drugset / Trial / NCT06048263

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

NCT06048263

NaSingle-groupOpen-labelPrevention

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

Timeline

Start
2025-10-15
Primary completion
2025-10-15
Completion
2025-10-15

Drugs

EvaluationDrugModalityDoseRoute
Subject Ketamine Small molecule 0.5 mg/kg Subcutaneous
Subject Ketamine Small molecule 0.7 mg/kg Subcutaneous

Indications