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:
Participant gender:
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