RecruitingMajor Depressive Disorder
The Effects of Psilocybin on Self-Focus and Self-Related Processing in Major Depressive Disorder
Eligible age
18–55 yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
See if you qualify for this study
Answer a few quick questions about your location and health. Takes about a minute.
About this study
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.
Sponsor: Sharmin Ghaznavi
You may qualify if…
- ✓ 1. Must be able to sign the informed consent form (ICF). Participants will demonstrate capacity to provide informed consent by demonstrated understanding of the protocol and what their involvement in the study requires from them.
- ✓ 2. Be 18-55 years of age at screening.
- ✓ 3. At least moderate Major Depressive Disorder (MDD; single or recurrent episode as informed by Diagnostic and Statistical Manual Version 5 (DSM-V); if single episode, duration of ≥ 3 months and ≤ 3 years) based on clinical assessment and a structured clinical interview, the Mini International Neuropsychiatric Interview Version 7.02 (MINI).43
- ✓ 4. Structured Interview Guide for the Hamilton Depression Rating Scale with Atypical Depression Supplement (SIGH-ADS)44 score ≥ 18 at Screening and at Baseline.
- ✓ 5. Failure to respond to an adequate dose and duration of 1, 2, 3, or 4 pharmacological treatments for the current episode as determined through the Massachusetts General Hospital Antidepressant Treatment History Response Questionnaire (MGH-ATRQ)45 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. Participants will also 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, which will be completed at least 2 weeks prior to Baseline Scan. Please see below regarding details about discontinuation of antidepressants.
- ✓ 8. A score \> 40 on the Wechsler Test of Adult Reading.46
You may not qualify if…
- ✕ Patients meeting any of the following criteria are to be excluded from the study:
- ✕ 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 Magnetic Resonance 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)49 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.
Where it's recruiting
Massachusetts
Charlestown
Source: ClinicalTrials.gov · NCT06247839 · last updated 2026-07-17