Major Depressive DisorderPhase 2PSI-1V2NCT06341426
Psilocybin-Assisted Psychotherapy for Treatment-Resistant Depression: Comparing One Versus Two Doses of Psilocybin
A Phase 2 study testing Single Psychedelic Dose Psilocybin and Two Psychedelic Doses Psilocybin in people with Major Depressive Disorder and Depression, run by University Health Network, Toronto at 2 sites in Canada.
Trial summary
The purpose of this study is to see if one or two doses of psilocybin is more effective in relieving depressive symptoms in patients with treatment-resistant depression (TRD). Researchers also want to know if a second dose of psilocybin is safe and well-tolerated. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depressive Disorder, Depression, Treatment-Resistant Depression
- What is being tested?
- Single Psychedelic Dose Psilocybin and Two Psychedelic Doses Psilocybin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 92 participants
- Where
- 2 sitesCanada
- Study dates
- 5 Feb 2024to 28 Dec 2026
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults 18 to 65 years old.
- Must be deemed to have capacity to provide informed consent.
- Must sign and date the informed consent form.
- Stated willingness to comply with all study procedures.
- Ability to read and communicate in English, such that their literacy and comprehension is sufficient for understanding the consent form and study questionnaires, as evaluated by study staff obtaining consent.
- Meets DSM-5 criteria for MDD, currently experiencing a Major Depressive Episode (MDE) without psychotic features, as diagnosed by a mood disorder specialist. Diagnosis will be confirmed using the Mini-International Neuropsychiatric Interview (MINI).
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- Current MDE must be moderate to severe, as determined by a MADRS score greater than 21.
- Have not responded to at least two trials of antidepressants at an adequate dosage and duration based on the Antidepressant Treatment History Form Short Form (ATHF-SF) with no upper limit on the number of treatment failures.
- Ability to take oral medication.
- Individuals who are capable of becoming pregnant: use of highly effective contraception for at least 1 months prior to screening and agreement to use such a method during study participation in addition to monthly check-ins by study staff to determine the first day of their last menstrual period;
- Individuals who are capable of making their partner pregnant: use of condoms or other methods for the duration of study participation to ensure effective contraception with partner.
- Individuals who are willing to taper off concomitant medications (antidepressants, antipsychotics, mood stabilizers, ketamine, esketamine, monoaminergic medicines, and stimulants) for a minimum of 1-month prior to Baseline (V2, Day 0) and whose physician confirms that it is safe for them to do so.
- Individuals who are willing to not receive additional psychotherapy (outside of the therapy provided as part of the study) during the 8-week trial and whose physician confirms that it is safe for them to do so; however, they may continue seeing their therapist before and after this time period.
- Individuals who have a caregiver that will be able to bring them home after treatment sessions and stay with them for a minimum of 24 hours after discharge;
- Agreement to adhere to Lifestyle Considerations (section 4.5) throughout study duration.
Who cannot join
- Lifetime history of mania, hypomania or psychosis as determined by clinical psychiatric assessment and the MINI.
- Current symptoms of mania, hypomania or mixed features, as determined by the Young Mania Rating Scale (YMRS) score greater than 12.
- Substance, cannabis, or alcohol use disorder within the past 3 months or lifetime history of hallucinogen use disorder as determined by the MINI and urine drug screen.
- Major neurocognitive disorder, as determined by clinical assessment, including administration of the Montreal Cognitive Assessment (MoCA).
- Have active suicidal ideation as determined by the C-SSRS and/or clinical interview (significant suicide risk is defined by suicidal ideation as endorsed by items 4 or 5 of the C-SSRS) or active suicidality requiring involuntary inpatient treatment or recent suicide attempts within the past 3 months.
- Presence of a relative or absolute contraindication to psilocybin (within the past 12 months),, including a drug allergy, recent stroke history, uncontrolled hypertension, low or labile blood pressure, recent myocardial infarction (within the past 12 months),, cardiac arrhythmic, severe coronary artery disease, or moderate to severe renal (Glomerular Filtration Rate (GFR) less than 45ml/min/1.73 m2) or hepatic impairment (Child-Pugh B: 7 to 9 points and Child-Pugh C: 10 to 15 points).
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- Pregnant as assessed by a urine pregnancy test at Screening (V1) or individual's that intend to become pregnant during the study or are breastfeeding.
- Treatment with another investigational drug or other intervention within 30 days of Baseline (V2).
- Participants who will receive any form of brain stimulation (e.g., rTMS, ECT) during the trial or have within 30 days before Baseline (V2).
- Individuals who have had changes to psychiatric medications 30 days before entering the trial, outside of as needed (PRN) medications.
- Any DSM-5 lifetime diagnosis of a schizophrenia-spectrum disorder; obsessive- compulsive disorder, psychotic disorder (unless substance induced or due to a medical condition), bipolar I or II disorder, paranoid personality disorder, or borderline personality disorder as determined by medical history, the M.I.N.I clinical interview, and the International Personality Disorder Examination (IPDE) administered at Screening (V1).
- Any first-degree relative with a diagnosis of schizophrenia-spectrum disorder; psychotic disorder (unless substance-induced or due to a medical condition); or bipolar I or II disorder as determined by the family medical history form and discussions with the participant.
- Uncontrolled seizure disorder or a seizure within the past 12 months
- Presence of baseline prolonged QTc or Torsade de Pointes as measured by the ECG or a history of long QTc syndrome or related risk factors.
- Use of classic psychedelic drugs within the previous 6 months, including but not limited to psilocybin, psilocin, DMT, LSD, ayahuasca, mescaline, peyote, 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT).
- Any other clinically significant physical illness including chronic infectious diseases or any other major concurrent illness that, in the opinion of the investigator, may interfere with the interpretation of the study results or constitute a health risk for the participant if they take part in the study.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Toronto Western Hospital
Toronto, Ontario, M5T 2S8
Centre for Addiction and Mental Health (CAMH)
Toronto, Ontario, M6J 1H4
About this study
Official title: Psilocybin-Assisted Psychotherapy for Treatment-Resistant Depression: A Randomized Phase II Clinical Trial Comparing One Versus Two Psychedelic Doses of Psilocybin (PSI-1V2)
The purpose of this study is to see if one or two doses of psilocybin is more effective in relieving depressive symptoms in patients with treatment-resistant depression (TRD). Researchers also want to know if a second dose of psilocybin is safe and well-tolerated. This study will see if psilocybin is effective, safe, and well-tolerated by tracking changes in depressive symptoms, suicidality, and side effects. This study will also see if a second dose of psilocybin has an effect on quality of life, functioning, cognition (thinking, reasoning, remembering), and how long depressive symptoms improve (or worsen) after psilocybin is administered.
Read the detailed description
During the past decade, there has been increased interest in the use of psilocybin as a novel treatment for mental health disorders, including treatment-resistant depression (TRD). Recent studies have suggested that psilocybin has the potential to relieve depressive symptoms when combined with psychotherapy (i.e., psilocybin-assisted psychotherapy [PAP]). Each psilocybin dosing session requires the use of extensive resources, including two specialized therapists supporting the patient for 6-8 hours per dosing session. If two doses of psilocybin prove to be more effective than a single dose of psilocybin in relieving depressive symptoms, then two doses should be the standard intervention for future trials and clinical application. However, if a second dose of psilocybin does not offer increased anti-depressant benefit from the first dose, then a second dose of psilocybin would only increase the risk of adverse side effects and cost of treatment. Therefore, the purpose of this study is to determine whether a second dose of psilocybin provides better efficacy, safety and tolerability than a single dose. The investigators hypothesize that two doses of psilocybin will be more beneficial compared to a single dose, and that there will be no significant difference between the groups (one dose versus two doses) in safety or tolerability.
The primary objective of assessing antidepressant efficacy will be evaluated by the change in the Montgomery-Åsberg Depression Rating Scale (MADRS) between baseline and Week 8. Safety and tolerability will be assessed using standardized adverse effects monitoring, in addition to close participant monitoring during the dosing day (e.g., blood pressure changes, dissociative and psychotomimetic effects, treatment-emergent manic symptoms, and suicidality). Secondary objectives include evaluating the effects of one versus two psilocybin doses on suicidality, quality of life, functioning, cognition, and duration of clinical benefits during the six month observational follow-up period. Exploratory objectives include evaluating predictors of response, such as static and dynamic clinical factors and expectancy effects, and cost-effectiveness of one versus two psilocybin doses.
- Being tested
- Single Psychedelic Dose Psilocybin, Two Psychedelic Doses Psilocybin
- Keywords
- Depression, Major Depressive Disorder, Treatment-Resistant Depression, Mood Disorders, Psilocybin, Psychedelics, Psychotherapy, Psilocin, Mental Disorders, Hallucinogen, Antidepressant, Phase 2, Phase II
- Medical subject headings
- Depressive Disorder, Major, Depression, Depressive Disorder, Treatment-Resistant, Mood Disorders, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single Psychedelic Dose PsilocybinDrug
One psychedelic dose (1mg of psilocybin + 25mg of psilocybin) taken in conjunction with psilocybin-assisted psychotherapy
Two Psychedelic Doses PsilocybinDrug
Two psychedelic doses (25 mg of psilocybin + 25mg of psilocybin) taken in conjunction with psilocybin-assisted psychotherapy
| Study group | Role | What they receive |
|---|---|---|
| Two Doses of Psilocybin | Active comparator | Two psychedelic doses (25mg of psilocybin + 25mg of psilocybin) taken in conjunction with psilocybin-assisted psychotherapy Receives: Drug: Two Psychedelic Doses Psilocybin |
| Single Dose of Psilocybin | Placebo comparator | One psychedelic dose (1mg of psilocybin + 25mg of psilocybin) taken in conjunction with psilocybin-assisted psychotherapy Receives: Drug: Single Psychedelic Dose Psilocybin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antidepressant Efficacy
Antidepressant efficacy will be evaluated using change in Montgomery-Åsberg Depression Rating Scale (MADRS) score, a clinician-administered depression severity rating scale where higher scores indicate greater severity of depression symptoms. The MADRS has been validated extensively in major depressive disorder (MDD) and treatment-resistant depression (TRD) patient population samples, and specifically in psilocybin trials.
Measured: Baseline to Week 8 (Primary Endpoint)
Secondary outcomes (12)
Self-Reported Depression Symptoms
Self-assessment of depression symptoms using the Generalized Anxiety Disorder 7-Item where higher scores indicate greater severity.
Measured: Baseline to 6 month follow-up
Anxiety Symptoms
Self-assessment of anxiety symptoms using the 16-Item Quick Inventory for Depression Symptomatology where higher scores indicate greater severity.
Measured: Baseline to 6 month follow-up
Self-Reported Quality of Life
Self-assessment of quality of life measured by the World Health Organization-5, Well-Being Index where higher scores indicate a better quality of life score.
Measured: Baseline to 6 month follow-up
Subjective Functioning
Self-assessment of subjective function as measured by the Sheehan Disability Scale where higher scores indicate greater severity of disability symptoms.
Measured: Baseline to 6 month follow-up
Incidence of Treatment Emergent Adverse Events (Safety and Tolerability)
The incidence of adverse events will be measured throughout the trial. During dosing sessions, post-dose blood pressure changes will be recorded, as well as dissociative and psychotomimetic effects using the Clinician Administered Dissociative Symptom Scale (CADSS), the Brief Psychiatric Rating Scale-Positive Symptom Subscale (BPRS-PS), the Five-Dimensional Altered States of Consciousness (5D-ASC), the Ego-Dissolution Inventory (EDI) and the Mystical Experience Questionnaire (MEQ). Higher scores on these aforementioned scales indicate greater dissociation/altered perception as a measure of adverse psychological symptoms.
Measured: Baseline to 6 month follow-up
Cognitive Dysfunction
The Perceived Deficits Questionnaire-5 Item is a brief patient-rated scale that assesses cognitive dysfunction in people with depression. It is a 5-item questionnaire that is a subset of the larger 20-item questionnaires. Participants rank each item on frequency in the last week using a scale ranging from "never" to "always".
Measured: Baseline to 6 month follow-up
Psychomotor Performance
The Digit Symbol Substitution Test is a pencil and paper test of psychomotor performance. Participants will be key grid of numbers and matching symbols and are asked to fill as many empty boxes as possible with the symbol matching each number. The score is the number of correct number-symbol matches achieved in 90 seconds.
Measured: Baseline to 6 month follow-up
Phonemic Word Fluency
The FAS Verbal Fluency Test is a measure of phonemic word fluency. The number of words recited that begin with the letters 'F', 'A', and 'S' within a one-minute time frame serves as a measure of word fluency.
Measured: Baseline to 6 month follow-up
Psychomotor Speed, Visual search, and Attention
The Trail Making Tests A and B require participants to connect numbered circles with a pencil as quickly as possible in a numerical or alternating alphanumeric sequence respectively. Shorter time to complete these tests and fewer errors denotes higher performance.
Measured: Baseline to 6 month follow-up
Verbal Learning and Memory
The California Verbal Learning test is a comprehensive, detailed assessment of verbal learning and memory deficits. The Standard and Alternate Forms include tests of immediate and delayed recall, and recognition. The number of words recalled or recognized accurately in each test denotes better performance and is compared using a standardized score across participants.
