The Effects of Psilocybin on Self-Focus and Self-Related Processing in Major Depressive Disorder

This open-label interventional trial (n=20) will assess the effects of a single dose of psilocybin (25mg) on rumination and its neural correlates in individuals diagnosed with major depressive disorder (MDD).

Conducted at Massachusetts General Hospital, this phase III trial aims to recruit participants aged 18-55 with at least moderate MDD. Participants must have failed to respond to multiple pharmacological treatments for the current depressive episode. Exclusion criteria include a history of psychotic disorders, substance abuse, or certain medical conditions. The study will involve a single group receiving 25mg of psilocybin.

The primary outcome measures include changes in rumination assessed by the Massachusetts General Hospital Rumination Questionnaire (MGH-RQ) and resting-state functional connectivity measured by functional MRI scans.

Secondary outcome measures include changes in depression severity assessed by various scales such as the Montgomery-Asberg Depression Rating Scale (MADRS) and the Quick Inventory of Depressive Symptomatology Self Report (QIDS-SR-16).

The study’s primary completion date is estimated to be in June 2026.

Topic Depression Neuroscience
Compound Psilocybin
Country United States of America
Visit trial
Status Not yet recruiting
Results Published No
Start date 01 April 2024
End date 30 June 2026
Phase Phase III
Design Open
Type Interventional
Generation First
Participants 20
Sex All
Age 18- 55
Therapy No

Trial Details

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.

NCT Number NCT06247839

Sponsors & Collaborators

Massachusetts General Hospital
Massachusettes General Hospital has launched the MGH Center for the Neuroscience of Psychedelics. The announcement has now been done via YouTube, and the formal launch will be in fall 2020.

Data attribution

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