Major Depressive Disorder study: Psilocybin
Official title Psilocybin-assisted Therapy for Comorbid Major Depressive Disorder and Alcohol Use Disorder
ClinicalTrials.gov ID: NCT07405606
What this study is testing
What is Psilocybin 25 mg?
An investigational oral psychedelic medicine being studied for Major Depressive Disorder with Alcohol Use Disorder.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study wants to see if psilocybin therapy is safe and feasible for people with both major depressive disorder and alcohol use disorder. It will compare dropout rates and serious side‑effects between the psilocybin and placebo groups.
- Who it's for
- Adults who have both major depressive disorder and alcohol use disorder
- What's involved
- Participants are randomly assigned to receive either 25 mg psilocybin or a placebo. They will attend 14 visits, some in person and some remotely, and receive therapy sessions around five of those visits.
- Time commitment
- The study lasts about 14 visits over several months; participants must attend all scheduled visits and complete the study tasks.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- 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...
- Stated willingness to comply with all study procedures;
- Be deemed in health compatible with the study procedures according to study physician;
You likely can't join if
- 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...
- Presence of a relative or absolute contraindication to psilocybin, including a drug allergy, recent stroke history, uncontrolled hypertension (over...
- Diagnosis of cirrhosis, AST or ALT elevations \> 3x upper limit of normal
- Any DSM-5 lifetime diagnosis of a schizophrenia-spectrum disorder; obsessive-compulsive disorder, psychotic disorder (unless substance induced or due...
- Any first-degree relative with a diagnosis of schizophrenia-spectrum disorder
- Clinical Institute Withdrawal Assessment for Alcohol, revised (CIWA-Ar) score \> 9, or any other indication that the participant may experience...
See the full eligibility criteria
Who can 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;
- 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...
- 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...
- 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...
- Agreement to adhere to Lifestyle Considerations (section 4.5) throughout study duration.
What rules you out
- 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...
- 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...
- 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...
- Any first-degree relative with a diagnosis of schizophrenia-spectrum disorder; psychotic disorder (unless substance-induced or due to a medical condition)
- 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...
- 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...
- Participants that are responding to anti-alcohol or anti-craving medications
The study team makes the final eligibility decision.
Where it is enrolling
- Toronto, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Toronto, Ontario, Canada. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.