Propofol-Induced Sleep for Depression

Not currently recruiting at 1 trial location
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Overseen ByElliott Kraenzle
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Washington University School of Medicine
Must be taking: Antidepressants
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether the drug propofol can improve sleep patterns and reduce symptoms in people with treatment-resistant depression. Participants will receive two infusions of propofol, typically used for sedation but potentially beneficial for sleep and mood. It suits individuals over 60 who have not responded to at least two different antidepressants. The study aims to determine if propofol can enhance sleep quality, potentially alleviating depression symptoms. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to be among the first to explore its potential benefits.

Will I have to stop taking my current medications?

The trial requires that you do not use benzodiazepines over 2 mg/day, trazodone over 50 mg/day, or gabapentin over 600 mg/day. If you are taking these medications above these amounts, you may need to adjust your dosage.

Is there any evidence suggesting that propofol is likely to be safe for humans?

Research has shown that propofol, a common anesthetic, is usually well-tolerated. In a small study involving patients with treatment-resistant depression, deep propofol anesthesia was feasible and did not cause major negative effects. Another study found that propofol can be safely used to improve deep sleep. Although this trial is in its early stages and requires caution, these findings suggest that propofol might be safe for humans. However, it is important to remember that these are early results, and more research is needed to confirm its safety.12345

Why do researchers think this study treatment might be promising for depression?

Most treatments for depression, like antidepressants and psychotherapy, can take weeks to show effectiveness. But propofol, typically used as an anesthetic, has the potential to provide rapid relief by inducing deep sleep and altering brain wave activity. Researchers are excited because this approach could quickly reset brain circuits involved in depression, providing a new and fast-acting option for patients who don't respond to traditional treatments.

What evidence suggests that propofol might be an effective treatment for depression?

Research has shown that propofol, a common drug used to induce sleep during surgery, might quickly and effectively reduce depression symptoms. In this trial, participants will receive propofol infusions to explore its potential benefits for depression. One study found that six out of ten patients with treatment-resistant depression felt more than 50% better after receiving propofol. Another study reported a significant drop in depression scores, suggesting that propofol could be a promising option for those who haven't found relief with other depression therapies.13467

Who Is on the Research Team?

BP

Ben Palanca, MD

Principal Investigator

Washington University School of Medicine

Are You a Good Fit for This Trial?

This trial is for English-speaking individuals aged 60 or older with a history of treatment-resistant major depressive disorder, which means depression that hasn't improved after trying at least two different oral antidepressants. Participants must be cognitively sharp (MOCA score ≥ 23) and not have severe heart issues, propofol allergies, high suicide risk, extreme obesity (BMI ≤ 35), or current treatments like ECT/TMS or active vagal nerve implants.

Inclusion Criteria

I am 60 years old or older.
I have major depression that didn't improve with at least two different antidepressants.

Exclusion Criteria

Your body mass index (BMI) is higher than 35.
I have symptoms of heart disease.
You have a score of 4 or higher on a test called Columbia-Suicide Severity Rating Scale (C-SSRS).
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive two propofol infusions 2-6 days apart, with EEG monitoring to maximize slow wave activity

1-2 weeks
2 visits (in-person)

Follow-up

Participants are monitored for changes in sleep architecture and cognitive function using at-home EEG recordings and cognitive assessments

3 weeks
Multiple at-home recordings, 1-2 visits (in-person)

Long-term Follow-up

Participants are assessed for changes in depression, anhedonia, and suicidality up to 10 weeks after the second infusion

10 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Propofol
Trial Overview The SWIPED trial is testing whether propofol can help treat depression by inducing slow wave activity in the brain during sedation. This Phase I study involves giving participants two doses of propofol a few days apart to see if it improves their EEG slow waves and subsequent sleep quality. It's an open-label trial without placebo control conducted at Washington University Medical Center.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Propofol infusionExperimental Treatment3 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials
2,027
Recruited
2,353,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials
3,007
Recruited
2,852,000+

Published Research Related to This Trial

A study analyzing 1651 adverse event reports related to propofol from the US FDA database identified 363 significant adverse reaction signals, with anaphylactic shock, hypotension, and propofol infusion syndrome being the most common.
The findings highlight that propofol can cause a wide range of adverse reactions affecting various body systems, indicating that clinicians should exercise caution when using this anesthetic, as many reactions are not listed in the drug's official insert.
Propofol-associated serious adverse events: an analysis of the FAERS database.Xuan, G., Zhang, Y., Cui, J., et al.[2023]
Propofol is a safe and effective anesthetic agent, with induction doses of 2-2.5 mg/kg and maintenance doses of about 9 mg/kg per hour, leading to rapid and predictable emergence from anesthesia.
The use of propofol alone can significantly reduce post-induction hypotension and minimize apnea when pre-induction hyperventilation is avoided, making it a reliable choice for anesthesia without major complications.
Propofol as an intravenous agent in general anesthesia and conscious sedation.McNeir, DA., Mainous, EG., Trieger, N.[2018]
A study involving 93 depressed patients demonstrated that sleep deprivation (SD) can provide therapeutic benefits for endogenous depression, particularly in those with severe symptoms, with effects observable after at least 36 hours.
Partial sleep deprivation, which involves waking patients during the second half of the night, offers similar benefits to total sleep deprivation while being easier for patients to tolerate and implement in clinical settings.
[Total and partial sleep deprivation in the treatment of depression: preliminary communication].Schilgen, B., Bischofs, W., Blaszkiewicz, F., et al.[2006]

Citations

1.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/30260415/
Propofol for Treatment-Resistant Depression: A Pilot StudySix of the 10 subjects met the criteria for response (>50% improvement). Self-rated depression improved similarly in the propofol group and ...
Propofol for Treatment-Resistant Depression: A Pilot StudyThis study provides the first evidence suggesting that propofol, a widely available anesthetic agent, has rapid and long-lasting antidepressant effects. Future ...
Efficacy and safety of esketamine versus propofol in ...Using a non-inferiority design, the primary outcome was the reduction in HAMD-17 depressive symptoms. The other outcomes were: rates of response ...
Safety and efficacy of esketamine combined with propofol ...Secondary outcomes include the rates of response (a 50% or greater reduction in HAMD-24 total scores) and remission (a score of 8 or less in the HAMD-24 total ...
Propofol for treatment resistant depression: A randomized ...Results Treatments were well tolerated and blinding procedures were effective. The mean [95%-CI] change in HDRS-24 score was −5.3 [−10.3, −0.2] ...
Propofol enhancement of slow wave sleep to target the ...An ongoing open-label, single-arm trial that assesses the safety and feasibility of using propofol to enhance SWS in older adults with LL-TRD.
7.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/40978474/
Safety and efficacy of esketamine combined with propofol ...The present study hypothesizes that 1) adjunctive esketamine during ECT will produce greater improvement in depressive symptoms compared to placebo; 2) the ...
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