Ignite Creation Date:
2024-05-06 @ 7:33 PM
Last Modification Date:
2024-10-26 @ 3:09 PM
Study NCT ID:
NCT06048263
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-24
First Post:
2023-08-15
Brief Title:
The Perinatal Synergistic Multi-component Intervention to alLeviate dEpressive Symptoms A Case Series
Sponsor:
Washington University School of Medicine
Organization:
Washington University School of Medicine
Study Overview
Official Title:
The Perinatal SMILES Synergistic Multi-component Intervention to alLeviate dEpressive Symptoms Case Series Combining Ketamine and Interpersonal Psychotherapy to Improve Postpartum Mood
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SMILES
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
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 andor 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None