Generalized Anxiety Disorder (GAD)Phase 2NCT06969170
Safety, Tolerability, and Preliminary Efficacy of Psilocybin Oral Solution in Adults With Generalized Anxiety Disorder
A Phase 2 study testing Psilocybin (drug) in people with Generalized Anxiety Disorder (GAD), run by Claudio N Soares at 1 site in Canada.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Generalized Anxiety Disorder (GAD)
- What is being tested?
- Psilocybin (drug)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- 16 May 2025to 30 Dec 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Must provide written informed consent prior to the initiation of any protocol-specific procedures.
- 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:
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- 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).
- Agree to avoid pregnancy and use a medically acceptable method of contraception with male sexual partners from at least 30 days prior to the study until 30 days after the study has ended (last study procedure).
- Medically acceptable methods of contraception include any of the following:
- Double-barrier methods (e.g., male condom, spermicide with diaphragm or spermicide with cervical cap)
- Oral contraceptives; hormonal patch, implant or injection; or hormonal or non-hormonal intrauterine device. The male partner should use, at all times, a male condom with spermicide, should the female Patient choose to use any of these methods
- Complete abstinence, should it be in line with the Patient's preferred and usual lifestyle.
- Males who are able to father children must agree to use medically acceptable methods of contraception during the study and for 30 days after the last study drug administration. If a patient's partner should become pregnant during his participation in the study and for 30 days after he has completed his last study drug administration, the patient must inform study staff immediately. Medically acceptable methods of contraception include:
- Using a condom with a female partner of child-bearing potential who is using oral contraceptives; hormonal patch, implant or injection; hormonal or non-hormonal intrauterine device; or diaphragm or cervical cap with spermicide
- Complete abstinence, should it be in line with the patient's preferred and usual lifestyle.
- Males must refrain from sperm donation from clinic admission to at least 30 days after the last dose of study drug.
- Must be able to speak, read, and understand English sufficiently to allow completion of all study assessments.
- Must be willing to comply with the requirements and restrictions of the study.
Who cannot join
- 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).
- History or presence of any clinically significant cardiac, endocrine, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, renal, or other disease at Screening, which, in the opinion of the investigator, would jeopardize the safety of the patient or the validity of the study results.
- Recently initiated non-pharmacological treatment (e.g., Cognitive Behavioral Therapy, psychotherapy) with a psychologist or health care professional (i.e., <4 weeks prior to Screening). Patients who began a stable non-pharmacological treatment regimen >4 weeks prior to Screening will be permitted. Patients currently stable on treatment will not be permitted to modify or introduce new elements to their existing treatment regimen while enrolled in the study.
- Currently taking pharmacological treatment for GAD or depressive symptoms on a daily basis as outlined in Table 2. Patients who discontinue pharmacological treatment within a minimum of 4 weeks or more of baseline will be permitted to enroll in the study. Sporadic, prn use of anxiolytics will be permitted; however, patients will be required to document all medication use prior to study enrollment (See Section 9.7).
- 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.
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- 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).
- Has used CNS drugs with perception-altering properties (e.g., ketamine, lysergic acid diethylamide [LSD], phencyclidine [PCP], 3,4 methylenedioxymethamphetamine [MDMA], mescaline, psilocybin, tryptamine derivatives, or ring-substituted amphetamines with perception-altering effects) on more than 1 occasion for therapeutic or non-therapeutic purposes (i.e., for psychoactive effects) within the past 6 months. History of single or episodic use will not be considered exclusionary.
- History of suicidal ideation in the past 12 months or active/current suicidality, based on C-SSRS results.
- Is currently using an investigational drug or device or has used such in the 30 days prior to receiving study drug.
- Female patient is pregnant or breastfeeding.
- Patient, in the investigator's opinion, is unsuitable for clinical study participation.
