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

NCT06867549 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: 202411168U01MH128483
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Change in SWS duration

  This is the total duration of N3 averaged across infusion nights relative to baseline average. The average change in total duration of N3 infusion nights relative to baseline.

  Pre-infusion and on the nights of propofol infusions

Study Arms (2)

Propofol infusion -moderate dose

EXPERIMENTAL

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.

Drug: Propofol; Diagnostic Test: Electroencephalography (EEG); Behavioral: Brief Behavioral Therapy for Insomnia

Propofol infusion - low dose

ACTIVE COMPARATOR

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.

Drug: Propofol; Diagnostic Test: Electroencephalography (EEG); Behavioral: Brief Behavioral Therapy for Insomnia

Interventions

Propofol DRUG

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

Also known as: anesthetic

Propofol infusion - low dose; Propofol infusion -moderate dose

Electroencephalography (EEG) DIAGNOSTIC_TEST

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.

Propofol infusion - low dose; Propofol infusion -moderate dose

Brief Behavioral Therapy for Insomnia BEHAVIORAL

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.

Also known as: BBTI

Propofol infusion - low dose; Propofol infusion -moderate dose

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Washington University School of Medicine: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Washington University School of Medicine/Barnes-Jewish Hospital

St Louis, Missouri, 63110, United States

RECRUITING

MeSH Terms

Conditions

Depression

Interventions

Propofol; Anesthetics; Electroencephalography

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Central Nervous System Agents; Therapeutic Uses; Diagnostic Techniques, Neurological; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis

Study Officials

• Ben Palanca, MD PhD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarah E Knarr

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Double (Participant, Outcomes Assessor)
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Double-blinded randomized controlled trial

Study Record Dates

• First Submitted: February 25, 2025
• First Posted: March 10, 2025
• Study Start: March 4, 2025
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): April 1, 2028
• Last Updated: October 24, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Within three years of study completion.
• Access Criteria: Data use agreements may be required

Locations

US (1)