Recruiting
Phase 2

Propofol

Sponsor:

Washington University School of Medicine

Code:

NCT06867549

Conditions

Depression

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

Interventions

Propofol

Electroencephalography (EEG)

Brief Behavioral Therapy for Insomnia

Study Details

Brief summary:

The investigators hypothesize that brief behavioral therapy and targeted propofol infusion in depressed geriatric patients will augment subsequent slow wave sleep and improve clinical and cognitive outcomes. The team will recruit 70 participants for a double-blinded placebo controlled randomized controlled trial. Two propofol infusions, 2-6 days apart, will be administered, targeting either a low propofol dose arm (minimal EEG slow waves, brain effect-site concentration 1-2 mcg/ml) or moderate dose propofol arm (maximal induction of EEG slow waves, brain effect site concentration of >2.5 mcg/ml). The pharmacologic intervention will be paired with 3-4 sessions of Brief Behavioral Therapy for Insomnia for all participants. To minimize bias, there will be no specific gender or ethnic background consideration for enrollment. This will be a single site investigation at Washington University Medical Center.

Conditions

Depression

Study ID

NCT06867549

Start date

Mar 4, 2025

Status verified date

Aug, 2026

Completion date

May 1, 2028

Anticipated

Primary completion date

Apr 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

70 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Propofol infusion -moderate dose

Serial propofol infusions to maximally and safely induce unconsciousness and EEG slow waves while minimizing burst suppression. Target brain effect-site concentrations >2.5 mcg/ml. This will be paired with BBTI.

active comparator: Propofol infusion - low dose

Serial propofol infusions to safely induce unconsciousness while minimizing EEG slow waves and burst suppression.Target brain effect-site concentration of 1-2 mcg/ml. This will be paired with BBTI.

Interventions

Propofol

Targeted propofol infusion in TRD patients will induce sedation. Dosage of propofol is determined based upon EEG markers and treatment arm.

Electroencephalography (EEG)

EEG will be recorded during propofol infusion and during overnight sleep. Sleep EEG data will be acquired for a minimum of one night prior to the first sedation session, providing a baseline measure. Additional overnight sleep recordings will be performed on day of sedation and subsequent nights.

Brief Behavioral Therapy for Insomnia

Trained staff will provide evaluation and up to 3 follow up appointments of BBTI for all participants. These will be done remotely to assess behavioral approaches to improve overall sleep habits.

Primary outcome measure

  • Change in SWS duration [ Time Frame: Pre-infusion and on the nights of propofol infusions ]

Central Contacts and Locations

Central contacts

Sarah E Knarr

314-362-2415knarr.sarah@wustl.edu

Locations

Washington University School of Medicine/Barnes-Jewish Hospital

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Sarah E Knarr

314-362-2415knarr.sarah@wustl.edu

Principal Investigator:

Ben Palanca, MD PhD

More Information

Sponsor

Washington University School of Medicine

Last update posted

Aug 27, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Washington University School of Medicine on 2026-08-27.