Actively Recruiting
Safety, Tolerability, and Preliminary Efficacy of Psilocybin Oral Solution in Adults With Generalized Anxiety Disorder
Led by Queen's University · Updated on 2025-05-13
50
Participants Needed
1
Research Sites
68 weeks
Total Duration
On this page
Sponsors
Q
Queen's University
Lead Sponsor
D
Diamond Therapeutics Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Safety, Tolerability, and Preliminary Efficacy of Psilocybin Oral Solution in Adults With Generalized Anxiety Disorder
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Must provide written informed consent before starting the study procedures
- Adults aged 18 to 60 years, male or female
- Diagnosed with Generalized Anxiety Disorder (GAD) for at least 1 year confirmed by clinical interview
- Clinician-rated GAD-7 score of 14 or higher at screening
- Clinician-rated Hamilton Anxiety Rating Scale (HAM-A) score of 14 or higher at screening
- Females must be non-pregnant and non-lactating and meet one of the following: surgically sterile for 6+ months, post-menopausal for 1+ year, or agree to use medically acceptable contraception from 30 days before until 30 days after the study
- Males able to father children must agree to use medically acceptable contraception during the study and for 30 days after last dose
- Males must avoid sperm donation from enrollment until 30 days after last dose
- Able to speak, read, and understand English to complete study assessments
- Willing to follow all study requirements and restrictions
You will not qualify if you...
- History of schizophrenia, bipolar 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 PTSD, moderate or severe personality disorder (Cluster B and C), or moderate or severe major depressive disorder
- Significant cardiac, endocrine, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, renal, or other disease that risks safety or study validity
- Started new non-drug therapy for anxiety less than 4 weeks before screening
- Currently taking daily medication for anxiety or depression (must have stopped at least 4 weeks before study)
- Abnormal ECG including QTcB interval >440 ms in males or >460 ms in females
- Allergies to study drug or ingredients
- History or family history of seizures or epilepsy
- Positive for hepatitis B, hepatitis C, or HIV
- Positive drug screen at screening including cannabis use above specified limits unless willing to abstain during study
- Moderate or severe drug or alcohol use disorder within past 2 years or history of drug rehab (except smoking cessation)
- Used perception-altering CNS drugs more than once in past 6 months
- Suicidal ideation in past 12 months or current suicidality
- Currently using or used investigational drug/device in past 30 days
- Pregnant or breastfeeding females
- Considered unsuitable for study by investigator
- Does not achieve minimum 50% reduction in GAD-7 score during Open-label Run-in Phase for randomization to double-blind treatment
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Kingston General Health Research Institute
Kingston, Ontario, Canada, K7L 2V7
Actively Recruiting
Research Team
C
Claudio N Soares, MD, PhD, FRCPC, MBA
CONTACT
E
Eric Dodd, MSc, BScN, RN, CCRP
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
2
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