Postpartum DepressionPhase 2/3SMILESNCT06048263
The Perinatal Synergistic Multi-component Intervention to alLeviate dEpressive Symptoms. A Case Series
A Phase 2/3 study testing interpersonal psychotherapy (IPT) and Ketamine in people with Postpartum Depression, run by Washington University School of Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Postpartum Depression
- What is being tested?
- interpersonal psychotherapy (IPT) and Ketamine
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2025to 15 Oct 2025
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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 join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Perinatal SMILES (Synergistic Multi-component Intervention to alLeviate dEpressive Symptoms) Case Series. Combining Ketamine and Interpersonal Psychotherapy to Improve Postpartum Mood
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:
Read more
- 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?
To profile EEG in participants at rest and in response to TMS, before and after subcutaneous ketamine
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
Read the 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.
- Conditions
- Postpartum Depression
- Being tested
- interpersonal psychotherapy (IPT), Ketamine
- Keywords
- Pregnancy, Socio-economically disadvantaged, Cesarean, Postpartum depression
- Medical subject headings
- Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
interpersonal psychotherapy (IPT)Behavioural
Also called Reach Out Stay Strong Essentials (ROSE) 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.
KetamineDrug
Also called Subcutaneous 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).
| Study group | Role | What they receive |
|---|---|---|
| Intervention Interpersonal psychotherapy plus ketamine | Experimental | 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 Receives: Behavioral: interpersonal psychotherapy (IPT); Drug: Ketamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: through postoperative day 84
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.
Measured: 4 days
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.
Measured: 4 days
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.
Measured: 4 days
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.
Measured: 4 days
Cortical evoked activity (CEA)
The CEA will be calculated from the area under the curve of the rectified single pulse TMS-evoked potential
Measured: 4 days
Anxiety
This will be assessed using the General Anxiety Disorder-7 (GAD-7) questionnaire. There are 7 items scored from 0-3. The total score can range from 0 (no anxiety) - 21 (most anxiety).
Measured: through postoperative day 84
Psychosocial stress
This will be assessed using the Antenatal Risk Questionnaire (ANRQ). The range of scores is 5-60. A higher score indicates greater psychosocial risk.
Measured: at enrollment 1 day
Post-Traumatic Stress Disorder (PTSD)
The Post-traumatic Stress Disorder Checklist for DSM-5 (PCL-5) questionnaire. Scores range 0 - 80. More severe PTSD scores higher.
Measured: through postoperative day 84
Obstetric Quality of Recovery
(ObsQoR10 score, 10 items, total score 0-100)
Measured: through postoperative day 84
Number of participants who successfully breastfeed their newborn baby
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.
Measured: 4 days
Adverse effects - sedation
Will be assessed on a four point scale (Not present, mild, moderate, severe): sedation.
Measured: 4 days
Adverse effects - Blurred vision
Will be assessed on a four point scale (Not present, mild, moderate, severe): blurred vision.
Measured: 4 days
Adverse effects - diplopia
Will be assessed on a four point scale (Not present, mild, moderate, severe): diplopia.
Measured: 4 days
Adverse effects - dizziness
Will be assessed on a four point scale (Not present, mild, moderate, severe): dizziness.
Measured: 4 days
Adverse effects - euphoria
Will be assessed on a four point scale (Not present, mild, moderate, severe): euphoria.
Measured: 4 days
Adverse effects - amnesia
Each of the following will be assessed on a four point scale (Not present, mild, moderate, severe): amnesia.
Measured: 4 days
Adverse effects - hallucinations
Will be assessed on a four point scale (Not present, mild, moderate, severe): hallucinations.
Measured: 4 days
Adverse effects - nystamus
Will be assessed on a four point scale (Not present, mild, moderate, severe): nystagmus.
Measured: 4 days
Antidepressant treatment
All current pharmacological and psychological therapies will be documented.
Measured: through postoperative day 84
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start15 Oct 2025
- Primary completion15 Oct 2025
- Study completion15 Oct 2025
Why it stopped: PI is leaving the university
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum DepressionStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Monks, Washington University School of Medicine
- Investigators
- David Monks, MBCHB, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06048263
- Sponsor's protocol ID
- 202306156
- Acronym
- SMILES
- Status last verified
- Oct 2025
- First submitted
- 15 Aug 2023
- Last updated
- 29 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Perinatal SMILES (Synergistic Multi-component Intervention to alLeviate dEpressive Symptoms) Case Series. Combining Ketamine and Interpersonal Psychotherapy to Improve Postpartum Mood
- ClinicalTrials.gov ID
- NCT06048263
- Acronym / sponsor ID
- SMILES / 202306156
- Conditions
- Postpartum Depression
- Keywords
- Pregnancy, Socio-economically disadvantaged, Cesarean, Postpartum depression
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI is leaving the university
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 15 Oct 2025 (actual)
- Primary completion
- 15 Oct 2025 (actual)
- Study completion
- 15 Oct 2025 (actual)
- First posted
- 21 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
To profile EEG in participants at rest and in response to TMS, before and after subcutaneous ketamine
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention Interpersonal psychotherapy plus ketamine | Experimental | Behavioral: interpersonal psychotherapy (IPT), Drug: KetamineFive 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 may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| interpersonal psychotherapy (IPT)Also: Reach Out Stay Strong Essentials (ROSE) IPTThe 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. | Behavioural | Intervention Interpersonal psychotherapy plus ketamine |
| KetamineAlso: Subcutaneous KetamineDuring 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). | Drug | Intervention Interpersonal psychotherapy plus ketamine |
Primary outcome
Depressive symptoms
Time frame: through postoperative day 84
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)
Time frame: 4 days
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)
Time frame: 4 days
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)
Time frame: 4 days
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)
Time frame: 4 days
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.
Cortical evoked activity (CEA)
Time frame: 4 days
The CEA will be calculated from the area under the curve of the rectified single pulse TMS-evoked potential
Anxiety
Time frame: through postoperative day 84
This will be assessed using the General Anxiety Disorder-7 (GAD-7) questionnaire. There are 7 items scored from 0-3. The total score can range from 0 (no anxiety) - 21 (most anxiety).
Psychosocial stress
Time frame: at enrollment 1 day
This will be assessed using the Antenatal Risk Questionnaire (ANRQ). The range of scores is 5-60. A higher score indicates greater psychosocial risk.
Post-Traumatic Stress Disorder (PTSD)
Time frame: through postoperative day 84
The Post-traumatic Stress Disorder Checklist for DSM-5 (PCL-5) questionnaire. Scores range 0 - 80. More severe PTSD scores higher.
Obstetric Quality of Recovery
Time frame: through postoperative day 84
(ObsQoR10 score, 10 items, total score 0-100)
Number of participants who successfully breastfeed their newborn baby
Time frame: 4 days
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
Time frame: 4 days
Will be assessed on a four point scale (Not present, mild, moderate, severe): sedation.
Adverse effects - Blurred vision
Time frame: 4 days
Will be assessed on a four point scale (Not present, mild, moderate, severe): blurred vision.
Adverse effects - diplopia
Time frame: 4 days
Will be assessed on a four point scale (Not present, mild, moderate, severe): diplopia.
Adverse effects - dizziness
Time frame: 4 days
Will be assessed on a four point scale (Not present, mild, moderate, severe): dizziness.
Adverse effects - euphoria
Time frame: 4 days
Will be assessed on a four point scale (Not present, mild, moderate, severe): euphoria.
Adverse effects - amnesia
Time frame: 4 days
Each of the following will be assessed on a four point scale (Not present, mild, moderate, severe): amnesia.
Adverse effects - hallucinations
Time frame: 4 days
Will be assessed on a four point scale (Not present, mild, moderate, severe): hallucinations.
Adverse effects - nystamus
Time frame: 4 days
Will be assessed on a four point scale (Not present, mild, moderate, severe): nystagmus.
Antidepressant treatment
Time frame: through postoperative day 84
All current pharmacological and psychological therapies will be documented.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Monks, MBCHB principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing interpersonal psychotherapy (IPT) and Ketamine in people with Postpartum Depression, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 29 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depressive symptoms (time frame: through postoperative day 84). The study lists 20 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2025.