Actively Recruiting
The Effects of Psilocybin on Self-Focus and Self-Related Processing in Major Depressive Disorder
Led by Sharmin Ghaznavi · Updated on 2025-05-06
20
Participants Needed
1
Research Sites
94 weeks
Total Duration
On this page
Sponsors
S
Sharmin Ghaznavi
Lead Sponsor
C
COMPASS Pathways
Collaborating Sponsor
AI-Summary
What this Trial Is About
This open-label functional Magnetic Resonance Imaging (fMRI) study will assess the effects of a single dose of psilocybin on rumination and the neural correlates of rumination in individuals with major depressive disorder.
CONDITIONS
Official Title
The Effects of Psilocybin on Self-Focus and Self-Related Processing in Major Depressive Disorder
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to provide informed consent and understand the study requirements
- Age between 18 and 55 years at screening
- Diagnosed with at least moderate Major Depressive Disorder (single or recurrent episode) lasting 3 months to 3 years if single episode
- Score of 18 or higher on the Hamilton Depression Rating Scale with Atypical Depression Supplement at screening and baseline
- Have not responded to 1 to 4 adequate pharmacological treatments for the current depressive episode
- Score less than 7 on the McLean Screening Instrument for Borderline Personality Disorder at screening
- Completed supervised tapering off of all psychotropic medications at least 2 weeks before baseline scan
- Score over 40 on the Wechsler Test of Adult Reading
- Right-handed as determined by the Edinburgh Handedness Inventory
- Able to complete all required assessments independently and comply with study visits
- Have ongoing established mental health care
You will not qualify if you...
- Current, past, or family history of schizophrenia, psychotic disorders (unless substance induced or medical), bipolar disorder, delusional disorder, paranoid personality disorder, schizoaffective disorder, borderline personality disorder, or serious psychiatric comorbidity
- Positive MRI screening due to metal implant, claustrophobia, or similar issues
- Prior electroconvulsive therapy or ketamine treatment for current episode
- Current cognitive behavioral therapy (CBT) that is not stable throughout the study or started within 21 days of baseline
- Alcohol or substance abuse within the last year
- Significant suicide risk as assessed by clinical interview or suicide rating scales within the past year
- Significant homicide risk as assessed by clinical interview
- Depression caused by other serious medical conditions
- Daily use of benzodiazepines
- Personal behavior or circumstances incompatible with safe psilocybin exposure; use of psilocybin or psychedelics within one year
- Women who are pregnant, breastfeeding, or planning pregnancy; sexually active women must use effective contraception and have negative pregnancy tests at screening and day before treatment
- Cardiovascular conditions including recent stroke or heart attack within one year, high blood pressure, arrhythmia, anticoagulant therapy, or aneurysm
- Uncontrolled insulin-dependent diabetes
- Seizure disorders
- Positive drug screen for illicit or abused drugs at screening and day before treatment
- History of brain surgery, meningitis, degenerative CNS disorders, epilepsy, intellectual disability, significant head trauma within 2 years, or CNS injury
- Physical conditions that may pose risk or interfere with study interpretation
- Current enrollment or participation in investigational drug/device studies within 6 months
- Current enrollment or participation in interventional depression studies within 6 months
- Non-native English speakers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Athinoula A. Martinos Center for Biomedical Imaging
Charlestown, Massachusetts, United States, 02129
Actively Recruiting
Research Team
S
Sarah G Richter, M.A.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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