Psilocybin for Generalized Anxiety Disorder

Overseen By Claudio N Soares, MD, PhD, FRCPC, MBA

Age: 18 - 65

Sex: Any

Trial Phase: Phase 2

Sponsor: Queen's University

Must not be taking: Anxiolytics, Antidepressants, CNS drugs

Disqualifiers: Schizophrenia, Bipolar, Cardiac disease, others

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

Compensation: Varies

Number of Visits: 5

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the safety and effectiveness of a psilocybin oral solution, a compound found in certain mushrooms, for treating Generalized Anxiety Disorder (GAD). Participants will receive either the psilocybin solution or a placebo to assess its impact on anxiety symptoms. Individuals who have had GAD for at least one year and are not currently taking medication for anxiety might be suitable candidates for this trial. The trial seeks to determine if psilocybin could offer a new way to manage anxiety symptoms. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Do I have to stop taking my current medications to join the trial?

Yes, if you are currently taking medication for anxiety or depression daily, you must stop at least 4 weeks before the trial starts. However, occasional use of anxiety medication is allowed if documented before joining the study.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that psilocybin is generally well-tolerated. In studies involving various psychedelics, including psilocybin, most participants experienced only mild issues, such as brief increases in blood pressure or nausea. These side effects were temporary and not serious. One study found that a single dose of psilocybin was safe for healthy individuals, with no major physical or mental harm reported. This suggests that psilocybin could be safe for treating conditions like anxiety, though further research is needed to confirm this. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for Generalized Anxiety Disorder?

Unlike the standard treatments for generalized anxiety disorder, which typically involve SSRIs like sertraline or SNRIs such as venlafaxine, psilocybin offers a completely different approach. Psilocybin is a psychedelic compound that acts on serotonin receptors in the brain, potentially leading to rapid and profound changes in mood and perception. Researchers are excited about psilocybin because it might provide significant relief in just a single or few doses, rather than the daily dosing needed with traditional medications. Additionally, its potential to promote long-lasting effects after short-term use could revolutionize anxiety treatment by minimizing ongoing medication dependence and side effects.

What evidence suggests that psilocybin might be an effective treatment for Generalized Anxiety Disorder?

Research has shown that psilocybin, which participants in this trial may receive as an oral solution, may help treat anxiety. Studies have found that psilocybin can lower anxiety levels and lessen its negative effects. In one study, individuals with Generalized Anxiety Disorder (GAD) experienced an average drop of 7.4 points in their anxiety scores after taking psilocybin. This suggests that psilocybin might help people with anxiety feel better. Additionally, other studies have shown that most people can take psilocybin without serious side effects. These findings support the potential of psilocybin to treat anxiety disorders like GAD. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

Adults with Generalized Anxiety Disorder (GAD) who have a moderate level of anxiety as measured by the Hamilton Anxiety Rating Scale and are not currently on regular anxiety medication or have stopped such treatment at least 4 weeks prior to the trial. Participants must be able to attend weekly clinic visits and perform remote check-ins.

Inclusion Criteria

Must provide written informed consent prior to the initiation of any protocol-specific procedures

Meets DSM-V criteria for a primary diagnosis of GAD at Screening (duration of diagnosis ≥1 year, confirmed using the MINI)

Must be able to speak, read, and understand English sufficiently to allow completion of all study assessments

Exclusion Criteria

Personal history of schizophrenia, bipolar affective disorder, delusional disorder, paranoid disorder, moderate or severe panic disorder, moderate or severe social anxiety disorder, schizoaffective disorder, moderate or severe obsessive-compulsive disorder, anorexia nervosa, bulimia nervosa, moderate or severe post-traumatic stress disorder (as assessed by the IES-R), moderate or severe personality disorder (Cluster B and Cluster C only), moderate or severe MDD (as assessed by the MINI and total scores on the MADRS > 19)

I don't have any major health issues that could affect my safety in the study or its results.

I started or have been on a stable mental health therapy for over 4 weeks.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

up to 4 weeks

1 visit (in-person)

Open-label Run-in

Eligible patients attend weekly clinic visits and remote contacts for safety assessments, cognitive testing, EEG, and other patient-reported outcomes

4 weeks

4 visits (in-person), weekly remote contacts

Double-blind Treatment

Participants receive either psilocybin oral solution or placebo, with safety assessments, cognitive testing, EEG, and other patient-reported outcomes

4 weeks

Multiple visits (in-person)

End of Treatment

Further assessment of safety and patient-reported outcomes

2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Psilocybin Oral Solution

Trial Overview The trial is testing a psilocybin oral solution against a placebo over three phases: an initial screening, a 4-week open-label phase where all receive psilocybin, followed by a double-blind phase where responders to treatment are randomly given either psilocybin or placebo for another 4 weeks.

How Is the Trial Designed?

Group I: Psilocybin Oral Solution Experimental Treatment 1 Intervention

Psilocybin 3mg Po (oral solution) once daily

Group II: Placebo (Sucralose oral solution) Placebo Group 1 Intervention

Sucralose PO (oral solution) once daily

Who Is Running the Clinical Trial?

Queen's University

Lead Sponsor

Trials

382

Recruited

122,000+

Kingston Health Sciences Centre

Collaborator

Trials

32

Recruited

34,400+

Diamond Therapeutics Inc.

Industry Sponsor

Trials

1

Recruited

60+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06969170

Safety, Tolerability, and Preliminary Efficacy of Psilocybin ... Double-blind Treatment Phase Participants who demonstrate a treatment response during the Open-label Phase-defined as a ≥50% reduction in GAD-7 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10741816/

Efficacy and Safety of Psychedelics in Treating Anxiety ... The principal finding of our review is that ketamine, LSD, MDMA, and psilocybin decrease anxiety scores and/or the negative effects of anxiety and are well- ...

3. ir.incannex.com ir.incannex.com/news-releases/news-release-details/incannex-reports-positive-results-phase-2-clinical-trial-psx-001

Incannex Reports Positive Results from Phase 2 Clinical ... GAD-7 (Generalised Anxiety Disorder 7-item scale): The Psi-GAD group recorded an average 7.4-point reduction in GAD-7 scores, compared to a 3.5- ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0010440X25000471

Single-dose (10 mg) psilocybin reduces symptoms in ... A 10 mg dose of oral psilocybin was found to be well-tolerated and potentially efficacious in patients with OCD.

5. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2836921

Control Group Outcomes in Trials of Psilocybin, SSRIs, or ... This meta-analysis found that participants receiving control treatment in psilocybin trials had significantly less improvement in depression ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06969170?spons=COVERAGE%5BFullMatch%5DEXPANSION%5BNone%5D(%22Diamond%20Therapeutics%20Inc.%22)&viewType=Table&rank=2

Safety, Tolerability, and Preliminary Efficacy of Psilocybin ... This Phase 2a clinical trial is designed to evaluate the safety, tolerability, and preliminary efficacy of a 3 mg dose of psilocybin oral solution for the ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S277240852400125X

Safety pharmacology of acute psilocybin administration in ... These findings suggest that a single administration of psilocybin is safe with regard to acute psychological and physical harm in healthy participants in a ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6007659/

Clinical potential of psilocybin as a treatment for mental health ... Anxiety significantly decreased as measured by the State-Trait Anxiety Inventory at 1 and 3 months posttreatment in the psilocybin group compared to niacin.