- Criteria for Randomization into the Double-Blind Treatment Phase
- 1. Minimum 50% reduction in GAD-7 score from Open-Label Baseline Visit (Visit 1) to Double-Blind Baseline Visit
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Kingston General Health Research Institute
Kingston, Ontario, K7L 2V7
Claudio Soares, MD, PhD, FRCPC, MBA, 1-613-548-3232 ext. 4475, claudio.soares@kingstonhsc.ca
Yan Deng, MSc, RP, 1-613-548-3232, yan.deng@queensu.ca
About this study
Official title: 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
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)
Read more
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
- Generalized Anxiety Disorder (GAD)
- Being tested
- Psilocybin (drug), Placebo
- Keywords
- Psilocybin, Double-Blind, Psychedelic, Generalized Anxiety Disorder
- Medical subject headings
- Generalized Anxiety Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psilocybin (drug)Drug
Psilocybin 3mg Po (oral solution) administered daily for 28 days (Open-Label Run-in Phase) followed by Psilocybin 3mg Po (oral solution) OR Placebo for 28 days (Double-Blind Treatment Phase) in patients with Generalized Anxiety Disorder(GAD)
PlaceboOther
Sucralose 0.2% oral solution
| Study group | Role | What they receive |
|---|---|---|
| Psilocybin Oral Solution | Experimental | Psilocybin 3mg Po (oral solution) once daily Receives: Drug: Psilocybin (drug) |
| Placebo (Sucralose oral solution) | Placebo comparator | Sucralose PO (oral solution) once daily Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the safety and tolerability of psilocybin
Measured by:
- Incidence, relationship and severity of Adverse Events (AEs), Adverse Events of Special Interest (AESIs) and Serious Adverse Events(SAEs)
Measured: From Enrollment to the End of Treatment Phase at week 14
Secondary outcomes (1)
Changes in symptoms of anxiety from baseline
Measured by:
- Changes in Hamilton Anxiety Rating Scale (HAM-A) - with a total score range of 0-56, where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe
Measured: From Enrollment to the End of Treatment Phase at week 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2025
- Study start16 May 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Generalized Anxiety Disorder (GAD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Randomized, double-blind, placebo-controlled, clinical trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Claudio N Soares
- Sponsor type
- University, hospital or other
- Collaborators
- Diamond Therapeutics Inc., Kingston Health Sciences Centre
- Responsible party
- Sponsor-investigator, Claudio N Soares, Queen's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06969170
- Sponsor's protocol ID
- DTI-02a-001
- Other IDs
- HC6-024-c282159
- Status last verified
- Aug 2026
- First submitted
- 15 Apr 2025
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Double-blinded trial
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06969170
- Acronym / sponsor ID
- DTI-02a-001
- Conditions
- Generalized Anxiety Disorder (GAD)
- Keywords
- Psilocybin, Double-Blind, Psychedelic, Generalized Anxiety Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Claudio N SoaresUniversity, hospital or other
- Collaborators
- Diamond Therapeutics Inc., Kingston Health Sciences Centre
- Study start
- 16 May 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 13 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, double-blind, placebo-controlled, clinical trial
| Arm | Type | Receives |
|---|---|---|
| Psilocybin Oral Solution | Experimental | Drug: Psilocybin (drug)Psilocybin 3mg Po (oral solution) once daily |
| Placebo (Sucralose oral solution) | Placebo comparator | Other: PlaceboSucralose PO (oral solution) once daily |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (19 listed)
- Must provide written informed consent prior to the initiation of any protocol-specific procedures.
- 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).
Key exclusion criteria (18 listed)
- 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).
- History or presence of any clinically significant cardiac, endocrine, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, renal, or other disease at Screening, which, in the opinion of the investigator, would jeopardize the safety of the patient or the validity of the study results.
- Recently initiated non-pharmacological treatment (e.g., Cognitive Behavioral Therapy, psychotherapy) with a psychologist or health care professional (i.e., <4 weeks prior to Screening). Patients who began a stable non-pharmacological treatment regimen >4 weeks prior to Screening will be permitted. Patients currently stable on treatment will not be permitted to modify or introduce new elements to their existing treatment regimen while enrolled in the study.
- Currently taking pharmacological treatment for GAD or depressive symptoms on a daily basis as outlined in Table 2. Patients who discontinue pharmacological treatment within a minimum of 4 weeks or more of baseline will be permitted to enroll in the study. Sporadic, prn use of anxiolytics will be permitted; however, patients will be required to document all medication use prior to study enrollment (See Section 9.7).
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psilocybin (drug)Psilocybin 3mg Po (oral solution) administered daily for 28 days (Open-Label Run-in Phase) followed by Psilocybin 3mg Po (oral solution) OR Placebo for 28 days (Double-Blind Treatment Phase) in patients with Generalized Anxiety Disorder(GAD) | Drug | Psilocybin Oral Solution |
| PlaceboSucralose 0.2% oral solution | Other | Placebo (Sucralose oral solution) |
Primary outcome
To assess the safety and tolerability of psilocybin
Time frame: From Enrollment to the End of Treatment Phase at week 14
Measured by: - Incidence, relationship and severity of Adverse Events (AEs), Adverse Events of Special Interest (AESIs) and Serious Adverse Events(SAEs)
1 secondary outcome
Changes in symptoms of anxiety from baseline
Time frame: From Enrollment to the End of Treatment Phase at week 14
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- Individual participant dataSharing planned: No. Double-blinded trial
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Psilocybin (drug) in people with Generalized Anxiety Disorder (GAD), run by Claudio N Soares at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Claudio N Soares, MD, PhD, FRCPC, MBA (1-613-548-3232 ext. 4475, claudio.soares@kingstonhsc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the safety and tolerability of psilocybin (time frame: From Enrollment to the End of Treatment Phase at week 14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.