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

Topic Depression
Compound Placebo Psilocybin
Country Switzerland
Visit trial
Status Completed
Results Published Yes
Start date 11 March 2019
End date 12 April 2022
Phase Phase II
Design Blinded
Type Interventional
Generation First
Participants 60
Sex All
Age 18- 60
Therapy No

Trial Details



Trial 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).

A review of psychedelics trials completed in depression, informed by European regulatory perspectives
This systematic review (s=8) analyses completed controlled trials of psychedelics for depression, including psilocybin, LSD, ayahuasca, and DMT, all in Phase II or I/II. It evaluates methodological patterns against the draft European Medicines Agency guideline revision, highlighting challenges such as unblinding, expectancy, and adverse event characterisation, while calling for larger studies to assess long-term efficacy and safety.

Psilocybin increases emotional empathy in patients with major depression
This re-analysis of an RCT (n=51) investigates the effects of psilocybin-assisted therapy on empathy in depressed patients. Participants received either a single psilocybin dose (15mg/70kg) or placebo within a 4-week psychological support programme. Psilocybin significantly improved emotional empathy, particularly towards positive stimuli, for up to two weeks compared to placebo.

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

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