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

Trial Summary

What is the purpose of this trial?

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 treatment of Generalized Anxiety Disorder (GAD). The study consists of three sequential phases: Screening Phase (up to 4 weeks), Open-label Run-in Phase (4 weeks), Double-blind Treatment Phase (4 weeks) Screening Phase During the Screening Visit, participants will provide informed consent and undergo a comprehensive medical evaluation, including an abbreviated psychiatric assessment, to determine eligibility. To qualify, patients must have a clinician-rated Hamilton Anxiety Rating Scale (HAM-A) score ≥14. Additionally, participants must not be on regular anxiolytic treatment or must have discontinued such treatment at least 4 weeks prior to the start of the Open-label Run-in Phase. Open-label Run-in Phase Eligible patients will proceed to the 4-week Open-label Run-in Phase. During this phase, patients will attend four weekly clinic visits, supplemented by weekly remote contacts (via phone or email). At different timepoints during the OL Run-in Phase, participants will complete safety assessments, undergo cognitive testing and EEG and other patient reported outcomes (PROs). Double-blind Treatment Phase Participants who demonstrate a treatment response during the Open-label Phase-defined as a ≥50% reduction in GAD-7 score from baseline-will be randomized 1:1 to receive either psilocybin oral solution or placebo at the Double-blind Baseline Visit. Patients not meeting the response criteria will undergo End-of-Treatment (ET) procedures at this visit. At different timepoints during the DB Treatment Phase, participants will complete safety assessments, undergo cognitive testing and EEG and other patient reported outcomes (PROs). Completion of the End of Treatment (ET) phase will be 2 weeks to further assess safety and PROs.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+