Using propofol to improve sleep and reduce depression in older adults

Slow Wave Induction by Propofol to Eliminate Depression (SWIPED) Stage II

This study is testing if using propofol to improve sleep, along with short therapy sessions, can help older adults feel less depressed.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 70 (estimated)
• Ages: 60 Years and up
• Sex: All
• Sponsor: Washington University School of Medicine (Academic / other)
• Locations: 1 site (St Louis, Missouri)
• Trial ID: NCT06867549 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effects of targeted propofol infusion combined with brief behavioral therapy on sleep and depression in geriatric patients. The study will enroll 70 participants who will receive either low or moderate doses of propofol to enhance slow wave sleep, with EEG monitoring to assess brain activity. Participants will also undergo several sessions of Brief Behavioral Therapy for Insomnia to support their treatment. The goal is to determine if improving sleep can lead to better clinical and cognitive outcomes for older adults suffering from depression.

Who should consider this trial

Good fit: Ideal candidates for this study are English-speaking adults aged 60 and older who have depression that has not responded to at least one adequate trial of oral antidepressants.

Not a fit: Patients with significant heart conditions, prior adverse reactions to propofol, or those currently undergoing other intensive treatments for depression may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a novel treatment option for older adults with treatment-resistant depression by improving their sleep quality and overall mental health.

How similar studies have performed: While the approach of using propofol in this context is innovative, similar studies targeting sleep disturbances in depression have shown promise, suggesting potential for success.

Eligibility criteria

Inclusion Criteria:

* Provision of signed and dated informed consent form
* Stated willingness to comply with all study procedures and availability for the duration of the study
* Age 60 or greater
* English speaking (as an interpreter will not be readily available should a participant need to convey any safety concerns during the propofol infusion sessions or require guidance on conducting at-home sleep recordings)
* Depression (non-responsive to at least one adequate trial of oral antidepressants for current episode).

Exclusion Criteria:

* Presence of symptomatic coronary artery disease
* Presence of marked congestive heart failure/cardiomyopathy(NYHA \> Class III, LVEF \<40%, greater than mild RV systolic dysfunction)
* Prior reaction to propofol
* Resting heart rate \< 50 bpm
* Treatment with Electroconvulsive therapy/Transcranial Magnetic Stimulation/vagal nerve stimulation within 6 weeks
* Body mass index \> 35
* C-SSRS of 4 or greater (active suicidal ideation with some intent and with/without a specific plan)
* MoCA score \< 23 (at least mild dementia)
* Schizophrenia
* Bipolar disorder
* Non-prescribed use of amphetamines, opioids, cocaine, or phencyclidine; Urine THC \> 150 ng/ml
* Intake of \> 14 beers/week (or equivalent)
* Anesthetic exposure in the past 4 weeks
* Concurrent use of benzodiazepines \> 2 mg/day lorazepam or equivalent, trazodone \> 50 mg/day, or gabapentin \> 600mg/day.

Where this trial is running

St Louis, Missouri

• Washington University School of Medicine/Barnes-Jewish Hospital — St Louis, Missouri, United States (Recruiting)

Study contacts

• Principal investigator: Ben Palanca, MD PhD — Washington University School of Medicine
• Study coordinator: Sarah E Knarr

Conditions Depression