The Perinatal Synergistic Multi-component Intervention to alLeviate dEpressive Symptoms. A Case Series (SMILES)
Open-label case series (n=25) assessing feasibility of Perinatal SMILES (interpersonal psychotherapy plus two subcutaneous ketamine doses ~24 h apart) to improve post-cesarean mood in low-income women.
Details
Open-label, single-group feasibility case series combining interpersonal psychotherapy (five sessions) with two subcutaneous ketamine injections administered in the first four post-cesarean days.
Ketamine given as 0.5 mg/kg subcutaneously with a second dose ~24 hours later (option to escalate the second dose to 0.7 mg/kg if tolerated); additional therapy sessions are provided before and after each injection.
Assessments include EEG at rest and evoked by TMS before and at multiple timepoints in the 10 hours after each injection, plus mood measures over the first 12 postpartum weeks to evaluate feasibility of recruitment, delivery, and outcome collection.