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Treatment-Resistant DepressionPhase 2PSI-TNTNCT07211438

Evaluating the Role of Psilocybin Monitors in Psilocybin Therapy for Treatment Resistant Depression

A Phase 2 study testing Psilocybin in people with Treatment-Resistant Depression, run by Centre for Addiction and Mental Health at 2 sites in Canada.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

Psilocybin, the chemical component of "magic mushrooms", has been administered with psychological support in several randomized clinical trials (RCTs) showing large and sustained antidepressant effects. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Treatment-Resistant Depression
What is being tested?
Psilocybin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
2 sitesCanada
Study dates
3 Jul 2026to Jan 2029
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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adults 18 to 70 years old;
  • Are outpatients;
  • Must be deemed to have capacity to provide informed consent;
  • Must read, sign and date the informed consent form independently. Proxy consent, including consent from a Legally Authorized Representative (LAR), is not permitted in this study;
  • 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
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  • Primary DSM-5 diagnosis of non-psychotic MDD, single or recurrent, and current Major Depressive Episode (MDE) based on the Mini-International Neuropsychiatric Interview (MINI) for DSM-5 administered at the first screening visit;
  • Participants diagnosed with treatment-resistant depression defined as individuals with a baseline HamD-17 score > 14 and that have not responded to two or more separate trials of antidepressants at an adequate dosage and duration (an antidepressant resistance rating score of three or more is considered an adequate trial) based on the Antidepressant Treatment History Form (ATHF) (Sackeim \& Sackeim, 2001); there is no upper limit on the number of treatment failures;
  • Ability to take oral medication;
  • Individuals with an eGFR above 40mL/min/1.73m2 and all blood work on clinical laboratory tests assessed as not clinically significant by study delegate physician at Screening (V1)
  • Individuals who are capable of making their partner pregnant or who are capable of becoming pregnant: use of condoms or highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation;
  • Individuals who are willing to and tapered off current antidepressants, antipsychotics, mood stabilizers, ketamine, esketamine, monoaminergic medicines, and stimulants used for augmentation of antidepressant therapy for a minimum of 2-weeks (or more depending on the medication) prior to Baseline (V2) and for the duration of the study and whose prescribing physician confirms that it is safe for them to do so;
  • Individuals who are willing to and have tapered off current inhibitors of 5'-diphospho-glucuronosyltransferase (UGT)1A9 and 1A10, aldehyde dehydrogenase inhibitors (ALDHs) and alcohol dehydrogenase inhibitors (ADHs) for a minimum of 2-weeks (or more depending on the medication) prior to Baseline (V2) and for the duration of the study and whose physician confirms that it is safe for them to do so;
  • Individuals must have a designated caregiver who is able to bring them home after treatment sessions and stay with them for at least 24 hours after psilocybin has been administered;
  • Individuals who are willing to not receive additional psychotherapy outside of the study throughout the active duration of the study; AND
  • Agreement to adhere to Lifestyle Considerations (section 4.5) throughout study duration.

Who cannot join

  • An individual who meets any of the following criteria will be excluded from participation in this clinical trial:
  • Pregnant as assessed by a urine pregnancy test at Screening (V1) and Baseline (V2) 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 Screening (V1);
  • Brain stimulation treatment within 6 months of Screening (V1);
  • Use of psychedelics within 6 months of Screening (V1);
  • Have initiated psychotherapy in the preceding 4 weeks prior to Screening (V1);
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  • Have a DSM-5 diagnosis of moderate to severe substance use disorder (recreational use of tobacco, alcohol, cannabis and prescribed opioids are permitted) within the preceding 6 months;
  • Have active suicidal ideation with intent and plan, certified by the Mental Health Act (MHA), determined by a study physician;
  • Any DSM-5 lifetime diagnosis of mania or hypomania, 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, borderline personality disorder, or neurocognitive disorder as determined by medical history and the MINI diagnostic interview;
  • Any first-degree relative with a diagnosis of schizophrenia-spectrum disorder; psychotic disorder (unless substance-induced or due to a medical condition), as determined by the family medical history form and discussions with the participant;
  • Presence of a relative or absolute contraindication to psilocybin, including a drug allergy, recent stroke history (within preceding six months) , uncontrolled hypertension (consistent blood pressure readings above 160/100 mmHg: measured twice with one hour between measurements), low blood pressure (blood pressure reading lower than 90/60mmHg), labile blood pressure (defined as episodes of both high and low blood pressure within a 24-hour period), recent myocardial infarction (within preceding six months), all types of cardiac arrhythmia, severe coronary artery disease (symptomatic with chest pain, angina heart palpitations or shortness of breath), or moderate to severe renal impairment (eGFR of below 40 mL/min ) or hepatic impairment (as a Child-Pugh score of B or C, determined through liver function tests);
  • Presence of baseline prolonged QTc (defined as greater than 450 milliseconds (ms) in men and greater than 460 ms in women) or Torsade de Pointes as measured by the ECG or a history of long QTc syndrome or related risk factors ;
  • 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. Contact the study team or a site near you to ask about taking part.

