Clinical TrialPostpartum DepressionKetamineWithdrawn

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.

Target Enrollment
25 participants
Study Type
Phase II/III interventional
Design
Non-randomized

Detailed Description

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.

Study Protocol

Preparation

2 sessions
60 min each

Dosing

2 sessions
600 min each

Integration

2 sessions
60 min each

Therapeutic Protocol

support

Study Arms & Interventions

IPT + ketamine

experimental

Five-session interpersonal psychotherapy combined with two subcutaneous ketamine injections (~24 h apart) in the first four post-cesarean days; pre- and post-ketamine therapy sessions.

Interventions

  • Compound
    via Other• multiple sessions

    Interpersonal psychotherapy (IPT)/ROSE: five sessions, first four ~60 minutes; delivered in-person or via telemedicine; additional prep/integration sessions around ketamine.

  • Ketamine0.5 - 0.7 mg/kg
    via Other• two doses• 2 doses total

    Subcutaneous (SC) ketamine 0.5 mg/kg with a second dose ~24 h later of 0.5 mg/kg or escalated to 0.7 mg/kg if no severe adverse effects.

Participants

Ages
18 – 99
Sexes
female

Inclusion Criteria

  • Inclusion Criteria
  • 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.

Exclusion Criteria

  • Exclusion Criteria
  • Allergy to ketamine
  • Contraindications for TMS including 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 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
  • 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

Study Details

  • Status
    Withdrawn
  • Phase
    Phase IIPhase III
  • Type
    interventional
  • Design
    Non-randomized
  • Target Enrollment25 participants
  • Timeline
    Start: 2024-05-01
    End: 2025-04-01
  • Compound
    Ketamine
  • Topic
    Postpartum Depression

Locations

Barnes-Jewish Hospital — St Louis, Missouri, United States

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