20 Participants Needed

Psilocybin for Depression in Alzheimer's

HJ
Overseen ByHillary Jackson
Age: 18+
Sex: Any
Travel: May Be Covered
Trial Phase: Phase < 1
Sponsor: Johns Hopkins University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 2 JurisdictionsThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

This trial tests if psilocybin, a substance from certain mushrooms, can safely improve depression and quality of life in people with early Alzheimer's or Mild Cognitive Impairment. It works by changing brain activity related to mood. Psilocybin has been studied for its potential to reduce depression and anxiety, particularly in patients with life-threatening conditions.

Will I have to stop taking my current medications?

You may need to stop certain medications. You can continue taking acetylcholinesterase inhibitors, SSRIs, SNRIs, and bupropion if they have been stable for a while. However, you cannot take antipsychotics, MAO inhibitors, or other antidepressants, and you must avoid certain medications like sildenafil within 72 hours of psilocybin administration.

What data supports the effectiveness of the drug psilocybin for depression in Alzheimer's patients?

Research shows that psilocybin has been effective in reducing symptoms of depression in various psychiatric disorders, including major depressive disorder, with patients experiencing significant improvements even after just a few sessions. While specific data for Alzheimer's patients is limited, these findings suggest potential benefits for depression in this group as well.12345

Is psilocybin safe for use in humans?

Psilocybin has been studied in healthy adults with escalating doses, showing a safety profile that is generally well-tolerated. However, it can cause rapid effects on the central nervous system, such as hallucinations and physical symptoms like ataxia (loss of control of body movements). While some studies suggest it may be safe under controlled conditions, caution is advised, especially in people with heart conditions.56789

How is the drug psilocybin unique in treating depression in Alzheimer's patients?

Psilocybin is unique because it acts quickly and can provide long-lasting relief from depression symptoms with just one or two doses, unlike traditional antidepressants that often require daily use. It works by activating serotonin receptors in the brain, which can lead to improved mood and well-being.14101112

Research Team

AG

Albert Garcia-Romeu, MD

Principal Investigator

Johns Hopkins University

Eligibility Criteria

This trial is for people with mild cognitive impairment or early Alzheimer's who are currently depressed. Participants must be able to commit to several long treatment sessions in Baltimore, MD, and have a close friend or family member involved in the study. Exclusions include severe mental health conditions, certain cardiovascular issues, insulin-dependent diabetes, and those on specific medications.

Inclusion Criteria

I have been diagnosed with Alzheimer's or Mild Cognitive Impairment.
I can attend long treatment sessions in Baltimore and follow-up meetings.
I am currently experiencing a depressive episode.
See 2 more

Exclusion Criteria

You have been diagnosed with schizophrenia, a psychotic disorder (unless it was caused by drugs or a medical condition), or bipolar I disorder in the past or currently.
I have tried various treatments for my current depressive episode, including psychotherapy, medications, and possibly ECT.
I agree not to take medications like sildenafil within 72 hours before taking psilocybin.
See 17 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive an 8-week course of study treatment including weekly psychological support and two psilocybin sessions

8 weeks
Weekly visits for psychological support, 2 psilocybin sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Treatment Details

Interventions

  • Psilocybin
Trial OverviewThe trial is testing psilocybin's safety and effectiveness for treating depression in individuals with mild cognitive impairment or early Alzheimer's Disease. It aims to see if it can also improve their quality of life.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: PsilocybinExperimental Treatment1 Intervention
Participants will complete an 8-week course of study treatment including weekly psychological support and two moderate to high dose psilocybin administrations in weeks 4 and 6.

Psilocybin is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as Psilocybin for:
  • Treatment-resistant depression (TRD) under Breakthrough Therapy designation
🇪🇺
Approved in European Union as Psilocybin for:
  • Treatment-resistant depression (TRD) under PRIME designation

Find a Clinic Near You

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials
2,366
Recruited
15,160,000+

Council On Spiritual Practices

Collaborator

Trials
1
Recruited
20+

Heffter Research Institute

Collaborator

Trials
15
Recruited
520+

Findings from Research

Psilocybin, a serotonergic psychedelic, has shown promise in treating various psychiatric disorders, including depression and substance use disorders, with 9 clinical trials conducted between 2000 and 2020.
The treatment is generally well tolerated with limited side effects, and some patients with treatment-resistant conditions have experienced significant long-term improvements after just a few sessions, indicating its potential efficacy.
[Treatment with psilocybin: applications for patients with psychiatric disorders].Breeksema, JJ., Koolen, MHB., Somers, M., et al.[2021]
In a study of 27 patients with moderate to severe major depressive disorder, psilocybin-assisted treatment showed significant and lasting antidepressant effects, with 75% of participants experiencing a treatment response and 58% achieving remission after 12 months.
There were no serious adverse events related to psilocybin, indicating a favorable safety profile, and participants reported meaningful personal and spiritual experiences that correlated with increased well-being, although these did not directly predict improvements in depression.
Efficacy and safety of psilocybin-assisted treatment for major depressive disorder: Prospective 12-month follow-up.Gukasyan, N., Davis, AK., Barrett, FS., et al.[2022]
Psilocybin shows promising effects in alleviating anxiety, depression, and emotional distress in palliative care patients, with a favorable safety profile, based on recent studies and reports.
Despite its potential benefits, psilocybin is not yet approved for therapeutic use in the U.S., and significant barriers exist for access, particularly for vulnerable populations like the elderly and those in palliative care.
Psilocybin in Palliative Care: An Update.Whinkin, E., Opalka, M., Watters, C., et al.[2023]

References

[Treatment with psilocybin: applications for patients with psychiatric disorders]. [2021]
Efficacy and safety of psilocybin-assisted treatment for major depressive disorder: Prospective 12-month follow-up. [2022]
Psilocybin in Palliative Care: An Update. [2023]
Assessing potential of psilocybin for depressive disorders. [2023]
The pharmacology of psilocybin. [2016]
Intravenous mushroom poisoning. [2019]
Effects and safety of Psilocybe cubensis and Panaeolus cyanescens magic mushroom extracts on endothelin-1-induced hypertrophy and cell injury in cardiomyocytes. [2021]
Pharmacokinetics of Escalating Doses of Oral Psilocybin in Healthy Adults. [2022]
[Hallucinogenic mushrooms]. [2018]
Single-dose psilocybin-assisted therapy in major depressive disorder: A placebo-controlled, double-blind, randomised clinical trial. [2023]
Psilocybin for treatment-resistant depression without psychedelic effects: study protocol for a 4-week, double-blind, proof-of-concept randomised controlled trial. [2023]
Role of psilocybin in the treatment of depression. [2020]