Measured: Baseline to 6 month follow-up
Working Memory, Attention and Executive Function
The Symbol Check game from THINC-it is inspired by the one-back task and the Spotter game from THINC-it is inspired by the Choice Reaction Time task. These measures are performed consecutively and are scored based on speed and accuracy.
Measured: Baseline to 6 month follow-up
Effort-Based Decision Making
The Effort Expenditure for Reward Task is a behavioral paradigm that measures effort-based decision-making. Participants are presented with a series of repeated trials in which they are able to choose between performing a "hard-task" or an "easy-task" in order to earn varying amounts of monetary reward. The test is scored based on what task the participant selects and performance on each task.
Measured: Baseline to 6 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2024
- Study start5 Feb 2024
- Primary completion28 Jul 2026 (estimated)
- Study completion28 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized to two groups for the first dosing session in a 1:1 allocation: 1) non-psychedelic/placebo dose (psilocybin 1mg) or 2) psychedelic dose (psilocybin 25mg). All participants will receive a psychedelic dose (psilocybin 25mg) for their second dosing session.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 92 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Centre for Addiction and Mental Health
- Responsible party
- Principal investigator, Joshua Rosenblat, University Health Network, Toronto
- Investigators
- Joshua Rosenblat, MD, MSc, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06341426
- Sponsor's protocol ID
- 23-5872
- Acronym
- PSI-1V2
- Status last verified
- Jul 2026
- First submitted
- 4 Mar 2024
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psilocybin-Assisted Psychotherapy for Treatment-Resistant Depression: A Randomized Phase II Clinical Trial Comparing One Versus Two Psychedelic Doses of Psilocybin (PSI-1V2)
- ClinicalTrials.gov ID
- NCT06341426
- Acronym / sponsor ID
- PSI-1V2 / 23-5872
- Keywords
- Depression, Major Depressive Disorder, Treatment-Resistant Depression, Mood Disorders, Psilocybin, Psychedelics, Psychotherapy, Psilocin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Centre for Addiction and Mental Health
- Study start
- 5 Feb 2024 (actual)
- Primary completion
- 28 Jul 2026 (estimated)
- Study completion
- 28 Dec 2026 (estimated)
- First posted
- 2 Apr 2024 (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.
The purpose of this study is to see if one or two doses of psilocybin is more effective in relieving depressive symptoms in patients with treatment-resistant depression (TRD). Researchers also want to know if a second dose of psilocybin is safe and well-tolerated. This study will see if psilocybin is effective, safe, and well-tolerated by tracking changes in depressive symptoms, suicidality, and side effects. This study will also see if a second dose of psilocybin has an effect on quality of life, functioning, cognition (thinking, reasoning, remembering), and how long depressive symptoms improve (or worsen) after psilocybin is administered.
Detailed description
During the past decade, there has been increased interest in the use of psilocybin as a novel treatment for mental health disorders, including treatment-resistant depression (TRD). Recent studies have suggested that psilocybin has the potential to relieve depressive symptoms when combined with psychotherapy (i.e., psilocybin-assisted psychotherapy [PAP]). Each psilocybin dosing session requires the use of extensive resources, including two specialized therapists supporting the patient for 6-8 hours per dosing session. If two doses of psilocybin prove to be more effective than a single dose of psilocybin in relieving depressive symptoms, then two doses should be the standard intervention for future trials and clinical application. However, if a second dose of psilocybin does not offer increased anti-depressant benefit from the first dose, then a second dose of psilocybin would only increase the risk of adverse side effects and cost of treatment. Therefore, the purpose of this study is to determine whether a second dose of psilocybin provides better efficacy, safety and tolerability than a single dose. The investigators hypothesize that two doses of psilocybin will be more beneficial compared to a single dose, and that there will be no significant difference between the groups (one dose versus two doses) in safety or tolerability.
The primary objective of assessing antidepressant efficacy will be evaluated by the change in the Montgomery-Åsberg Depression Rating Scale (MADRS) between baseline and Week 8. Safety and tolerability will be assessed using standardized adverse effects monitoring, in addition to close participant monitoring during the dosing day (e.g., blood pressure changes, dissociative and psychotomimetic effects, treatment-emergent manic symptoms, and suicidality). Secondary objectives include evaluating the effects of one versus two psilocybin doses on suicidality, quality of life, functioning, cognition, and duration of clinical benefits during the six month observational follow-up period. Exploratory objectives include evaluating predictors of response, such as static and dynamic clinical factors and expectancy effects, and cost-effectiveness of one versus two psilocybin doses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized to two groups for the first dosing session in a 1:1 allocation: 1) non-psychedelic/placebo dose (psilocybin 1mg) or 2) psychedelic dose (psilocybin 25mg). All participants will receive a psychedelic dose (psilocybin 25mg) for their second dosing session.
