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

Primary Purpose

Postpartum Depression

Status
Not yet recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
interpersonal psychotherapy (IPT)
Ketamine
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postpartum Depression focused on measuring Pregnancy, Socio-economically disadvantaged, Cesarean, Postpartum depression

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept 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) -> 20 - 32 weeks pregnant and 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

Sites / Locations

  • Barnes-Jewish Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention Interpersonal psychotherapy plus ketamine

Arm Description

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

Outcomes

Primary Outcome Measures

Depressive symptoms
These will be assessed using the Edinburgh Postpartum Depression Scale (EDPS) questionnaire.30 The EPDS is a set of ten questions about the subject's mood in the previous seven days. Each symptom is scored on a numeric rating scale of none (0) to severe (3). Commonly employed thresholds for psychiatric referral are 10-13 out of a possible 30 points.
P30 (TMS-evoked potential)
This will be assessed using TMS-EEG. The amplitude of each of component positive (P) and negative (N) deflections in the evoked EEG signal will be recorded before and at 3 timepoints in the 2-10 hours after ketamine. The component deflections are named according to polarity of the deflection (N = negative, P = Positive) and the approximate time in milliseconds after the TMS input. For example N45 is the negative deflection observed approximately 45 ms after the TMS input.
N45 (TMS-evoked potential)
This will be assessed using TMS-EEG. The amplitude of each of component positive (P) and negative (N) deflections in the evoked EEG signal will be recorded before and at 3 timepoints in the 2-10 hours after ketamine. The component deflections are named according to polarity of the deflection (N = negative, P = Positive) and the approximate time in milliseconds after the TMS input. For example N45 is the negative deflection observed approximately 45 ms after the TMS input.
P60 (TMS-evoked potential)
This will be assessed using TMS-EEG. The amplitude of each of component positive (P) and negative (N) deflections in the evoked EEG signal will be recorded before and at 3 timepoints in the 2-10 hours after ketamine. The component deflections are named according to polarity of the deflection (N = negative, P = Positive) and the approximate time in milliseconds after the TMS input. For example N45 is the negative deflection observed approximately 45 ms after the TMS input.
N100 (TMS-evoked potential)
This will be assessed using TMS-EEG. The amplitude of each of component positive (P) and negative (N) deflections in the evoked EEG signal will be recorded before and at 3 timepoints in the 2-10 hours after ketamine. The component deflections are named according to polarity of the deflection (N = negative, P = Positive) and the approximate time in milliseconds after the TMS input. For example N45 is the negative deflection observed approximately 45 ms after the TMS input.
Local mean field amplitude-area under the curve (LMFA-AUC)
This will be assessed by examining the TMS-evoked EEG
Anxiety
This will be assessed using the General Anxiety Disorder-7 (GAD-7) questionnaire.
Psychosocial stress
This will be assessed using the Antenatal Risk Questionnaire (ANRQ)
Post-Traumatic Stress Disorder (PTSD)
The Post-traumatic Stress Disorder Checklist for DSM-5 (PCL-5) questionnaire.
Breastfeeding success
Success in any 24-hour period will be defined as when an infant breastfeeds, for 10 minutes or more in a rhythmic suck/swallow/pause/suck pattern, at least eight times in that 24-hour period.
Adverse effects - sedation
Will be assessed on a four point scale (Not present, mild, moderate, severe): sedation.
Adverse effects - Blurred vision
Will be assessed on a four point scale (Not present, mild, moderate, severe): blurred vision.
Adverse effects - diplopia
Will be assessed on a four point scale (Not present, mild, moderate, severe): diplopia.
Adverse effects - dizziness
Will be assessed on a four point scale (Not present, mild, moderate, severe): dizziness.
Adverse effects - euphoria
Will be assessed on a four point scale (Not present, mild, moderate, severe): euphoria.
Adverse effects - amnesia
Each of the following will be assessed on a four point scale (Not present, mild, moderate, severe): amnesia.
Adverse effects - hallucinations
Will be assessed on a four point scale (Not present, mild, moderate, severe): hallucinations.
Adverse effects - nystamus
Will be assessed on a four point scale (Not present, mild, moderate, severe): nystagmus.
Adverse effects
Will be assessed on a four point scale (Not present, mild, moderate, severe): sedation, blurred vision, diplopia, dizziness, euphoria, amnesia, hallucinations, nystagmus.
Antidepressant treatment
All current pharmacological and psychological therapies will be documented.

