The Effects of Psilocybin on Self-Focus and Self-Related Processing in Major Depressive Disorder
ConditionMajor Depressive Disorder
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-55
SponsorSharmin Ghaznavi
About this trial
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.
Eligibility criteria
Qualifiers
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.
Be 18-55 years of age at screening.
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
Structured Interview Guide for the Hamilton Depression Rating Scale with Atypical Depression Supplement (SIGH-ADS)44 score ≥ 18 at Screening and at Baseline.
Disqualifiers
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).
Positive Magnetic Resonance screen (e.g., metal implant, claustrophobia, etc).
Prior electroconvulsive therapy and/or ketamine for current episode.
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.
Trial design
Treatments tested in this trial
- Psilocybin
Treatment groups
20 Participants
are divided into 1 treatment groupSponsors and collaborators
Sharmin Ghaznavi
Lead sponsor
Massachusetts General Hospital
Sponsor institution
COMPASS Pathways
Collaborator
Source ClinicalTrials.gov