Psilocybin Therapy for Depression in Bipolar II Disorder

(BAP Trial)

Overseen By Joshua D Woolley, MD,PhD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of California, San Francisco

Must not be taking: Antidepressants, Antipsychotics, Opioids, others

Disqualifiers: Bipolar I, Schizophrenia, Cancer, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 6

Duration: 6 weeks

14 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

You may need to stop taking certain medications that could interact with psilocybin, such as some antidepressants, antipsychotics, stimulants, opioids, and Lithium. Bupropion is allowed, but it's best to discuss your specific medications with the study team.

What data supports the effectiveness of the drug Psilocybin Therapy?

Research shows that psilocybin, a component of 'magic mushrooms', may help treat major depressive disorder and addiction, with studies indicating rapid antidepressant effects and potential for aiding smoking cessation. ^{1 2 3 4 5}

Is psilocybin therapy generally safe for humans?

Research suggests that psilocybin therapy is generally safe for humans when administered in a controlled, supportive environment. While some people may experience temporary anxiety or panic, these effects are usually manageable with support. Long-term negative effects are rare, and most participants report positive experiences. ^{4 6 7 8 9}

How is Psilocybin Therapy different from other treatments for this condition?

Psilocybin Therapy is unique because it involves the use of a psychedelic compound that can alter perception and mood, potentially offering a novel approach to mental health conditions. Unlike traditional medications, psilocybin is typically administered in a controlled therapeutic setting, which may enhance its effectiveness and safety. ^{10 11 12 13 14}

What is the purpose of this trial?

This trial is testing the safety and feasibility of using psilocybin, a substance from 'magic mushrooms,' to help people with Bipolar II Disorder who are currently depressed. Researchers want to see if this treatment can safely improve mood and quality of life for these patients. Psilocybin has shown promise as a treatment for depression and has been designated as a breakthrough therapy by the FDA.

Research Team

Joshua D Woolley, MD,PhD

Principal Investigator

University of California, San Francisco

David Guard, PhD

Principal Investigator

San Francisco State University

Eligibility Criteria

Inclusion Criteria

Age 30 to 65

Comfortable speaking and writing in English

Able to attend all in-person visits at UCSF as well as virtual visits

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preparatory Sessions

Participants engage in preparatory visits with trained facilitators before psilocybin administration

1-2 weeks

2-3 visits (in-person)

Treatment

Participants receive one or two doses of psilocybin in a monitored setting, with preparation and integration sessions

6 weeks

4-6 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

Monthly visits (in-person or virtual)

Treatment Details

Interventions

• Psilocybin Therapy

Participant Groups

Group I: Psilocybin therapy Experimental Treatment 1 Intervention

Participants will receive one or two doses of psilocybin in a monitored setting approximately three weeks apart, with preparation sessions before and integration sessions after.

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

Findings from Research

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]

In a pilot study involving 15 participants, those who underwent psilocybin-facilitated smoking cessation reported significant insights into their self-identity and reasons for smoking, which contributed to their ability to quit smoking.

Participants experienced lasting positive changes beyond smoking cessation, such as increased altruism and pro-social behavior, suggesting that the therapeutic effects of psilocybin may extend beyond the immediate treatment context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychedelic therapy for smoking cessation: Qualitative analysis of participant accounts. Noorani, T., Garcia-Romeu, A., Swift, TC., et al.[2019]

In a phase 2 trial with 104 participants, a single dose of psilocybin significantly reduced depression scores compared to a niacin placebo, showing a mean difference of -12.3 points on the MADRS scale by day 43, indicating strong efficacy.

Psilocybin treatment led to a significant reduction in functional disability as measured by the Sheehan Disability Scale, with no serious adverse events reported, suggesting it is a safe option when combined with psychological support for treating major depressive disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Single-Dose Psilocybin Treatment for Major Depressive Disorder: A Randomized Clinical Trial. Raison, CL., Sanacora, G., Woolley, J., et al.[2023]

The HOPE trial, involving 12 cancer patients, showed that psilocybin-assisted group therapy is safe, with no serious adverse events reported, and resulted in significant reductions in depression symptoms over six months.

Participants experienced substantial decreases in depression scores, with six out of twelve achieving remission at two weeks, indicating that this group therapy model could be an effective treatment for depression in cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

HOPE: A Pilot Study of Psilocybin Enhanced Group Psychotherapy in Patients With Cancer. Lewis, BR., Garland, EL., Byrne, K., 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 survey of 1993 individuals who experienced challenging psilocybin trips, 39% rated their experience as one of the most difficult of their lives, with 11% reporting risks of physical harm, particularly influenced by dose and lack of support.

Despite the challenges, 84% of respondents felt they benefited from the experience, suggesting that while adverse effects can occur, the overall incidence of serious psychological distress is low, especially in controlled settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Survey study of challenging experiences after ingesting psilocybin mushrooms: Acute and enduring positive and negative consequences. Carbonaro, TM., Bradstreet, MP., Barrett, FS., et al.[2018]

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]

References

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

Psychedelic therapy for smoking cessation: Qualitative analysis of participant accounts. [2019]

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

Single-Dose Psilocybin Treatment for Major Depressive Disorder: A Randomized Clinical Trial. [2023]

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

HOPE: A Pilot Study of Psilocybin Enhanced Group Psychotherapy in Patients With Cancer. [2023]

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

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

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

Survey study of challenging experiences after ingesting psilocybin mushrooms: Acute and enduring positive and negative consequences. [2018]

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

Acute, subacute and long-term subjective effects of psilocybin in healthy humans: a pooled analysis of experimental studies. [2016]

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

Study protocol of an open-label proof-of-concept trial examining the safety and clinical efficacy of psilocybin-assisted therapy for veterans with PTSD. [2023]

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

Tetrahydrocannabinol for tremor in multiple sclerosis. [2013]

11. England pubmed.ncbi.nlm.nih.gov

Efficacy and safety of dexanabinol in severe traumatic brain injury: results of a phase III randomised, placebo-controlled, clinical trial. [2016]

12. England pubmed.ncbi.nlm.nih.gov

A preliminary controlled study to determine whether whole-plant cannabis extracts can improve intractable neurogenic symptoms. [2017]

13. Australia pubmed.ncbi.nlm.nih.gov

Cannabis: are there any benefits? [2021]

14. England pubmed.ncbi.nlm.nih.gov

The California program for the investigational use of THC and marihuana in heterogeneous populations experiencing nausea and vomiting from anticancer therapy. [2019]