Emily Gilbert, MSc contact

416-535-8501 ext. 39570

emily.gilbert@camh.ca

Psychedelics Research contact

psychedelics.research@camh.ca

Canada2 sites, 2 recruiting

  • Toronto Western Hospital (University Health Network)

    Toronto, Ontario, M5T 2S8

    Noah Chisamore, 416-603-5106, Noah.Chisamore@uhn.ca

    Joshua Rosenblat, MD, MSc

    Recruiting

  • Centre for Addiction and Mental Health

    Toronto, Ontario, M6J1H4

    Emily Gilbert, MSc, 416-535-8501 ext. 39570, emily.gilbert@camh.ca

    Psychedelics Research, psychedelics.research@camh.ca

    Recruiting

Other trials in Canada

About this study

Official title: Evaluating the Role of Psilocybin Monitors in Psilocybin Therapy for Treatment Resistant Depression: A Pilot Randomized Clinical Trial

Psilocybin, the chemical component of "magic mushrooms", has been administered with psychological support in several randomized clinical trials (RCTs) showing large and sustained antidepressant effects.

The purpose of this study is to determine the role of psilocybin monitors on the effects of psilocybin therapy in adults with treatment resistant depression.

Read the detailed description

Psilocybin, the chemical component of "magic mushrooms", has been administered with psychological support in several randomized clinical trials (RCTs) showing large and sustained antidepressant effects.

The purpose of this study is to determine the role of psilocybin monitors on the effects of psilocybin therapy in adults with treatment resistant depression.

Being tested
Psilocybin
Keywords
Psilocybin, Psychedelics, Treatment resistant depression, Clinical Trial
Medical subject headings
Depressive Disorder, Treatment-Resistant

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07211438
Study groupRoleWhat they receive
Psilocybin + Safety Monitoring (PSM)ExperimentalPsilocybin 25 mg plus PSM
Receives: Drug: Psilocybin
Psilocybin + Psychedelic Assisted Therapy (PAT)Experimental25 mg of psilocybin plus PAT
Receives: Drug: Psilocybin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility of evaluating the role of psilocybin monitors in a clinical trial of psilocybin therapy for treatment resistant depression

    Percentage of participants recruited, randomized, and retained

    Measured: 24 months

Secondary outcomes (1)

  1. Tolerability and safety of administering psilocybin therapy (25 mg) for treatment resistant depression

    Type and number of adverse effects or serious adverse events

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Oct 2025
  2. Study start3 Jul 2026
  3. Primary completionJul 2028 (estimated)
  4. Study completionJan 2029 (estimated)

Resources

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
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07211438
Sponsor's protocol ID
5203
Acronym
PSI-TNT
Status last verified
Jul 2026
First submitted
2 Oct 2025
Last updated
21 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Psilocybin in people with Treatment-Resistant Depression, run by Centre for Addiction and Mental Health 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 16 inclusion and 13 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 21 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 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. 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 Emily Gilbert, MSc (416-535-8501 ext. 39570, emily.gilbert@camh.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility of evaluating the role of psilocybin monitors in a clinical trial of psilocybin therapy for treatment resistant depression (time frame: 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07211438.

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 21 Aug 2026.

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