Using propofol to improve sleep and reduce depression in older adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: knarr.sarah@wustl.edu
• Phone: 314-362-2415

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.