Secondary Outcome Measures

Full Information

First Posted
August 15, 2023
Last Updated
September 22, 2023
Sponsor
Washington University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT06048263
Brief Title
The Perinatal Synergistic Multi-component Intervention to alLeviate dEpressive Symptoms. A Case Series
Acronym
SMILES
Official Title
The Perinatal SMILES (Synergistic Multi-component Intervention to alLeviate dEpressive Symptoms) Case Series. Combining Ketamine and Interpersonal Psychotherapy to Improve Postpartum Mood
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 30, 2023 (Anticipated)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
August 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Washington University School of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief 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: Is it feasible to recruit a sufficient number of participants? Is it feasible to administer Perinatal SMILES and Is it feasible to collect participant outcomes? Participants will: Complete five sessions of interpersonal therapy Receive two skin injections of ketamine, approximately 24 hours apart, in the first four postpartum day Receive additional therapy sessions before (to prepare for ketamine) and after (interpersonal therapy) each ketamine injection 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 Complete mood assessments over the first 12 postpartum weeks
Detailed Description
The investigators will perform an open-label case series to evaluate the feasibility of performing a trial of a novel intervention to reduce postpartum depression symptoms after cesarean delivery. The intervention, Perinatal SMILES (Synergistic Multi-component Intervention to alLeviate dEpressive Symptoms), combines interpersonal therapy with subcutaneous ketamine therapy. The interpersonal therapy consists of five sessions that will be administered during the antepartum and/or postpartum. The ketamine therapy will be administered as two injections, approximately 24 hours apart, in the first four postpartum days and will be preceded and followed by additional therapy sessions. The investigators will assess brain electronic activity before and after the ketamine injections and mood in the first 12 postpartum weeks. The objective is to determine the feasibility of recruiting participant, administering the intervention and collect the outcome data.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postpartum Depression
Keywords
Pregnancy, Socio-economically disadvantaged, Cesarean, Postpartum depression

