Clinical trial NCT06048263: The Perinatal Synergistic Multi-component Intervention to alLeviate dEpressive Symptoms. A Case Series
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
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
PHASE3
Conditions: Postpartum Depression
Keywords: Pregnancy
Socio-economically disadvantaged
Cesarean
Postpartum depression
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2023-09-21
Enrollment: 25
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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:

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

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.

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) \>18 years of age \> 20 weeks pregnant 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

Primary outcomes:
measure: Depressive symptoms
timeFrame: through postoperative day 84
measure: P30 (TMS-evoked potential)
timeFrame: 4 days
measure: N45 (TMS-evoked potential)
timeFrame: 4 days
measure: P60 (TMS-evoked potential)
timeFrame: 4 days
measure: N100 (TMS-evoked potential)
timeFrame: 4 days
measure: Cortical evoked activity (CEA)
timeFrame: 4 days
measure: Anxiety
timeFrame: through postoperative day 84
measure: Psychosocial stress
timeFrame: at enrollment 1 day
measure: Post-Traumatic Stress Disorder (PTSD)
timeFrame: through postoperative day 84
measure: Obstetric Quality of Recovery
timeFrame: through postoperative day 84
measure: Number of participants who successfully breastfeed their newborn baby
timeFrame: 4 days
measure: Adverse effects - sedation
timeFrame: 4 days
measure: Adverse effects - Blurred vision
timeFrame: 4 days
measure: Adverse effects - diplopia
timeFrame: 4 days
measure: Adverse effects - dizziness
timeFrame: 4 days
measure: Adverse effects - euphoria
timeFrame: 4 days
measure: Adverse effects - amnesia
timeFrame: 4 days
measure: Adverse effects - hallucinations
timeFrame: 4 days
measure: Adverse effects - nystamus
timeFrame: 4 days
measure: Antidepressant treatment
timeFrame: through postoperative day 84
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Barnes-Jewish Hospital
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: David Monks, MBCHB
role: PRINCIPAL_INVESTIGATOR
References: