The Perinatal Synergistic Multi-component Intervention to alLeviate dEpressive Symptoms. A Case Series
Key facts
- Who runs it
- Washington University School of Medicine
- Where
- St Louis, United StatesSee the site
- Trial code
- Status
- Withdrawn
- Phase
- Phase 2/3
- Started
- 15 Oct 2025
- Ended
- 15 Oct 2025
- Type of study
- Interventional
- Treatments tested
- interpersonal psychotherapy (IPT)
- Ketamine
- Record updated
- 29 October 2025
- Why it stopped
- PI is leaving the university
Who can take part
- Sex
- Women only
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
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Who can take part
- 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
Who cannot take part
- 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 in United States
- Barnes-Jewish HospitalSt Louis, United States
About the trial
What the trial wants to find out
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.
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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
The group in the trial
- Intervention Interpersonal psychotherapy plus ketamineTreatment being tested
Five sessions of interpersonal psychotherapy (IPT) and pre-, and post-, ketamine sessions b) Two doses of subcutaneous (SC) ketamine in the first 4 post-cesarean days
Treatment: interpersonal psychotherapy (IPT) and Ketamine
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- The Perinatal SMILES (Synergistic Multi-component Intervention to alLeviate dEpressive Symptoms) Case Series. Combining Ketamine and Interpersonal Psychotherapy to Improve Postpartum Mood
- Record updated
- 29 October 2025