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Psychedelic
Psilocybin for Depression
Phase 2
Waitlist Available
Led By Sharmin Ghaznavi, MD, PhD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
A score > 40 on the Wechsler Test of Adult Reading
McLean Screening Instrument for Borderline Personality Disorder (MSI-BPD) < 7 at Screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, the day before psilocybin administration and at 1 day, 1 week, 2 weeks, 3 weeks, 6 weeks, 9 weeks and 12 weeks after psilocybin administration.
Awards & highlights
Study Summary
This trial will study the effects of psilocybin on people with major depressive disorder who haven't responded to other treatments.
Who is the study for?
This trial is for adults aged 18-55 with treatment-resistant major depressive disorder (MDD), who have not improved after trying multiple antidepressants. Participants must be right-handed, able to read well, and have stopped all antidepressant medications at least two weeks before the study starts. They should also be under ongoing mental health care.Check my eligibility
What is being tested?
The study tests how a single dose of psilocybin affects self-focused thought patterns in people with MDD resistant to standard treatments. It involves brain scans (fMRI) to see changes in brain activity related to these thought processes.See study design
What are the potential side effects?
Psilocybin can cause headaches, nausea, increased heart rate and blood pressure, psychological distress or confusion during the experience ('bad trip'), and potential temporary changes in perception or mood.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
You have a score higher than 40 on a reading test for adults called the Wechsler Test.
Select...
Your score on the McLean Screening Instrument for Borderline Personality Disorder (MSI-BPD) needs to be less than 7 during the screening process.
Select...
You have been diagnosed with moderate or severe depression by a doctor using a special interview called the Mini International Neuropsychiatric Interview (MINI).
Select...
Your score on a test called the McLean Screening Instrument for Borderline Personality Disorder (MSI-BPD) needs to be less than 7 during the screening.
Select...
You have a high score on a reading test called the Wechsler Test.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, the day before psilocybin administration and at 1 day, 1 week, 2 weeks, 3 weeks, 6 weeks, 9 weeks and 12 weeks after psilocybin administration.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, the day before psilocybin administration and at 1 day, 1 week, 2 weeks, 3 weeks, 6 weeks, 9 weeks and 12 weeks after psilocybin administration.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Massachusetts General Hospital Rumination Questionnaire (MGH-RQ)
Change in Resting-State Functional Connectivity
Change in Self-Attribution Task performance
+1 moreSecondary outcome measures
Change in Behavior Rating Inventory of Executive Function - Adult Version (BRIEF)
Change in Cognitive Flexibility Inventory (CFI)
Change in Depression Implicit Attitudes Task (IAT)
+9 moreOther outcome measures
Change in Brief Fear of Negative Evaluation Scale - Second Version (BFNE-II)
Change in Personal Space Task
Change in Self-Consciousness Scale (SCS)
+3 moreSide effects data
From 2021 Phase 2 trial • 95 Patients • NCT020612939%
Nausea
7%
Pain
7%
Viral upper resp. tract infection
7%
Back pain
7%
Bronchitis
4%
Insomnia
4%
Suicidal Ideation
4%
Influenza
4%
Oropharyngeal pain
4%
Depression
4%
Diarrhea
4%
Headache
4%
Sinus headache
4%
Depressed mood
4%
Lower resp. tract congestion
4%
Alcohol withdrawal syndrome
2%
Pyrexia
2%
Vomiting
2%
Musculoskeletal pain
2%
Oedema
2%
Restlessness
2%
Peripheral swelling
2%
Hypoesthesia
2%
Rhinorrhea
2%
Fungal infection
2%
Thrombocytosis
2%
Eye infection
2%
Constipation
2%
Dermatitis contact
2%
Bronchitis bacterial
2%
Traumatic lung injury
2%
Hyponatremia
2%
Arthralgia
2%
Pain in extremity
2%
Dizziness
2%
Migraine
2%
Sedation
2%
Anger
2%
Anxiety
2%
Cough
2%
Sexual abuse
2%
Sinus congestion
2%
Malignant melanoma
2%
Endodontic procedure
2%
Mallory-Weiss Syndrom
2%
Anemia
2%
Influenza like Illness
2%
Gingivitis
2%
Arthoscopic surgery
100%
80%
60%
40%
20%
0%
Study treatment Arm
Diphenhydramine
Psilocybin
Trial Design
1Treatment groups
Experimental Treatment
Group I: PsilocybinExperimental Treatment1 Intervention
25mg of Psilocybin
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Psilocybin
Not yet FDA approved
Find a Location
Who is running the clinical trial?
