90 Participants Needed

Psilocybin-Assisted Therapy for Depression

(PAT-BD-01 Trial)

Recruiting at 3 trial locations
NW
VN
Overseen ByVy Ngo, B.Sc
Stay on Your Current MedsYou can continue your current medications while participating
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

Will I have to stop taking my current medications?

You may need to stop taking certain medications at least 2 weeks before the dosing visit and throughout the study, but lamotrigine, valproate, lithium, and lorazepam (up to 2 mg/day) are allowed. The protocol does not specify all prohibited medications, so it's best to discuss your current medications with the study team.

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

Research suggests that psilocybin, when used with therapeutic support, can quickly and significantly reduce symptoms of depression, with effects lasting from just one or two doses. Studies have shown that psilocybin affects brain activity in ways that may help alleviate depression.12345

Is psilocybin-assisted therapy generally safe for humans?

Psilocybin-assisted therapy is generally considered safe when administered under supervision, with most side effects being mild and temporary. Serious adverse events are uncommon, but there have been reports of increased suicidal thoughts and behaviors in some cases, so further research is needed to understand who might be at risk.678910

How is the drug psilocybin different from other depression treatments?

Psilocybin is unique because it can produce rapid and lasting antidepressant effects with just one or two doses, unlike traditional antidepressants that often require daily use. It works by activating serotonin 2A receptors in the brain, which is different from how most standard depression medications function.1361112

What is the purpose of this trial?

This study is a 12-week (in addition to up to 30 days of screening) randomized, double-blind, placebo-controlled, parallel-group trial. The primary objective of this study is to assess the effectiveness, safety, and tolerability of single-dose psilocybin (25 mg)-assisted therapy in comparison to active placebo (1 mg micro-dose) psilocybin-assisted therapy in patients with bipolar II depression who have not responded to adequate trials with at least two first or second-line treatments for bipolar II depression (i.e. quetiapine, lithium, lamotrigine, sertraline, or venlafaxine as monotherapy or adjunctive therapy, or bupropion adjunctive therapy). The active placebo is a substance that looks identical to the study medication but contains less therapeutic ingredients, and thus is less capable of producing the transformative and meaningful aspects of psychedelic experience compared to the 25 mg dose. Participants will have a total of 11 study visits over a period of up to 16 weeks, which includes 5 therapy sessions from trained study therapists.

Research Team

DL

Dr. Lakshmi N Yatham

Principal Investigator

UBC Department of Psychiatry

Eligibility Criteria

This trial is for individuals with bipolar II depression who haven't improved after trying at least two different treatments, such as quetiapine, lithium, or sertraline. Participants should be stable and have no other psychological conditions that could interfere with the study.

Inclusion Criteria

Sufficient English language skills to understand and comply with study requirements
Willing to practice highly effective contraception methods or abstain from heterosexual intercourse
I have bipolar type II and am currently experiencing a major depressive episode.
See 3 more

Exclusion Criteria

History of rapid cycling (4 or more mood episodes in the preceding 12 months)
Lifetime history of a primary psychotic disorder
History of psychotic symptoms
See 11 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single dose of psilocybin (25 mg) or active placebo (1 mg) with therapy sessions

12 weeks
11 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Psilocybin
Trial Overview The study tests if a single high dose of psilocybin (25 mg) in therapy sessions helps more than a very low dose (1mg), which serves as an active placebo. The trial lasts up to 16 weeks and includes double-blind testing where neither doctors nor patients know who gets what treatment.
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: ActiveExperimental Treatment1 Intervention
25 mg psilocybin.
Group II: PlaceboPlacebo Group1 Intervention
1 mg psilocybin (micro-dose)

Find a Clinic Near You

Who Is Running the Clinical Trial?

Lakshmi N Yatham

Lead Sponsor

Trials
2
Recruited
100+

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.
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 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.
Psilocybin-assisted therapy for major depressive disorder: An exploratory placebo-controlled, fixed-order trial.Sloshower, J., Skosnik, PD., Safi-Aghdam, H., et al.[2023]
In a study using the Flinders Sensitive Line rat model of depression, neither psilocin nor psilocybin demonstrated an antidepressant-like effect, as measured by the forced swim test, which assesses immobility and swimming behavior.
Despite previous positive results in humans, this study suggests that the Flinders Sensitive Line model may not be suitable for testing the effects of psilocybin, indicating a need for alternative animal models or behavioral tests in future research.
Psilocybin lacks antidepressant-like effect in the Flinders Sensitive Line rat.Jefsen, O., Højgaard, K., Christiansen, SL., et al.[2020]

References

Efficacy and safety of psilocybin-assisted treatment for major depressive disorder: Prospective 12-month follow-up. [2022]
Psilocybin for the Treatment of Depression: A Promising New Pharmacotherapy Approach. [2023]
Psilocybin-assisted therapy for major depressive disorder: An exploratory placebo-controlled, fixed-order trial. [2023]
Psilocybin lacks antidepressant-like effect in the Flinders Sensitive Line rat. [2020]
Single-Dose Psilocybin Treatment for Major Depressive Disorder: A Randomized Clinical Trial. [2023]
Single-dose psilocybin-assisted therapy in major depressive disorder: A placebo-controlled, double-blind, randomised clinical trial. [2023]
Psilocybin history, action and reaction: A narrative clinical review. [2023]
Psilocybin for treatment resistant depression in patients taking a concomitant SSRI medication. [2023]
The development of psilocybin therapy for treatment-resistant depression: an update. [2023]
Pharmacokinetics of Escalating Doses of Oral Psilocybin in Healthy Adults. [2022]
Assessing potential of psilocybin for depressive disorders. [2023]
Psilocybin for treatment-resistant depression without psychedelic effects: study protocol for a 4-week, double-blind, proof-of-concept randomised controlled trial. [2023]
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