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

This open-label case series trial (n=25) will assess the feasibility of conducting a future randomised controlled trial to evaluate the effectiveness of the Perinatal SMILES intervention in improving post-cesarean mood (postpartum depression; PPD) in low-income women.

The intervention combines interpersonal therapy with subcutaneous ketamine therapy. Participants will undergo five sessions of interpersonal therapy and receive two skin injections of ketamine, approximately 24 hours apart, in the first four postpartum days. Brain electrical activity will be assessed before and after the ketamine injections, and mood will be evaluated over the first 12 postpartum weeks.

The primary goal is to determine the feasibility of recruiting participants, administering the intervention, and collecting outcome data. This study is led by the Washington University School of Medicine and is scheduled to start in May 2024, with an estimated completion date of April 2025.

Status Not yet recruiting
Results Published No
Start date 01 May 2024
End date 01 April 2025
Phase Phase II Phase III
Design Open
Type Interventional
Generation First
Participants 25
Sex Female
Therapy Yes

Trial Details

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

Trial Number NCT06048263

Sponsors & Collaborators

Washington University School of Medicine
Located in St. Louis Missouri, researchers at the Washington University School of Medicine have conducted a number of studies with psychedelics inlcuding ketamine, psilocybin and nitrous oxide.

Data attribution

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