Massachusetts General HospitalLead Sponsor
2,925 Previous Clinical Trials
13,197,889 Total Patients Enrolled
184 Trials studying Depression
29,510 Patients Enrolled for Depression
COMPASS PathwaysIndustry Sponsor
14 Previous Clinical Trials
1,558 Total Patients Enrolled
9 Trials studying Depression
880 Patients Enrolled for Depression
Sharmin Ghaznavi, MD, PhDPrincipal InvestigatorMassachusetts General Hospital
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a high score on a reading test called the Wechsler Test.You have had problems with alcohol or drugs within the past year, as determined by a standardized assessment called DSM-5.You have depression caused by other serious medical conditions.You are currently taking benzodiazepines every day.You have a score higher than 40 on a reading test for adults called the Wechsler Test.You have uncontrolled diabetes that requires insulin.You are right-handed according to a test called the Edinburg Handedness Inventory.You recently had a stroke or heart attack within the past year. You have high blood pressure or abnormal heart rhythms. You are currently taking medication to thin your blood. You have a condition called aneurysmal disease.You have been diagnosed by a doctor or mental health professional with moderate or severe depression using a specific interview called the MINI.Your score on the McLean Screening Instrument for Borderline Personality Disorder (MSI-BPD) needs to be less than 7 during the screening process.You have received electroconvulsive therapy or ketamine for your current condition in the past.You have a high risk of causing harm to others based on a clinical interview.Your score on the McLean Screening Instrument for Borderline Personality Disorder (MSI-BPD) needs to be less than 7 during the screening.You have a reading test score higher than 40 on the Wechsler Test of Adult Reading.You use your right hand more often than your left hand, according to a test called the Edinburg Handedness Inventory.You have been diagnosed with moderate or severe depression by a doctor using a special interview called the Mini International Neuropsychiatric Interview (MINI).You have a history of certain mental health conditions like schizophrenia, bipolar disorder, or personality disorders that may affect your ability to participate in the study.You have had thoughts of harming yourself or have engaged in self-harming behaviors within the past year, or a healthcare professional has determined that you are at significant risk of suicide.You have personal circumstances or behaviors that may make it difficult to build a connection or have a safe experience with psilocybin. Additionally, you have used psilocybin or other similar drugs within the past year.Your score on a test called the McLean Screening Instrument for Borderline Personality Disorder (MSI-BPD) needs to be less than 7 during the screening.You have a condition that causes seizures.You have been diagnosed with moderate to severe depression by a doctor using a structured interview called the MINI.You must be able to sign the informed consent form (ICF).You are between the ages of 18 and 55 years.
Research Study Groups:
This trial has the following groups:- Group 1: Psilocybin
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Depression Patient Testimony for trial: Trial Name: NCT05381974 — Phase 2
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are the targeted outcomes of this clinical research?
"The primary purpose of this research is to evaluate the alteration in MGH-RQ scores over baseline, administration day and 3/12 weeks post psilocybin. Secondary objectives include an examination of changes in IAT (implicit attitudes task), MADRS(Montgomery-Asberg Depression Rating Scale) and PSWQ (Penn State Worry Questionnaire)."
Answered by AI
Who is the target demographic for this research investigation?
"This clinical trial seeks to enroll 20 individuals, aged 18-55 and diagnosed with unipolar depression. Essential criteria include the ability to sign an Informed Consent Form (ICF), a score of at least moderate on the Mini International Neuropsychiatric Interview Version 7.02 (MINI) and Hamilton Depression Rating Scale - 17 item (HAM-D-17). Other eligibility requirements are failure to respond adequately to two or more pharmacological treatments for their current episode as determined by Massachusetts General Hospital Antidepressant Treatment History Response Questionnaire (MGH-ATRQ); a McLean Screening Instrument for Borderline personality disorder (MSI"
Answered by AI
Has the FDA sanctioned Psilocybin for medical use?
"Psilocybin's safety has been backed up by evidence, so it rated a 2. This Phase 2 trial lacks any data on efficacy though."
Answered by AI
What is the current number of participants enrolled in this investigation?
"Affirmative. According to information provided on clinicaltrials.gov, this medical experiment is actively recruiting participants; it was initially posted on September 15th 2022 and recently updated the day after. 20 subjects are being enrolled from a single location."
Answered by AI
Is this medical study open to geriatric patients?
"Eligibility for this trial requires participants to be within the age bracket of 18-55. Conversely, there are 105 studies in which those younger than 18 can take part and 591 trials that accommodate seniors over 65 years old."
Answered by AI
Are there still vacancies for the clinical trial available to participants?
"According to details hosted on clinicaltrials.gov, this trial is actively recruiting patients and has been since September 15th 2022. The study was recently updated on the 16th of that same month."
Answered by AI
Who else is applying?
What state do they live in?
Rhode Island
Connecticut
Massachusetts
Other
How old are they?
65+
18 - 65
What site did they apply to?
Athinoula A. Martinos Center for Biomedical Imaging
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
3+
0
Why did patients apply to this trial?
Im suffering from depression. I have tried almost all the types of antidepressants without relief.
PatientReceived no prior treatments
I am open to different avenues then psychotropics to treat depression,. Have seen and read about the drug and am interested in the trials. I have depression and addictions that I would like relief from.
PatientReceived 2+ prior treatments
I'm 60 years old and have suffered from severe depression since I was 13, I have PTSD from 2016and a mild TBI. I just turned 60 and I would be.
PatientReceived 2+ prior treatments
What questions have other patients asked about this trial?
When do you start recruiting? How do I know if I qualify for the trial? I live 2 hours away. Can at least some visits be done virtually?
PatientReceived 2+ prior treatments
How responsive is this trial?
Average response time
- < 2 Days
Typically responds via
Phone Call
Email
Most responsive sites:
- Athinoula A. Martinos Center for Biomedical Imaging: < 24 hours
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