The Perinatal Synergistic Multi-component Intervention to alLeviate

Status Not yet recruiting

Clinical 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. 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

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06048263
Study type	Interventional
Source	Washington University School of Medicine
Contact	David Monks, MBCHB
Phone	314-323-1845
Email	dmonks@wustl.edu
Status	Not yet recruiting
Phase	Phase 2/Phase 3
Start date	May 1, 2024
Completion date	April 1, 2025

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT06348316` - Early Half Swaddling and Kangaroo Care Practices on Maternal Sleep Quality and Postpartum Depression in Term Babies	N/A
Completed	`NCT05322161` - Yoga in the NICU for Parents Study	N/A
Withdrawn	`NCT03709004` - Pacifiers and Breastfeeding Among Mothers at Risk for Postpartum Depression	N/A
Completed	`NCT06305325` - Coparenting Intervention to Prevent Postpartum Depression	N/A
Not yet recruiting	`NCT05055674` - The Effects of Motherly on Postpartum Depression	N/A
Enrolling by invitation	`NCT02323152` - PREVENTION OF POSTPARTUM DEPRESSION DEVELOPMENT IN WOMEN WITH VERY HIGH RISK	N/A
Not yet recruiting	`NCT01658098` - Prevalence of Postpartum Depression in Hospital Jose E. Gonzalez	N/A
Completed	`NCT00961402` - The Effect of Exercise on Preventing PostPartum Depression	Phase 2
Completed	`NCT01312883` - Mothers Avoiding Depression Through Empowerment Intervention Trial	N/A
Completed	`NCT00360204` - Improving Health Outcomes for New Mothers and Babies	Phase 3
Unknown status	`NCT00548743` - Translating Research Into Practice for Postpartum Depression	N/A
Completed	`NCT04146025` - Nurtured in Nature	N/A
Not yet recruiting	`NCT06442774` - MamaConecta: Digital Tool for Maternal Mental Health	N/A
Recruiting	`NCT05137925` - Mindful Moms: Mechanisms of Mindfulness-based Cognitive Therapy During Pregnancy and Postpartum	N/A
Not yet recruiting	`NCT05299398` - Prevention of Postpartum Depression: A Pilot Placebo-controlled Trial of Trazodone	Phase 1
Completed	`NCT04925765` - Virtual Reality Biofeedback for Postpartum Anxiety and Depression	N/A
Recruiting	`NCT06053515` - Rosie the Chatbot: Leveraging Automated and Personalized Health Information Communication	N/A
Completed	`NCT04037085` - Ketamine to Improve Recovery After Cesarean Delivery - Part 1	Phase 2
Completed	`NCT05059600` - A Study To Assess The Safe-Use Conditions For Administration of ZULRESSO® in a Home Setting	Phase 4
Completed	`NCT06136520` - The Effect of Baby Massage Training Given to Pregnant Women on Maternal Attachment and Postpartum Depression	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms