Psilocybin for Depression

(LIGPATD Trial)

Overseen By Matthew R Hicks, ND, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Matthew Hicks

Must not be taking: Lithium

Disqualifiers: Schizophrenia, Psychosis, Mania, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

Duration: 4 weeks

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

Due to psilocybin-assisted therapy's success in previous research, growing cultural awareness and use of psilocybin and other psychedelics, the Oregon Psilocybin Services Act passed by ballot measure in 2020 and began offering services in 2023. While the program has had many successes, a significant problem it faces is affordability and no research to date has investigated the therapy in a low-income population. Psychedelic research in recent decades has used the model of two therapists to one client to demonstrate an abundance of caution and safety to regulators, but no evidence has demonstrated this model to be safer or more effective than one with less practitioner oversight. This feasibility study would be the first investigation of Oregon Psilocybin Services as a model of care and among the first few to use a group therapy model. This study aims to test the feasibility of the model by assessing recruitment, retention, acceptability and safety of the treatment. In addition to an appropriate medical screening and intake the following questionnaire data will be collected: the Adverse Childhood Events (ACE) questionnaire, Credibility/Expectancy Questionnaire (CEQ), Hamilton Depression Inventory, PROMIS-29, Altered States of Consciousness (11-ASC) rating scale, and a survey and structured interview. Participants will consist of adults in Oregon with an income at or below 200% of the federal poverty level. Inclusion criteria will include DSM-5 diagnosis of major depression. Participants will be individually screened by a study investigator and placed into groups of five to six participants. Treatment will consist of two group preparation sessions, two psilocybin sessions, and two group integration sessions. An additional follow-up visit to collect further data will take place three months after conclusion of the treatment. The proposed study will provide valuable information for designing future clinical trials investigating the efficacy, mechanisms, and cost-effectiveness of psilocybin-assisted group therapy for depression in low-income populations.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently prescribed lithium.

Is psilocybin safe for humans?

Research shows that psilocybin, when given with psychological support, is generally safe for humans. Most side effects are mild and resolve quickly, with no serious adverse events reported in studies. ^{1 2 3 4 5}

How is the drug psilocybin different from other depression treatments?

Psilocybin is unique because it is a psychedelic compound that can rapidly reduce depression symptoms with just one or two doses, unlike traditional antidepressants that often require daily use. Its effects are linked to the activation of serotonin 2A receptors in the brain, and it is typically administered with psychological support to manage its psychedelic effects. ^{1 4 6 7 8}

What data supports the effectiveness of the drug psilocybin for depression?

Research shows that psilocybin can quickly and significantly reduce symptoms of depression, with effects lasting from one or two doses. Several studies have demonstrated its potential as a rapid-acting treatment for major depressive disorder. ^{1 4 9 10 11}

Who Is on the Research Team?

Matthew R Hicks, ND, MS

Principal Investigator

National University of Natural Medicine

Are You a Good Fit for This Trial?

This trial is for adults in Oregon with incomes at or below 200% of the federal poverty level, diagnosed with major depression. Participants must be over 21, have stable housing for six months, attend all study events, and be engaged in ongoing psychotherapy. They cannot join if they don't meet these criteria.

Inclusion Criteria

I have been diagnosed with Major Depression Disorder.

Able to read and speak fluent English

Income 200% or below the Federal Poverty Line - this is the criteria for Oregon Medicaid (OHP)

Exclusion Criteria

Active suicidal ideations or history of suicide attempts. Passive ideation, such as 'I wouldn't mind if I never woke up again' is permissible

I am currently prescribed lithium.

Any form of personality disorder

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants undergo two group preparation sessions, two psilocybin sessions, and two group integration sessions

4 weeks

6 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with data collection at a follow-up visit

3 months

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Psilocybin

Trial Overview The trial tests psilocybin-assisted group therapy's feasibility for treating depression among low-income individuals. It includes medical screening, questionnaires, two preparation sessions, two psilocybin sessions, two integration sessions and a follow-up after three months.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 Intervention

This is an uncontrolled feasibility study with only one arm.

Who Is Running the Clinical Trial?

Matthew Hicks

Lead Sponsor

Trials

1

Recruited

20+

Published Research Related to This Trial

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

A single, moderate dose of psilocybin significantly reduced depressive symptoms in 52 participants with major depressive disorder, showing a decrease of 13.0 points on the MADRS scale compared to baseline, which was significantly greater than the placebo group.

54% of participants in the psilocybin group met the criteria for remission of depression 14 days after treatment, and no serious adverse events were reported, indicating a favorable safety profile for this novel treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Single-dose psilocybin-assisted therapy in major depressive disorder: A placebo-controlled, double-blind, randomised clinical trial. von Rotz, R., Schindowski, EM., Jungwirth, J., et al.[2023]

Psilocybin has shown promise in clinical trials for reducing symptoms of depression, indicating its potential as a novel treatment option.

Patients with treatment-resistant depression (TRD) may benefit the most from psilocybin therapy, although the risks associated with its use are still not fully understood.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing potential of psilocybin for depressive disorders. Kozak, Z., Johnson, MW., Aaronson, ST.[2023]

In a placebo-controlled study involving individuals with moderate to severe major depressive disorder, psilocybin (0.3 mg/kg) showed larger antidepressant effect sizes compared to placebo, with 66.7% of participants responding and 46.7% achieving remission after treatment.

The antidepressant effects of psilocybin persisted for an average of 2 months, indicating its potential as a long-lasting treatment option for depression, although the strength of the mystical experience during dosing did not correlate with these effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psilocybin-assisted therapy for major depressive disorder: An exploratory placebo-controlled, fixed-order trial. Sloshower, J., Skosnik, PD., Safi-Aghdam, H., et al.[2023]

Psilocybin, found in 'magic mushrooms', shows promise as a non-addictive alternative for treating mental health disorders like major depressive disorder and addiction, potentially addressing the urgent need for new therapies amid rising addiction and suicide rates.

Current research indicates that psilocybin may offer therapeutic benefits without the overdose risks associated with traditional mind-altering substances, suggesting a safer option for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psilocybin Therapeutic Research: The Present and Future Paradigm. Kargbo, RB.[2021]

In a phase II study involving 19 adults with treatment-resistant depression, a single 25 mg dose of synthetic psilocybin (COMP360) showed a significant reduction in depression scores, with a mean change of -14.9 on the MADRS scale after 3 weeks.

The treatment was generally safe, with 63.2% of participants experiencing mild treatment-emergent adverse events, but no serious adverse events or increased suicidal thoughts were reported, indicating a favorable safety profile for psilocybin in this context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psilocybin for treatment resistant depression in patients taking a concomitant SSRI medication. Goodwin, GM., Croal, M., Feifel, D., et al.[2023]

In a feasibility trial involving 12 patients with treatment-resistant depression, psilocybin was found to be well tolerated, with no serious adverse events reported, although some patients experienced transient anxiety and confusion.

Patients showed significant reductions in depressive symptoms one week and three months after receiving high doses of psilocybin, indicating its potential efficacy as a treatment for unipolar depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psilocybin with psychological support for treatment-resistant depression: an open-label feasibility study. Carhart-Harris, RL., Bolstridge, M., Rucker, J., et al.[2022]

Psilocybin, a psychedelic drug, shows promising safety and efficacy in treating major depression and treatment-resistant depression (TRD), with initial phase 2 trials indicating positive outcomes when combined with psychological support.

The first international randomized controlled trial in 2022 found that a 25 mg dose of psilocybin was effective compared to an active placebo, and phase 3 trials are set to begin in 2023, suggesting a growing interest in psilocybin as a viable treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The development of psilocybin therapy for treatment-resistant depression: an update. Borissova, A., Rucker, JJ.[2023]

A proof-of-concept randomized controlled trial is being conducted with 60 adults suffering from treatment-resistant depression (TRD) to assess the feasibility and safety of combining psilocybin with risperidone, which is expected to block the psychedelic effects of psilocybin.

The study aims to provide pilot data on the antidepressant effects of this combination compared to psilocybin alone, potentially allowing for psilocybin to be used as a treatment for TRD without the need for a psychedelic experience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psilocybin for treatment-resistant depression without psychedelic effects: study protocol for a 4-week, double-blind, proof-of-concept randomised controlled trial. Husain, MI., Blumberger, DM., Castle, DJ., et al.[2023]

A single 25 mg dose of psilocybin has shown short-term antidepressant effects in individuals with medication-resistant depression, suggesting it may be a promising treatment option.

Further research is needed to understand the relationship between psilocybin's psychedelic effects and its antidepressant benefits, as well as to assess potential risks, including suicide risk associated with its use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is psilocybin an effective antidepressant and what is its Mechanism of action? Mann, JJ.[2023]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Efficacy and safety of psilocybin-assisted treatment for major depressive disorder: Prospective 12-month follow-up. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Single-dose psilocybin-assisted therapy in major depressive disorder: A placebo-controlled, double-blind, randomised clinical trial. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Assessing potential of psilocybin for depressive disorders. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Psilocybin-assisted therapy for major depressive disorder: An exploratory placebo-controlled, fixed-order trial. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Psilocybin Therapeutic Research: The Present and Future Paradigm. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Psilocybin for treatment resistant depression in patients taking a concomitant SSRI medication. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Psilocybin with psychological support for treatment-resistant depression: an open-label feasibility study. [2022]

8. England pubmed.ncbi.nlm.nih.gov

The development of psilocybin therapy for treatment-resistant depression: an update. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Psilocybin for treatment-resistant depression without psychedelic effects: study protocol for a 4-week, double-blind, proof-of-concept randomised controlled trial. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

Trial of Psilocybin versus Escitalopram for Depression. [2021]

11. United States pubmed.ncbi.nlm.nih.gov

Is psilocybin an effective antidepressant and what is its Mechanism of action? [2023]