Propofol-Induced Sleep for Depression
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?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive two propofol infusions 2-6 days apart, with EEG monitoring to maximize slow wave activity
Follow-up
Participants are monitored for changes in sleep architecture and cognitive function using at-home EEG recordings and cognitive assessments
Long-term Follow-up
Participants are assessed for changes in depression, anhedonia, and suicidality up to 10 weeks after the second infusion
What Are the Treatments Tested in This Trial?
Interventions
- Propofol
Find a Clinic Near You
Who Is Running the Clinical Trial?
Washington University School of Medicine
Lead Sponsor
National Institute of Mental Health (NIMH)
Collaborator