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RecruitingPhase 2

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
60 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 6 weeks
  • Procedures mentioned: Infusions, Pills

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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)."
  • "Through personalized infusions targeting electroencephalographic (EEG) patterns, the investigators aim for a systematic characterization of the relationships between the propofol (dose and EEG measures) and enhancement of slow wave sleep, with associated secondary clinical and cognitive outcomes."
  • "Two BBTI sessions will be administered before the propofol infusions, with two additional sessions within 6 weeks after the 2nd infusion."
  • "Propofol will be infused through a peripheral IV, with the assistance of target-controlled infusion software and pumps, with an anticipated infusion duration of 2 hours."
  • "The device, charger, tablet, and instructional materials will be provided to patients."
  • "Additionally, recordings will be obtained for up to 6 weeks after the final infusion, to evaluate persistence of restoration of sleep architecture."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether propofol, a drug used for anesthesia, plus brief sleep therapy can improve deep sleep, depression, and thinking. It is for adults age 60 or older whose depression has not improved with at least one antidepressant treatment. Participants get two propofol infusions at a low or moderate dose and 3–4 sleep therapy sessions.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 60 or older.
  • Speak English.
  • Have depression that has not improved after at least one adequate trial of an antidepressant taken by mouth for the current episode.
  • Sign and date a form agreeing to join the study.
  • Be willing to follow all study steps and available for the whole study.

Who can't join

  • Have heart artery disease with symptoms, serious heart failure or heart muscle disease, or a resting heart rate below 50 beats per minute.
  • Have had a reaction to propofol or received anesthesia in the past 4 weeks.
  • Have received electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS), or vagus nerve stimulation within 6 weeks. These treatments use electricity or magnets to stimulate the brain or nerves.
  • Have a body mass index (BMI), a measure based on height and weight, above 35.
  • Have active thoughts of suicide with some intent to act, whether or not there is a plan, with a suicide screening score of 4 or higher.
  • Have a MoCA memory and thinking test score below 23, or have schizophrenia or bipolar disorder.
  • Use amphetamines, opioids, cocaine, or PCP without a prescription; have a urine THC level above 150 ng/ml; or drink more than 14 beers a week or the same amount of alcohol in other drinks. THC is a chemical in cannabis.
  • Currently take more than 2 mg a day of lorazepam or an equal dose of another benzodiazepine, more than 50 mg a day of trazodone, or more than 600 mg a day of gabapentin.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (1)

MO