:
Postpartum Depression
Eligibility:
FEMALE
Phase:
PHASE2
PHASE3
Brief Summary
The goal of this open label case series is to learn about the feasibility of conducting a future randomised controlled trial to evaluate how well the Perinatal SMILES intervention works in improving p...
Detailed Description
The investigators will perform an open-label case series to evaluate the feasibility of performing a trial of a novel intervention to reduce postpartum depression symptoms after cesarean delivery. The...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- English-speaking (necessary for IPT under the limitations of the pilot) Socio-economically disadvantaged (i.e., low-income requiring public assistance) Suffering with depressive symptoms (EPDS \> 10) \>18 years of age \> 20 weeks pregnant scheduled for cesarean delivery" or "within 48 hours of an unscheduled (or scheduled) cesarean delivery.
- Exclusion Criteria
- An allergy to ketamine
- Contraindications for TMS including the presence of metallic objects within 30 cm of the TMS coil, intracranial implants (e.g., aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object within or near the head, excluding the mouth, that cannot be safely removed; presence of intracardiac lines, defibrillators or a cardiac pacemaker and unable to assess safety; presence of implanted electronic devices that control physiologic functions and unable to assess safety
- Have a personal history of a primary seizure disorder or a seizure associated with an intracranial lesion
- History of severe head trauma or neurological disorders (e.g., pre-eclampsia) that substantially increase seizure risk, per PI discretion
Exclusion
Key Trial Info
Start Date :
October 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 15 2025
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT06048263
Start Date
October 15 2025
End Date
October 15 2025
Last Update
October 29 2025
Active Locations (1)
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1
Barnes-Jewish Hospital
St Louis, Missouri, United States, 63110