The Perinatal Synergistic Multi-component Intervention to alLeviate dEpressive Symptoms. A Case Series
A legfontosabb adatok
- Ki végzi
- Washington University School of Medicine
- Hol
- St Louis (Egyesült Államok)A helyszín megnézése
- Azonosító
- Állapot
- Visszavonva
- Fázis
- 2/3. fázis
- Kezdés
- 2025. okt. 15.
- Befejezés
- 2025. okt. 15.
- A vizsgálat típusa
- Beavatkozással járó
- A vizsgált kezelések
- interpersonal psychotherapy (IPT)
- Ketamine
- A regiszteradat frissítve
- 2025. október 29.
- Miért állt le
- PI is leaving the university
Ki vehet részt
- Nem
- Csak nők
- Egészséges önkéntesek
- Nem vehetnek részt
A regiszter feltételei, szó szerint
Mind a 5 feltétel megnézéseKevesebb
Ki vehet részt
- 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
Ki nem vehet részt
- 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
Helyszínek itt: Egyesült Államok
- Barnes-Jewish HospitalSt Louis, Egyesült Államok
A vizsgálatról
Mit akar kideríteni a vizsgálat
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.
A teljes eredeti leírásKevesebb
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
A vizsgálat csoportja
- Intervention Interpersonal psychotherapy plus ketamineA vizsgált kezelés
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
Kezelés: interpersonal psychotherapy (IPT) és Ketamine
Adatok és források
- Regiszteradat
- Szerepel a ClinicalTrials.gov-on.
- Hivatalos cím
- The Perinatal SMILES (Synergistic Multi-component Intervention to alLeviate dEpressive Symptoms) Case Series. Combining Ketamine and Interpersonal Psychotherapy to Improve Postpartum Mood
- A regiszteradat frissítve
- 2025. október 29.