Major Depressive Disorder (MDD)Phase 2NCT07405606
Psilocybin-assisted Therapy for Comorbid Major Depressive Disorder and Alcohol Use Disorder
A Phase 2 study testing Psilocybin 25 mg in people with Major Depressive Disorder (MDD) and Alcohol Use Disorder (AUD), run by Centre for Addiction and Mental Health at 1 site in Canada.
Trial summary
The goal of this clinical trial is to determine the safety and efficacy of psilocybin assisted Therapy (PAT) in individuals with comorbid Major Depressive Disorder (MDD) and Alcohol Use Disorder (AUD). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depressive Disorder (MDD), Alcohol Use Disorder (AUD)
- What is being tested?
- Psilocybin 25 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 23 Mar 2026to Jun 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be between the ages of 18-65
- Must be deemed to have capacity to provide informed consent;
- 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;
- Stated willingness to comply with all study procedures;
- Be deemed in health compatible with the study procedures according to study physician;
- Ability to take oral medication and be willing to adhere to the PAT regimen;
Show all 13Show fewer
- Individuals who are capable of becoming pregnant: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation;
- Fulfil Diagnostic and Statistical Manual of Mental Disorders (5th Edition) (DSM-5) criteria for a primary diagnosis of current single or recurrent episodes of MDD of at least moderate severity but without psychotic features and a comorbid AUD diagnosis (moderate or severe) using the SCID-5;
- A score of at least 14 on the Hamilton Depression Rating Scale for Depression (HAMD);
- Participants should not be interested in initiating standard pharmacotherapies for MDD or AUD. The need to start/resume standard pharmacotherapies will be reassessed at Week 6.
- Individuals who are willing to and tapered off current antidepressant or IMAOs, antipsychotic and anti-alcohol/anti-craving medications 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 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;
- Agreement to adhere to Lifestyle Considerations (section 4.5) throughout study duration.
Who cannot join
- 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;
- Presence of a relative or absolute contraindication to psilocybin, including a drug allergy, recent stroke history, uncontrolled hypertension (over 160/100 mmHG), low or labile blood pressure, recent myocardial infarction, cardiac arrhythmic, severe coronary artery disease, or moderate to severe renal or hepatic impairment.
- Diagnosis of cirrhosis, AST or ALT elevations > 3x upper limit of normal; significant abnormal liver function that would preclude administration of psilocybin based on the judgement of the QI (assessed notably by bilirubin, albumin, alkaline phosphatase, GGT, and INR functions)
- 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, borderline personality disorder, or neurocognitive disorder as determined by medical history and the SCID-5 clinical interview;
- 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;
- Clinical Institute Withdrawal Assessment for Alcohol, revised (CIWA-Ar) score > 9, or any other indication that the participant may experience medically complicated withdrawal from alcohol, such as a score of ≥4 in the Prediction of Alcohol Withdrawal Severity Scale.
Show all 14Show fewer
- Use benzodiazepines (with the exception of use of up to 2mg of lorazepam equivalent per day for insomnia and anxiety if it is not taken within 12 hours before the psilocybin dose (Week 2).
- Have a DSM-5 diagnosis of substance use disorder (excluding alcohol, cannabis, tobacco and caffeine) within the preceding 6 months;
- Presence of baseline prolonged QTc (more than 0.45 seconds for males and 0.47 seconds for females) or Torsade de Pointes as measured by the ECG or a history of long QTc syndrome or related risk factors;
- Use of aldehyde dehydrogenase (ALDH) inhibitors and UDG modulators;
- Use of hallucinogens in the past 5 years; or total hallucinogen use ≥10 times)
- Current suicidality risk as indicated during the conduct of the Columbia Suicide Severity Rating Scale (C-SSRS) with concurrence after a study physician's evaluation if the response to C-SSRS questions 1 or 2 is "yes")
- 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.
