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

NCT06048263 · Status: WITHDRAWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL

Last updated 2025-10-29

No results posted yet for this study

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

Conditions

Interventions

BEHAVIORAL

interpersonal psychotherapy (IPT)

The ROSE intervention is a five-session intervention developed to build communication skills, improve social support, and improve stress management. It is easy to learn and does not require a healthcare professional or mental health specialist to deliver. For this study, the investigators plan to deliver to individuals during inpatient visits, in-person appointments or via telemedicine (phone or videoconference), as appropriate or per participant preference. The first four sessions are approximately 60 minutes in length.

DRUG

Ketamine

During the first four post-cesarean days, the investigators will administer subcutaneous ketamine (0.5 mg/kg) and a repeated dose of 0.5 or 0.7 mg/kg \~24 hours later (the second dose will be increased to 0.7 mg/kg if no severe adverse effects are reported after the first dose and the patient is in agreement with the dose escalation).

Sponsors & Collaborators

  • Washington University School of Medicine

    lead OTHER

Principal Investigators

  • David Monks, MBCHB · Washington University School of Medicine

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-15
Primary Completion
2025-10-15
Completion
2025-10-15
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06048263 on ClinicalTrials.gov