| Arm | Type | Receives |
|---|---|---|
| Two Doses of Psilocybin | Active comparator | Drug: Two Psychedelic Doses PsilocybinTwo psychedelic doses (25mg of psilocybin + 25mg of psilocybin) taken in conjunction with psilocybin-assisted psychotherapy |
| Single Dose of Psilocybin | Placebo comparator | Drug: Single Psychedelic Dose PsilocybinOne psychedelic dose (1mg of psilocybin + 25mg of psilocybin) taken in conjunction with psilocybin-assisted psychotherapy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Adults 18 to 65 years old.
- Must be deemed to have capacity to provide informed consent.
- Must sign and date the informed consent form.
- Stated willingness to comply with all study procedures.
- Ability to read and communicate in English, such that their literacy and comprehension is sufficient for understanding the consent form and study questionnaires, as evaluated by study staff obtaining consent.
Key exclusion criteria (16 listed)
- Lifetime history of mania, hypomania or psychosis as determined by clinical psychiatric assessment and the MINI.
- Current symptoms of mania, hypomania or mixed features, as determined by the Young Mania Rating Scale (YMRS) score greater than 12.
- Substance, cannabis, or alcohol use disorder within the past 3 months or lifetime history of hallucinogen use disorder as determined by the MINI and urine drug screen.
- Major neurocognitive disorder, as determined by clinical assessment, including administration of the Montreal Cognitive Assessment (MoCA).
- Have active suicidal ideation as determined by the C-SSRS and/or clinical interview (significant suicide risk is defined by suicidal ideation as endorsed by items 4 or 5 of the C-SSRS) or active suicidality requiring involuntary inpatient treatment or recent suicide attempts within the past 3 months.
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 |
|---|---|---|
| Single Psychedelic Dose PsilocybinOne psychedelic dose (1mg of psilocybin + 25mg of psilocybin) taken in conjunction with psilocybin-assisted psychotherapy | Drug | Single Dose of Psilocybin |
| Two Psychedelic Doses PsilocybinTwo psychedelic doses (25 mg of psilocybin + 25mg of psilocybin) taken in conjunction with psilocybin-assisted psychotherapy | Drug | Two Doses of Psilocybin |
Primary outcome
Antidepressant Efficacy
Time frame: Baseline to Week 8 (Primary Endpoint)
Antidepressant efficacy will be evaluated using change in Montgomery-Åsberg Depression Rating Scale (MADRS) score, a clinician-administered depression severity rating scale where higher scores indicate greater severity of depression symptoms. The MADRS has been validated extensively in major depressive disorder (MDD) and treatment-resistant depression (TRD) patient population samples, and specifically in psilocybin trials.
12 secondary outcomes
Self-Reported Depression Symptoms
Time frame: Baseline to 6 month follow-up
Anxiety Symptoms
Time frame: Baseline to 6 month follow-up
Self-Reported Quality of Life
Time frame: Baseline to 6 month follow-up
Subjective Functioning
Time frame: Baseline to 6 month follow-up
Incidence of Treatment Emergent Adverse Events (Safety and Tolerability)
Time frame: Baseline to 6 month follow-up
Cognitive Dysfunction
Time frame: Baseline to 6 month follow-up
Psychomotor Performance
Time frame: Baseline to 6 month follow-up
Phonemic Word Fluency
Time frame: Baseline to 6 month follow-up
Psychomotor Speed, Visual search, and Attention
Time frame: Baseline to 6 month follow-up
Verbal Learning and Memory
Time frame: Baseline to 6 month follow-up
Working Memory, Attention and Executive Function
Time frame: Baseline to 6 month follow-up
Effort-Based Decision Making
Time frame: Baseline to 6 month follow-up
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 9 Jul 2026.
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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. This study is not recruiting at the moment.
Joshua Rosenblat, MD, MSc principal investigator
University Health Network, Toronto
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Single Psychedelic Dose Psilocybin and Two Psychedelic Doses Psilocybin in people with Major Depressive Disorder and Depression, run by University Health Network, Toronto at 2 sites 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 15 inclusion and 16 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: under way, not looking for participants, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Antidepressant Efficacy (time frame: Baseline to Week 8 (Primary Endpoint)). 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 9 Jul 2026.