Slow Wave Induction by Propofol to Eliminate Depression (SWIPED) - Phase I

• Status: Recruiting
• Trial end date: 2023-08-01
• Target enrollment: 0
• Participant gender: All

Summary

Our overall hypothesis is that sleep slow-wave potentiation by propofol is a therapeutic pathway for alleviating treatment-resistant depression (TRD).

This investigation aims to establish:

Aim 1: Establish the safety and feasibility of multiple propofol infusions targeting of electroencephalographic (EEG) slow-wave activity (SWA) without burst suppression in geriatric patients with treatment-resistant depression (TRD) patients.

Prospective, mechanistic, open-label for safety/feasibility pilot study (target enrollment = 15)

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Washington University School of Medicine
• Treatments: Propofol

Criteria

Inclusion Criteria:

• Age 60 or older

• history of treatment-resistant depression (failure of two oral antidepressant classes)

• baseline deficiency in N3 sleep

Exclusion Criteria:

• Symptomatic coronary artery disease

• congestive heart failure or cardiomyopathy

• history of TIA or cognitive symptoms in the past year

• allergy to propofol

• pulse<60 bpm at baseline

• concurrent/recent (within 6 weeks) neuromodulatory stimulation for depression (ECT/TMS)

• Body mass index (BMI) > 35