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Behavioral Intervention

IPT + Ketamine for Postpartum Depression (SMILES Trial)

Phase 2 & 3

Waitlist Available

Led By David Monks, MBCHB

Research Sponsored by Washington University School of Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

English-speaking (necessary for IPT under the limitations of the pilot)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through postoperative day 84

Awards & highlights

SMILES Trial Summary

This trial aims to find out if it's feasible to conduct a study to see if a therapy and ketamine injections can help low-income women improve post-cesarean mood.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Potential side effects from ketamine may include disorientation, dizziness, nausea, increased blood pressure and heart rate. Interpersonal therapy does not have physical side effects but can sometimes bring up emotional discomfort.

SMILES Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I speak English.

SMILES Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through postoperative day 84

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through postoperative day 84

This trial's timeline: 3 weeks for screening, Varies for treatment, and through postoperative day 84 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Adverse effects - Blurred vision

Adverse effects - amnesia

Adverse effects - diplopia

+17 more

SMILES Trial Design

1Treatment groups

Experimental Treatment

Group I: Intervention Interpersonal psychotherapy plus ketamineExperimental Treatment2 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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ketamine

2011

Completed Phase 4

~1090

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor

1,935 Previous Clinical Trials

2,299,782 Total Patients Enrolled

5 Trials studying Postpartum Depression

2,446 Patients Enrolled for Postpartum Depression

David Monks, MBCHBPrincipal InvestigatorWashington University School of Medicine

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any vacancies remaining for participants in this research?

"Unfortunately, this investigation is no longer recruiting according to the information on clinicaltrials.gov; it was first posted in September of 2023 and last updated two weeks later. However, there are currently 1234 other trials actively looking for participants at present."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

David Monks 2024. "The Perinatal Synergistic Multi-component Intervention to alLeviate dEpressive Symptoms. A Case Series". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06048263.