- Participants that are responding to anti-alcohol or anti-craving medications
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
Centre for Addiction and Mental Health
Toronto, Ontario
Bernard Le Foll, +14165358501 ext. 33111, bernard.lefoll@camh.ca
About this study
Official title: Psilocybin-assisted Therapy for Comorbid Major Depressive Disorder and Alcohol Use Disorder: A Pilot Randomized Clinical Trial
The goal of this clinical trial is to determine the safety and efficacy of psilocybin assisted Therapy (PAT) in individuals with comorbid Major Depressive Disorder (MDD) and Alcohol Use Disorder (AUD). The main question it aims to answer is:
- What is the feasibility and safety of administering PAT in adults with MDD-AUD by evaluating recruitment, retention, tolerability, and safety?
Read more
Researchers will compare the psilocybin (25 mg) and placebo groups to see if there are any significant differences in frequency of dropouts or serious adverse events.
Participants will:
- be randomized to receive either psilocybin (25 mg) or placebo
- visit the site (in-person and remotely) for a total of 14 times to complete study tasks
- receive psilocybin-assisted therapy (PAT) at five various timepoints
- Being tested
- Psilocybin 25 mg, Placebo
- Keywords
- depression, psilocybin, alcohol use disorder
- Medical subject headings
- Depressive Disorder, Major, Alcoholism, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psilocybin 25 mgDrug
Participants will orally consume Psilocybin (25 mg) with water.
PlaceboDrug
Participants will orally consume placebo matching the intervention with water.
| Study group | Role | What they receive |
|---|---|---|
| Psilocybin (25 mg) | Experimental | Participant is administered one oral capsule (25 mg psilocybin) with water. Receives: Drug: Psilocybin 25 mg |
| Placebo | Placebo comparator | Participant is administered one oral capsule (0 mg psilocybin) with water. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence
Although all administration of psilocybin will be administered by qualified staff, the investigators will measure adherence through visit compliance (i.e., missed visits).
Measured: Week 2 (Visit 4)
Montgomery-Asberg Depression Rating Scale (MADRS)
Used to assess changes in depressive symptoms on a 10-item scale with each item rated on a scale of 0-6. Higher scores indicate greater severity of symptoms.
Measured: Baseline; 1-day post dose; 1-week post dose; 2-week post dose; 3-week post dose; 4-week post dose; week 10; week 14; week 18; week 22; week 26.
Hamilton Depression Rating Scale (HAMD-17)
Used to assess changes in depressive symptoms using 3-point (0-2) or 5-point (0-4) Likert scales. Higher scores indicate greater severity of symptoms.
Measured: 4-week post dose; week 26.
Quick Inventory of Depressive Symptomatology - Self Report (QUIDS-SR)
Used to assess changes in depressive symptoms with a minimum score of 0 to a maximum score of 27.
Measured: Baseline; 1-day post dose; 1-week post dose; 2-week post dose; 3-week post dose; 4-week post dose; week 10; week 14; week 18; week 22; week 26.
Alcohol Timeline Followback (TLFB)
To monitor alcohol consumption, heavy drinking days, drinks per day, drinks per drinking day, percent very heavy drinking days, percent participants with no heavy drinking days, and abstinent percent will be measured.
Measured: Baseline; week 2 (visit 3); 1-day post dose; 1-week post dose; 2-week post dose; 3-week post dose; 4-week post dose; week 10; week 14; week 18; week 22; week 26.
Clinical Institute Withdrawal Assessment (CIWA)
Used to assess alcohol withdrawal symptoms. Scores range from 0 to 67 with higher scores indicating greater severity of withdrawal symptoms.
Measured: Baseline; week 2 (visit 3); week 2 (visit 4); 1-day post dose; 1-week post dose; 2-week post dose; 3-week post dose; 4-week post dose; week 10; week 14; week 18; week 22; week 26.
Prediction of Alcohol Withdrawal Severity Scale (PAWSS)
Used to assess risk of alcohol withdrawal symptoms using a 10-item scale with the total score ranging from 0 to 10. Higher scores indicate greater risk of withdrawal symptoms.
Measured: Baseline; 1-day post dose; 1-week post dose; 2-week post dose; 3-week post dose; 4-week post dose; week 10; week 14; week 18; week 22; week 26.
Penn Alcohol Craving Scale (PACS)
Used to assess history, frequency, and consequences of alcohol use. Scores range from 0 to 30 with higher scores indicating greater craving.
Measured: Baseline; 1-day post dose; 1-week post dose; 2-week post dose; 3-week post dose; 4-week post dose; week 10; week 14; week 18; week 22; week 26.
Addiction Severity Index (ASI)
Used to assess history, frequency, and consequences of alcohol use
Measured: Baseline; 1-day post dose; 1-week post dose; 2-week post dose; 3-week post dose; 4-week post dose; week 10; week 14; week 18; week 22; week 26.
Secondary outcomes (12)
5 Dimensional Altered States of Consciousness (5-DASC)
Used to assess subjective effects of psilocybin. Minimum value of 0 to maximum value of 100, with higher scores representing greater reports of alterations to normal waking consciousness.
Measured: Week 2 (visit 4).
Psychological Insight Questionnaire (PIQ)
Used to assess subjective effects of psilocybin. Contains 23 items rated on a 5-point Likert scale. Higher scores generally indicate greater intensity of psychological insight.
Measured: Week 2 (visit 4).
Mystical Experience Questionnaire (MEQ)
Used to assess subjective effects of psilocybin. Contains 30 items rated on a 5-point Likert scale. Higher scores indicate greater mystical experience.
Measured: Week 2 (visit 4).
Challenging Experience Questionnaire (CEQ)
Used to assess subjective effects of psilocybin. Contains 26 items rated on a 5-point Likert scale. Higher scores generally indicate more challenging experience or distress.
Measured: Week 2 (visit 4).
General Anxiety Disorder-7th edition (GAD-7)
Used to assess anxiety-related symptoms. Scores range from 0 to 21 with higher scores indicating greater severity of anxiety symptoms.
Measured: Baseline; week 26.
State Trait Anxiety Index (STAI)
Used to assess anxiety-related symptoms. Scores range from 20 to 80 with higher scores indicating greater severity of anxiety symptoms.
Measured: Baseline; week 26.
World Health Organization Quality of Life Questionnaire Brief Version (WHOQOL-BREF)
Used to assess overall quality of life. Scores range from 0 to 100 with higher scores indicating greater quality of life.
Measured: Baseline; week 26.
Big Five Inventory (BFI)
Used to assess personality. Contains 44 items with each item rated on a five-point Likert scale from 1 (disagree a lot) to 5 (agree a lot). Higher scores in each trait indicates stronger association to the trait.
Measured: Baseline; week 26.
Pittsburgh Sleep Quality Index (PSQI)
Used to assess quality of sleep. Score ranges from 0 to 21 with higher scores indicating greater disturbance to sleep.
Measured: Baseline; week 26.
Acceptance & Action Questionnaire II (AAQ-II)
Used to assess psychological flexibility. There are 7-items each rated on a 7-point Likert scale. Higher scores indicate greater psychological inflexibility.
Measured: Baseline; 1-day post dose; 1-week post dose; 2-week post dose; 3-week post-dose; 4-week post-dose; week 10; week 14; week 18; week 22; week 26.
Stanford Expectations of Treatment Scale (SETS)
Used to assess participants' positive and negative treatment expectancies. Rated on a 7-item Likert scale, with minimum score of 6, and maximum score of 42. Higher scores generally indicate greater expectations for positive expectancy scores and greater concerns for negative expectancy scores.
Measured: Baseline
Working Alliance Inventory (WAI)
Used to assess the participants' therapeutic relationship with their therapists. Scores range from 12 to 60 with higher scores indicating stronger therapeutic alliance.
Measured: Week 2 (visit 3); 1-day post dose; 1-week post dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2026
- Study start23 Mar 2026
- Primary completionMar 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive Disorder (MDD)Studies of the same condition, open and under way.
- More trials run by Centre for Addiction and Mental HealthThe 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre for Addiction and Mental Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bernard Le Foll, Centre for Addiction and Mental Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07405606
- Sponsor's protocol ID
- 071/2023
- Status last verified
- Oct 2026
- First submitted
- 29 Jan 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psilocybin-assisted Therapy for Comorbid Major Depressive Disorder and Alcohol Use Disorder: A Pilot Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07405606
- Acronym / sponsor ID
- 071/2023
- Keywords
- depression, psilocybin, alcohol use disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Centre for Addiction and Mental HealthUniversity, hospital or other
- Study start
- 23 Mar 2026 (actual)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 12 Feb 2026 (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 goal of this clinical trial is to determine the safety and efficacy of psilocybin assisted Therapy (PAT) in individuals with comorbid Major Depressive Disorder (MDD) and Alcohol Use Disorder (AUD). The main question it aims to answer is:
- What is the feasibility and safety of administering PAT in adults with MDD-AUD by evaluating recruitment, retention, tolerability, and safety?
Researchers will compare the psilocybin (25 mg) and placebo groups to see if there are any significant differences in frequency of dropouts or serious adverse events.
Participants will:
- be randomized to receive either psilocybin (25 mg) or placebo
- visit the site (in-person and remotely) for a total of 14 times to complete study tasks
- receive psilocybin-assisted therapy (PAT) at five various timepoints
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Psilocybin (25 mg) | Experimental | Drug: Psilocybin 25 mgParticipant is administered one oral capsule (25 mg psilocybin) with water. |
| Placebo | Placebo comparator | Drug: PlaceboParticipant is administered one oral capsule (0 mg psilocybin) with water. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Be between the ages of 18-65
- Must be deemed to have capacity to provide informed consent;
- 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;
- Stated willingness to comply with all study procedures;
- Be deemed in health compatible with the study procedures according to study physician;
Key exclusion criteria (14 listed)
- 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;
- Presence of a relative or absolute contraindication to psilocybin, including a drug allergy, recent stroke history, uncontrolled hypertension (over 160/100 mmHG), low or labile blood pressure, recent myocardial infarction, cardiac arrhythmic, severe coronary artery disease, or moderate to severe renal or hepatic impairment.
- Diagnosis of cirrhosis, AST or ALT elevations > 3x upper limit of normal; significant abnormal liver function that would preclude administration of psilocybin based on the judgement of the QI (assessed notably by bilirubin, albumin, alkaline phosphatase, GGT, and INR functions)
- 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, borderline personality disorder, or neurocognitive disorder as determined by medical history and the SCID-5 clinical interview;
- 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;
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 25 mgParticipants will orally consume Psilocybin (25 mg) with water. | Drug | Psilocybin (25 mg) |
| PlaceboParticipants will orally consume placebo matching the intervention with water. | Drug | Placebo |
Primary outcome
Adherence
Time frame: Week 2 (Visit 4)
Although all administration of psilocybin will be administered by qualified staff, the investigators will measure adherence through visit compliance (i.e., missed visits).
Montgomery-Asberg Depression Rating Scale (MADRS)
Time frame: Baseline; 1-day post dose; 1-week post dose; 2-week post dose; 3-week post dose; 4-week post dose; week 10; week 14; week 18; week 22; week 26.
Used to assess changes in depressive symptoms on a 10-item scale with each item rated on a scale of 0-6. Higher scores indicate greater severity of symptoms.
Hamilton Depression Rating Scale (HAMD-17)
Time frame: 4-week post dose; week 26.
Used to assess changes in depressive symptoms using 3-point (0-2) or 5-point (0-4) Likert scales. Higher scores indicate greater severity of symptoms.
Quick Inventory of Depressive Symptomatology - Self Report (QUIDS-SR)
Time frame: Baseline; 1-day post dose; 1-week post dose; 2-week post dose; 3-week post dose; 4-week post dose; week 10; week 14; week 18; week 22; week 26.
Used to assess changes in depressive symptoms with a minimum score of 0 to a maximum score of 27.
Alcohol Timeline Followback (TLFB)
Time frame: Baseline; week 2 (visit 3); 1-day post dose; 1-week post dose; 2-week post dose; 3-week post dose; 4-week post dose; week 10; week 14; week 18; week 22; week 26.
