Clinical, Neurocognitive, and Emotional Effects of Psilocybin in Depressed Patients – Proof of Concept

Effects of serotonin 2A/1A receptor stimulation by psilocybin on mood and emotion processing in major depressive disorder: a randomized double-blind placebo-controlled study

Status Completed
Results Published Yes
Start date 11 March 2019
End date 12 April 2022
Chance of happening 100%
Phase Phase II
Design Blinded
Type Interventional
Generation First
Participants 60
Sex All
Age 18- 60
Therapy No

Trial Details



NCT Number NCT03715127

Sponsors & Collaborators

Usona Institute
The Usona Institute was founded by Bill Linton and Malynn Utzinger. Currently, 18 people are associated with it. The institute is a non-profit that sponsors psilocybin research (and is funded by sponsors/philanthropists).

The Emmes Company
This company doesn't have a full profile yet, it is linked to a clinical trial.

Signant Health
This company doesn't have a full profile yet, it is linked to a clinical trial.

Papers

Single-dose psilocybin-assisted therapy in major depressive disorder: A placebo-controlled, double-blind, randomised clinical trial
This double-blind placebo-controlled study (n=56) found that one psilocybin-assisted therapy (16mg/70kg, 2 prep + 3 integration meetings) session significantly reduced depressive symptoms (MADRS & BDI) in those suffering from a major depressive disorder (MDD, n=26). Fourteen days after the intervention, 54% of those in the psilocybin group met remission criteria (<10 on MADRS).

Measures Used

Montgomery-Asberg Depression Rating Scale
A ten-item diagnostic questionnaire used to measure the severity of depressive symptoms in patients with mood disorders.

Beck Depression Inventory
The Beck Depression Inventory (BDI) contains 21 self-report items, completed using a multiple-choice format. Scores range from 0-63 with higher scores associated with more severe depression.

5-Dimensional Altered States of Consciousness Questionnaire
The 5D-ASC scale measures altered states of consciousness and contains 94 items (visual analog scales).

Data attribution

A large set of the trials in our database are sourced from ClinicalTrials.gov (CTG). We have modified these post to display the information in a more clear format or to correct spelling mistakes. Our database in actively updated and may show a different status (e.g. completed) if we have knowledge of this update (e.g. a published paper on the study) which isn't reflected yet on CTG. If a trial is not sourced from CTG, this is indicated on this page and you can follow the link to the alternative source of information.