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention Interpersonal psychotherapy plus ketamine
Arm Type
Experimental
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
interpersonal psychotherapy (IPT)
Other Intervention Name(s)
Reach Out Stay Strong Essentials (ROSE) IPT
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Ketamine
Other Intervention Name(s)
Subcutaneous Ketamine
Intervention Description
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).
Primary Outcome Measure Information:
Title
Depressive symptoms
Description
These will be assessed using the Edinburgh Postpartum Depression Scale (EDPS) questionnaire.30 The EPDS is a set of ten questions about the subject's mood in the previous seven days. Each symptom is scored on a numeric rating scale of none (0) to severe (3). Commonly employed thresholds for psychiatric referral are 10-13 out of a possible 30 points.
Time Frame
through postoperative day 84
Title
P30 (TMS-evoked potential)
Description
This will be assessed using TMS-EEG. The amplitude of each of component positive (P) and negative (N) deflections in the evoked EEG signal will be recorded before and at 3 timepoints in the 2-10 hours after ketamine. The component deflections are named according to polarity of the deflection (N = negative, P = Positive) and the approximate time in milliseconds after the TMS input. For example N45 is the negative deflection observed approximately 45 ms after the TMS input.
Time Frame
4 days
Title
N45 (TMS-evoked potential)
Description
This will be assessed using TMS-EEG. The amplitude of each of component positive (P) and negative (N) deflections in the evoked EEG signal will be recorded before and at 3 timepoints in the 2-10 hours after ketamine. The component deflections are named according to polarity of the deflection (N = negative, P = Positive) and the approximate time in milliseconds after the TMS input. For example N45 is the negative deflection observed approximately 45 ms after the TMS input.
Time Frame
4 days
Title
P60 (TMS-evoked potential)
Description
This will be assessed using TMS-EEG. The amplitude of each of component positive (P) and negative (N) deflections in the evoked EEG signal will be recorded before and at 3 timepoints in the 2-10 hours after ketamine. The component deflections are named according to polarity of the deflection (N = negative, P = Positive) and the approximate time in milliseconds after the TMS input. For example N45 is the negative deflection observed approximately 45 ms after the TMS input.
Time Frame
4 days
Title
N100 (TMS-evoked potential)
Description
This will be assessed using TMS-EEG. The amplitude of each of component positive (P) and negative (N) deflections in the evoked EEG signal will be recorded before and at 3 timepoints in the 2-10 hours after ketamine. The component deflections are named according to polarity of the deflection (N = negative, P = Positive) and the approximate time in milliseconds after the TMS input. For example N45 is the negative deflection observed approximately 45 ms after the TMS input.
Time Frame
4 days
Title
Local mean field amplitude-area under the curve (LMFA-AUC)
Description
This will be assessed by examining the TMS-evoked EEG
Time Frame
4 days
Title
Anxiety
Description
This will be assessed using the General Anxiety Disorder-7 (GAD-7) questionnaire.
Time Frame
through postoperative day 84
Title
Psychosocial stress
Description
This will be assessed using the Antenatal Risk Questionnaire (ANRQ)
Time Frame
at enrollment 1 day
Title
Post-Traumatic Stress Disorder (PTSD)
Description
The Post-traumatic Stress Disorder Checklist for DSM-5 (PCL-5) questionnaire.
Time Frame
through postoperative day 84
Title
Breastfeeding success
Description
Success in any 24-hour period will be defined as when an infant breastfeeds, for 10 minutes or more in a rhythmic suck/swallow/pause/suck pattern, at least eight times in that 24-hour period.
Time Frame
4 days
Title
Adverse effects - sedation
Description
Will be assessed on a four point scale (Not present, mild, moderate, severe): sedation.
Time Frame
4 days
Title
Adverse effects - Blurred vision
Description
Will be assessed on a four point scale (Not present, mild, moderate, severe): blurred vision.
Time Frame
4 days
Title
Adverse effects - diplopia
Description
Will be assessed on a four point scale (Not present, mild, moderate, severe): diplopia.
Time Frame
4 days
Title
Adverse effects - dizziness
Description
Will be assessed on a four point scale (Not present, mild, moderate, severe): dizziness.
Time Frame
4 days
Title
Adverse effects - euphoria
Description
Will be assessed on a four point scale (Not present, mild, moderate, severe): euphoria.
Time Frame
4 days
Title
Adverse effects - amnesia
Description
Each of the following will be assessed on a four point scale (Not present, mild, moderate, severe): amnesia.
Time Frame
4 days
Title
Adverse effects - hallucinations
Description
Will be assessed on a four point scale (Not present, mild, moderate, severe): hallucinations.
Time Frame
4 days
Title
Adverse effects - nystamus
Description
Will be assessed on a four point scale (Not present, mild, moderate, severe): nystagmus.
Time Frame
4 days
Title
Adverse effects
Description
Will be assessed on a four point scale (Not present, mild, moderate, severe): sedation, blurred vision, diplopia, dizziness, euphoria, amnesia, hallucinations, nystagmus.
Time Frame
4 days
Title
Antidepressant treatment
Description
All current pharmacological and psychological therapies will be documented.
Time Frame
through postoperative day 84

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Must be >20 weeks pregnant
Accepts Healthy Volunteers
No
Eligibility Criteria
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) -> 20 - 32 weeks pregnant and 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
David Monks, MBCHB
Phone
314-323-1845
Email
dmonks@wustl.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Haley Bernstein
Phone
314-747-6073
Email
bernstein.h@wustl.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Monks, MBCHB
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Barnes-Jewish Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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