RecruitingPhase 2interventionalRules rewrite

Phase 2: testing Psilocybin (drug) for Generalized Anxiety Disorder (GAD)

This Phase 2a clinical trial is designed to measure the safety, tolerability, and preliminary how well it works 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), neither you nor the study doctors know who gets the real treatment 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.

Official registry: https://clinicaltrials.gov/study/NCT06969170 · Claudio N Soares · enrollment listed as 50

What this phase means

Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Psilocybin (drug), or Placebo. The registry lists allocation as randomized. This Phase 2a clinical trial is designed to measure the safety, tolerability, and preliminary how well it works of a 3 mg dose of psilocybin oral solution for the treatment of Generalized Anxiety Disorder (GAD).

They plan to enroll about 50 people at Kingston. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

A Phase 2a, Placebo-Controlled Randomized, Double-Blind Trial to Evaluate the Safety, Tolerability, and Preliminary Efficacy of Psilocybin Oral Solution in Adults With Generalized Anxiety Disorder

Interventions: Psilocybin (drug), Placebo

Primary outcome (registry wording): To assess the safety and tolerability of psilocybin

Who it is for (from inclusion criteria)

Ages 18 Years to 60 Years
Male and female adults, between 18 and 60 years of age, inclusive
Meets DSM-V criteria for a primary diagnosis of GAD at Screening (duration of diagnosis ≥1 year, based on self-report), confirmed using the MINI
Clinician-rated GAD-7 score ≥14 at Screening (Visit 1)
Clinician-rated HAM-A score ≥14 at Screening (Visit1)
Females must be non-pregnant and non-lactating and must fulfil at least one of the following:
Be surgically sterile for a minimum of 6 months (achieved through hysterectomy, oophorectomy, or bilateral salpingectomy; note that tubal ligation is not considered a method of permanent sterilization)
Post-menopausal for a minimum of 1 year (confirmed by follicle-stimulating hormone test)

Who the registry excludes

Clinically significant abnormality on ECG, including a QT interval corrected for heart rate (Bazett; QTcB interval) of \>440 milliseconds in males and \>460 milliseconds in females
History of allergies to the investigational product or excipients
History of seizures, family history of seizures, history of head trauma, history of neurosurgery, or close family history of idiopathic generalized epilepsy or other congenital epilepsies
Positive for hepatitis B virus surface antigen, hepatitis C virus antibody, or human immunodeficiency virus (HIV) antibody
Positive urine drug screen at Screening , inclusive of cannabis use at a rate above 0.5g/day or 3g/week;
\- Abstinence commitment clause: Patients who use cannabis at below or up to the frequency/amount listed above may be allowed to participate if they are willing and able to discontinue use for the duration of the study period without experiencing withdrawal symptoms
Current or history of moderate or severe drug or alcohol use disorder (excluding caffeine and nicotine) within the past 2 years, or lifetime history of participation in a drug rehabilitation program (other than treatment for smoking cessation)

Public study contact (from the registry)

Claudio N Soares, MD, PhD, FRCPC, MBA

1-613-548-3232

claudio.soares@kingstonhsc.ca

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

1 listed

Kingston General Health Research Institute — Kingston, Ontario, Canada (recruiting)

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FAQ about this NCT record

Is NCT06969170 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT06969170?

Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT06969170?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary