DepressionPhase 2SWIPED IINCT06867549
Slow Wave Induction by Propofol to Eliminate Depression (SWIPED) Stage II
A Phase 2 study testing Propofol, Electroencephalography (EEG) and Brief Behavioral Therapy for Insomnia in people with Depression, run by Washington University School of Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Depression
- What is being tested?
- Propofol, Electroencephalography (EEG) and Brief Behavioral Therapy for Insomnia
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Mar 2025to 1 May 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Show all 14Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Washington University School of Medicine/Barnes-Jewish Hospital
St Louis, Missouri, 63110
Sarah E Knarr, 314-362-2415, knarr.sarah@wustl.edu
Ben Palanca, MD PhD
About this study
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.
Read the detailed description
Depression in older adults is a leading cause of disability, excess mortality from suicide, and dementia. Cognitive problems and sleep disturbances are common, contributing to recurrence and poor long-term outcomes. Disrupted slow-wave sleep is at the nexus of depression and cognitive dysfunction in older adults. Novel approaches to target this core pathophysiology are lacking. This mechanistic project is designed to elucidate the relationships between TRD and sleep disturbances in older adults. 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. Through the re-purposing of propofol as a therapeutic probe, this innovative proposal will establish whether EEG slow waves are a viable therapeutic target for novel antidepressant approaches.
Two BBTI sessions will be administered before the propofol infusions, with two additional sessions within 6 weeks after the 2nd infusion. The sessions will completed remotely or in person.
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. Concurrent high-density EEG will be acquired. Participants will be discharged home after nurse monitoring and fulfillment of post-anesthetic care unit criteria.
Patients will be instructed by staff on the operation of the SOMNOmedics HST for at-home overnight sleep EEG recordings. Patients will demonstrate the ability to successfully wear the device and initiate recordings without assistance. The device, charger, tablet, and instructional materials will be provided to patients.
Overnight sleep recordings will be obtained prior to the first propofol infusion and on evenings of propofol infusions. Additionally, recordings will be obtained for up to 6 weeks after the final infusion, to evaluate persistence of restoration of sleep architecture.
Primary endpoints will be analyzed based on age, sex, time separating propofol infusions, induction of EEG measures during infusions, pharmacokinetic exposure times at varying concentrations, adherence to BBTI, and concomitant medications.
- Conditions
- Depression
- Being tested
- Propofol, Electroencephalography (EEG), Brief Behavioral Therapy for Insomnia
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropofolDrug
Also called anesthetic
Targeted propofol infusion in TRD patients will induce sedation. Dosage of propofol is determined based upon EEG markers and treatment arm.
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.
Brief Behavioral Therapy for InsomniaBehavioural
Also called BBTI
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Propofol; Diagnostic Test: Electroencephalography (EEG); Behavioral: Brief Behavioral Therapy for Insomnia |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Pre-infusion and on the nights of propofol infusions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2025
- Study start4 Mar 2025
- Primary completion1 Apr 2028 (estimated)
- Study completion1 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-blinded randomized controlled trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Ben J.A. Palanca, Washington University School of Medicine
- Investigators
- Ben Palanca, MD PhD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06867549
- Sponsor's protocol ID
- 202411168
- Other IDs
- U01MH128483
- Acronym
- SWIPED II
- Status last verified
- Aug 2026
- First submitted
- 25 Feb 2025
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study protocol will be released in manuscript form. Outcome data will be uploaded to the NIMH Data Archive on a rolling basis. EEG data will be shared via the National Sleep Research Resource within three years of study completion.
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Slow Wave Induction by Propofol to Eliminate Depression (SWIPED) Stage II
- ClinicalTrials.gov ID
- NCT06867549
- Acronym / sponsor ID
- SWIPED II / 202411168
- Conditions
- Depression
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 4 Mar 2025 (actual)
- Primary completion
- 1 Apr 2028 (estimated)
- Study completion
- 1 May 2028 (estimated)
- First posted
- 10 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Depression in older adults is a leading cause of disability, excess mortality from suicide, and dementia. Cognitive problems and sleep disturbances are common, contributing to recurrence and poor long-term outcomes. Disrupted slow-wave sleep is at the nexus of depression and cognitive dysfunction in older adults. Novel approaches to target this core pathophysiology are lacking. This mechanistic project is designed to elucidate the relationships between TRD and sleep disturbances in older adults. 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. Through the re-purposing of propofol as a therapeutic probe, this innovative proposal will establish whether EEG slow waves are a viable therapeutic target for novel antidepressant approaches.
Two BBTI sessions will be administered before the propofol infusions, with two additional sessions within 6 weeks after the 2nd infusion. The sessions will completed remotely or in person.
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. Concurrent high-density EEG will be acquired. Participants will be discharged home after nurse monitoring and fulfillment of post-anesthetic care unit criteria.
Patients will be instructed by staff on the operation of the SOMNOmedics HST for at-home overnight sleep EEG recordings. Patients will demonstrate the ability to successfully wear the device and initiate recordings without assistance. The device, charger, tablet, and instructional materials will be provided to patients.
Overnight sleep recordings will be obtained prior to the first propofol infusion and on evenings of propofol infusions. Additionally, recordings will be obtained for up to 6 weeks after the final infusion, to evaluate persistence of restoration of sleep architecture.
Primary endpoints will be analyzed based on age, sex, time separating propofol infusions, induction of EEG measures during infusions, pharmacokinetic exposure times at varying concentrations, adherence to BBTI, and concomitant medications.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Double-blinded randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Propofol infusion -moderate dose | Experimental | Drug: Propofol, Diagnostic Test: Electroencephalography (EEG), Behavioral: Brief Behavioral Therapy for InsomniaSerial 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. |
| Propofol infusion - low dose | Active comparator | Drug: Propofol, Diagnostic Test: Electroencephalography (EEG), Behavioral: Brief Behavioral Therapy for InsomniaSerial 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PropofolAlso: anestheticTargeted propofol infusion in TRD patients will induce sedation. Dosage of propofol is determined based upon EEG markers and treatment arm. | Drug | Propofol infusion - low dose, Propofol infusion -moderate dose |
| 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. | Diagnostic test | Propofol infusion - low dose, Propofol infusion -moderate dose |
| Brief Behavioral Therapy for InsomniaAlso: BBTITrained 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. | Behavioural | Propofol infusion - low dose, Propofol infusion -moderate dose |
Primary outcome
Change in SWS duration
Time frame: Pre-infusion and on the nights of propofol infusions
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
- Individual participant dataSharing planned: Yes. Study protocol will be released in manuscript form. Outcome data will be uploaded to the NIMH Data Archive on a rolling basis. EEG data will be shared via the National Sleep Research Resource within three years of study completion.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ben Palanca, MD PhD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Propofol, Electroencephalography (EEG) and Brief Behavioral Therapy for Insomnia in people with Depression, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sarah E Knarr (314-362-2415, knarr.sarah@wustl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in SWS duration (time frame: Pre-infusion and on the nights of propofol infusions). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2026.