The Perinatal Synergistic Multi-component Intervention to alLeviate dEpressive Symptoms. A Case Series

• Status: Not yet recruiting
• Trial end date: 2025-04-01
• Target enrollment: 0
• Participant gender: Female

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 post-cesarean mood in low-income women.

The main questions it aims to answer are:

1. Is it feasible to recruit a sufficient number of participants?

2. Is it feasible to administer Perinatal SMILES and

3. Is it feasible to collect participant outcomes?

To profile EEG in participants at rest and in response to TMS, before and after subcutaneous ketamine

Participants will:

1. Complete five sessions of interpersonal therapy

2. Receive two skin injections of ketamine, approximately 24 hours apart, in the first four postpartum day

3. Receive additional therapy sessions before (to prepare for ketamine) and after (interpersonal therapy) each ketamine injection

4. Undergo assessments of brain electrical activity (at rest and evoked by trans-cranial magnetic stimulation) before and at three timepoints in the 10 hours after each ketamine injection

5. Complete mood assessments over the first 12 postpartum weeks

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Washington University School of Medicine
• Treatments: Ketamine

Criteria

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