No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
60 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Basic Science
Participants needed
70 (estimated)
Sponsor
Washington University School of Medicine · Other
Who this trial is looking for
This trial is looking for older adults aged 60 and over who are experiencing depression. Participants will receive propofol infusions and behavioral therapy to see if these treatments improve their sleep and mood.
Are You a Good Fit for This Trial?
You may be able to join if
I am 60 years of age or older.
I speak English.
I have been diagnosed with depression that hasn't improved with antidepressants.
I am willing to follow all the study procedures.
I can provide signed consent to participate.
You may not be able to join if
I have heart disease or severe heart failure.
I have had a bad reaction to propofol before.
I have a resting heart rate below 50 bpm.
I have taken Electroconvulsive Therapy or Transcranial Magnetic Stimulation in the past 6 weeks.
My body mass index is over 35.
I have active suicidal thoughts or a specific plan.
I have dementia.
I have schizophrenia or bipolar disorder.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 …
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.
Trial Locations
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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 conv…
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.
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