WithdrawnPhase 2 / Phase 3

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

NCT06048263 · SMILES · Washington University School of Medicine

Closed to entry

Status

Not accepting participants

Phase 2 / Phase 3

Phase

—

Target enrolment

Study sites

1 US states

What it is testing

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

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

Depressive symptoms
Measured over through postoperative day 84
P30 (TMS-evoked potential)
Measured over 4 days
N45 (TMS-evoked potential)
Measured over 4 days
P60 (TMS-evoked potential)
Measured over 4 days
N100 (TMS-evoked potential)
Measured over 4 days
Cortical evoked activity (CEA)
Measured over 4 days
Anxiety
Measured over through postoperative day 84
Psychosocial stress
Measured over at enrollment 1 day
Post-Traumatic Stress Disorder (PTSD)
Measured over through postoperative day 84
Obstetric Quality of Recovery
Measured over through postoperative day 84
Number of participants who successfully breastfeed their newborn baby
Measured over 4 days
Adverse effects - sedation
Measured over 4 days
Adverse effects - Blurred vision
Measured over 4 days
Adverse effects - diplopia
Measured over 4 days
Adverse effects - dizziness
Measured over 4 days
Adverse effects - euphoria
Measured over 4 days
Adverse effects - amnesia
Measured over 4 days
Adverse effects - hallucinations
Measured over 4 days
Adverse effects - nystamus
Measured over 4 days
Antidepressant treatment
Measured over through postoperative day 84

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

Not stated

Ages

FEMALE

Sex

Not accepted

Healthy volunteers

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

Where

1 study site

Facility	City	Region	Country
Barnes-Jewish Hospital	St Louis	Missouri	United States

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

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NCT06048263 on ClinicalTrials.gov →

Last updated in the registry 2025-10-29. Registry records change; this page reflects the data build of 2026-08-25.

Where this trial sits

Substance

Ketamine

Indication

Postpartum Depression16

Recruiting in

Missouri22

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