IPT + Ketamine for Postpartum Depression

(SMILES Trial)

Overseen By Haley Bernstein

Age: Any Age

Sex: Female

Trial Phase: Phase 2 & 3

Sponsor: Washington University School of Medicine

Disqualifiers: Seizure disorder, Severe head trauma, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 4 days

25 Participants Needed

Trial Summary

What is the purpose of this trial?

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

Research Team

David Monks, MBCHB

Principal Investigator

Washington University School of Medicine

Eligibility Criteria

This trial is for English-speaking, low-income women who are 20-32 weeks pregnant and scheduled for a cesarean delivery or within 48 hours post-cesarean. They must be experiencing depressive symptoms (EPDS > 10). It's not open to those with ketamine allergies, seizure disorders, metal implants near the brain, cardiac devices, or severe head trauma.

Inclusion Criteria

You are from a socio-economically disadvantaged background, requiring public assistance.

You are 20 - 32 weeks pregnant, have a score of 10 or higher on the EPDS test for depressive symptoms, and are either scheduled to undergo a cesarean delivery within 48 hours or have recently had an unscheduled (or scheduled) cesarean delivery.

Exclusion Criteria

You have had a serious head injury or a neurological disorder that greatly increases your risk of having seizures, as determined by the study doctor.

I have a history of seizures due to a brain disorder or lesion.

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 day

Treatment

Participants receive two subcutaneous ketamine injections approximately 24 hours apart, and complete five sessions of interpersonal therapy

4 days

Multiple visits for ketamine injections and therapy sessions

Follow-up

Participants are monitored for mood and brain activity assessments over the first 12 postpartum weeks

12 weeks

Treatment Details

Interventions

• Interpersonal Psychotherapy (IPT)
• Ketamine

Trial Overview The Perinatal SMILES intervention combines interpersonal therapy with two doses of subcutaneous ketamine after cesarean birth. The study will assess its feasibility and effects on mood through EEGs before/after treatment and mood assessments over the first three months postpartum.

Participant Groups

Group I: Intervention Interpersonal psychotherapy plus ketamine Experimental Treatment 2 Interventions

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

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+