The Effects of Psilocybin on Self-Focus and Self-Related Processing in Treatment Resistant MDD

NCT05381974•Massachusetts General Hospital

Summary

This open-label fMRI study will assess the effects of a single dose of psilocybin on rumination and the neural correlates of rumination in individuals with treatment-resistant major depressive disorder.

Eligibility

Age

18 - 55 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Must be able to sign the informed consent form (ICF).
•2. Be 18-55 years of age at screening.
•3. At least moderate MDD based on clinical assessment and a structured clinical interview, the Mini International Neuropsychiatric Interview Version 7.02 (MINI).
•4. Hamilton Depression Rating Scale - 17 item (HAM-D-17) score ≥ 18 at Screening and at Baseline.
•5. Failure to respond to an adequate dose and duration of 2, 3, or 4 pharmacological treatments for the current episode as determined through the Massachusetts General Hospital Antidepressant Treatment History Response Questionnaire (MGH-ATRQ) and using the supplementary advice on additional antidepressants not included in MGH-ATRQ. Augmentation with an add-on treatment counts as a second treatment, provided it is approved for the adjunctive treatment of MDD.
•6. McLean Screening Instrument for Borderline Personality Disorder (MSI-BPD) \< 7 at Screening.
•7. Have successfully discontinued all antidepressant medications at least 2 weeks prior to Baseline Scan. (Please note: once enrolled in the study, participants will have to successfully undergo a taper off of all psychotropic medications under the supervision of a study psychiatrist and in coordination with their treatment team).
•8. A score \> 40 on the Wechsler Test of Adult Reading.
•9. Be right-handed as determined by the Edinburg Handedness Inventory.
•10. Ability to complete all protocol required assessment tools without any assistance or alteration to the copyrighted assessments, and to comply with all study visits.
+1 more criteria

Exclusion Criteria

•1. Current, past history, or family history, of schizophrenia, psychotic disorder (unless substance induced or due to a medical condition), bipolar disorder, delusional disorder, paranoid personality disorder, schizoaffective disorder, borderline personality disorder, or any serious psychiatric comorbidity as assessed by medical history and a structured clinical interview (version 7.0.2 MINI).
•2. Positive MR screen (e.g., metal implant, claustrophobia, etc).
•3. Prior electroconvulsive therapy and/or ketamine for current episode.
•4. Current cognitive behavioral therapy (CBT) that will not remain stable for the duration of the study. CBT cannot be initiated within 21 days of Baseline.
•5. Current (within the last year) alcohol or substance abuse as informed by DSM-5 at Screening.
•6. Significant suicide risk as defined by (1) suicidal ideation as endorsed on items 4 or 5 on the Columbia-Suicide Severity Rating Scale (C-SSRS) within the past year, at Screening or at Baseline, or; (2) suicidal behaviors within the past year, or; (3) clinical assessment of significant suicidal risk during clinical interview.
•7. Significant homicide risk as defined by clinical interview.
•8. Depression secondary to other severe medical conditions.
•9. Currently taking benzodiazepines daily.
•10. Other personal circumstances and behavior judged to be incompatible with establishment of rapport or safe exposure to psilocybin, as well as exposure to psilocybin or other psychedelics within one year of screening.
+9 more criteria

Locations (1)

Athinoula A. Martinos Center for Biomedical Imaging

Charlestown, Massachusetts, United States

Key Dates

Start Date

September 15, 2022

Primary Completion Date

June 1, 2023

Completion Date

June 1, 2023

Last Updated

January 24, 2024

Conditions

Treatment-Resistant Major Depressive Disorder

Interventions

Psilocybin

DRUG

Virtual Reality-Based Mindfulness as an Adjunct to Treatment as Usual in Treatment-Resistant Depression

NCT07422519

Depression - Major Depressive DisorderDepression Disorder+2 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 24, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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