To monitor alcohol consumption, heavy drinking days, drinks per day, drinks per drinking day, percent very heavy drinking days, percent participants with no heavy drinking days, and abstinent percent will be measured.
Clinical Institute Withdrawal Assessment (CIWA)
Time frame: Baseline; week 2 (visit 3); week 2 (visit 4); 1-day post dose; 1-week post dose; 2-week post dose; 3-week post dose; 4-week post dose; week 10; week 14; week 18; week 22; week 26.
Used to assess alcohol withdrawal symptoms. Scores range from 0 to 67 with higher scores indicating greater severity of withdrawal symptoms.
Prediction of Alcohol Withdrawal Severity Scale (PAWSS)
Time frame: Baseline; 1-day post dose; 1-week post dose; 2-week post dose; 3-week post dose; 4-week post dose; week 10; week 14; week 18; week 22; week 26.
Used to assess risk of alcohol withdrawal symptoms using a 10-item scale with the total score ranging from 0 to 10. Higher scores indicate greater risk of withdrawal symptoms.
Penn Alcohol Craving Scale (PACS)
Time frame: Baseline; 1-day post dose; 1-week post dose; 2-week post dose; 3-week post dose; 4-week post dose; week 10; week 14; week 18; week 22; week 26.
Used to assess history, frequency, and consequences of alcohol use. Scores range from 0 to 30 with higher scores indicating greater craving.
Addiction Severity Index (ASI)
Time frame: Baseline; 1-day post dose; 1-week post dose; 2-week post dose; 3-week post dose; 4-week post dose; week 10; week 14; week 18; week 22; week 26.
Used to assess history, frequency, and consequences of alcohol use
12 secondary outcomes
5 Dimensional Altered States of Consciousness (5-DASC)
Time frame: Week 2 (visit 4).
Psychological Insight Questionnaire (PIQ)
Time frame: Week 2 (visit 4).
Mystical Experience Questionnaire (MEQ)
Time frame: Week 2 (visit 4).
Challenging Experience Questionnaire (CEQ)
Time frame: Week 2 (visit 4).
General Anxiety Disorder-7th edition (GAD-7)
Time frame: Baseline; week 26.
State Trait Anxiety Index (STAI)
Time frame: Baseline; week 26.
World Health Organization Quality of Life Questionnaire Brief Version (WHOQOL-BREF)
Time frame: Baseline; week 26.
Big Five Inventory (BFI)
Time frame: Baseline; week 26.
Pittsburgh Sleep Quality Index (PSQI)
Time frame: Baseline; week 26.
Acceptance & Action Questionnaire II (AAQ-II)
Time frame: Baseline; 1-day post dose; 1-week post dose; 2-week post dose; 3-week post-dose; 4-week post-dose; week 10; week 14; week 18; week 22; week 26.
Stanford Expectations of Treatment Scale (SETS)
Time frame: Baseline
Working Alliance Inventory (WAI)
Time frame: Week 2 (visit 3); 1-day post dose; 1-week post dose.
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 26 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Major Depressive Disorder (MDD)
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
RecruitingPhase 4
Biomarker-Guided Antidepressant Selection
Depression - Major Depressive Disorder, Treatment-resistant Depression (TRD)
Recruiting
Targeting Network Dysfunction in Apathy of Late-life Depression Using Digital Therapeutics
Major Depressive Disorder, Apathy
Not yet recruiting
Acute Intermittent Hypoxia Therapy for Depression
Major Depressive Disorder (MDD)
RecruitingPhase 2
Psilocybin With Pimavanserin Compared to Psilocybin Alone for the Treatment of Major Depressive Disorder
Major Depressive Disorder
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 25 mg in people with Major Depressive Disorder (MDD) and Alcohol Use Disorder (AUD), run by Centre for Addiction and Mental Health 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 13 inclusion and 14 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 26 Oct 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 Bernard Le Foll (+14165358501 ext. 33111, bernard.lefoll@camh.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence (time frame: Week 2 (Visit 4)). The study lists 9 primary outcomes in all. 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 26 Oct 2026.