The Perinatal Synergistic Multi-component Intervention to alLeviate dEpressive Symptoms. A Case Series : The Perinatal SMILES (Synergistic Multi-component Intervention to alLeviate dEpressive Symptoms) Case Series. Combining Ketamine and Interpersonal Psychotherapy to Improve Postpartum Mood
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..
| Medienart: |
|
|---|
Klinische Studie| Erscheinungsjahr: |
2024 |
|---|---|
| Erschienen: |
2024 |
| Enthalten in: |
ClinicalTrials.gov - (2024) vom: 27. März Zur Gesamtaufnahme - year:2024 |
|---|
| Sprache: |
Englisch |
|---|
| Links: |
Volltext [kostenfrei] |
|---|
| Themen: |
610 |
|---|
| Anmerkungen: |
Source: Link to the current ClinicalTrials.gov record., First posted: September 21, 2023, Last downloaded: ClinicalTrials.gov processed this data on April 03, 2024, Last updated: April 03, 2024 |
|---|
| Study ID: |
NCT06048263 |
|---|---|
| Veröffentlichungen zur Studie: |
|
| fisyears: |
|
|---|---|
| Förderinstitution / Projekttitel: |
|
| PPN (Katalog-ID): |
CTG000046698 |
|---|
| LEADER | 01000caa a22002652 4500 | ||
|---|---|---|---|
| 001 | CTG000046698 | ||
| 003 | DE-627 | ||
| 005 | 20240403010505.0 | ||
| 007 | cr uuu---uuuuu | ||
| 008 | 240313s2024 xx |||||o 00| ||eng c | ||
| 035 | |a (DE-627)CTG000046698 | ||
| 035 | |a (UBBS_Klinische_Studien)NCT06048263 | ||
| 035 | |a (UBBS_Klinische_Studien)202306156 | ||
| 040 | |a DE-627 |b ger |c DE-627 |e rakwb | ||
| 041 | |a eng | ||
| 245 | 1 | 0 | |a The Perinatal Synergistic Multi-component Intervention to alLeviate dEpressive Symptoms. A Case Series |b The Perinatal SMILES (Synergistic Multi-component Intervention to alLeviate dEpressive Symptoms) Case Series. Combining Ketamine and Interpersonal Psychotherapy to Improve Postpartum Mood |
| 264 | 1 | |c 2024 | |
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a Computermedien |b c |2 rdamedia | ||
| 338 | |a Online-Ressource |b cr |2 rdacarrier | ||
| 500 | |a Source: Link to the current ClinicalTrials.gov record., First posted: September 21, 2023, Last downloaded: ClinicalTrials.gov processed this data on April 03, 2024, Last updated: April 03, 2024 | ||
| 520 | |a 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. | ||
| 650 | 2 | |a Depression, Postpartum | |
| 650 | 2 | |a Depression | |
| 650 | 4 | |a Study Type: Interventional | |
| 650 | 4 | |a Recruitment Status: Not yet recruiting | |
| 650 | 4 | |a Phase: Phase 2, Phase 3 | |
| 650 | 4 | |a 610 | |
| 773 | 0 | 8 | |i Enthalten in |t ClinicalTrials.gov |g (2024) vom: 27. März |
| 773 | 1 | 8 | |g year:2024 |g day:27 |g month:03 |
| 856 | 4 | 0 | |u https://clinicaltrials.gov/show/NCT06048263 |z kostenfrei |3 Volltext |
| 912 | |a GBV_CTG | ||
| 951 | |a AR | ||
| 952 | |j 2024 |b 27 |c 03 | ||