The primary goal of this pilot study is to investigate whether psilocybin alters neuroplasticity in people with major depressive disorder. The primary hypothesis is that psilocybin will result in neuroplastic changes that parallel improvement in symptoms of depression.
Topic Depression
Compound Placebo
Psilocybin
Country United States of America
Visit trial
Status
Completed
Results Published
No
Start date
30 June 2018
End date
04 January 2023
Chance of happening
100%
Phase
Phase I
Design
Blinded
Type
Interventional
Generation
First
Participants
18
Sex
All
Age
18- 65
Therapy
No
Trial Details
In this placebo-controlled, blinded study, individuals with depression will participate in 2 experimental sessions approximately 4 weeks apart during which they will receive two of the following three interventions: 1) placebo, 2) low dose psilocybin (0.1 mg/kg), and 3) medium dose psilocybin (0.3 mg/kg).NCT Number NCT03554174
Sponsors & Collaborators
Yale UniversityThe Yale Psychedelic Science Group was established in 2016.
Heffter Research Institute
The Heffter Research Institute has been advancing psychedelics (psilocybin) as medicines since 1993.
Papers
Sub-acute effects of psilocybin on EEG correlates of neural plasticity in major depression: Relationship to symptomsThis double-blind, placebo-controlled, within-subject study (n=19) involved individuals with major depressive disorder (MDD). It investigated the effects of a single dose of psilocybin on electroencephalographic (EEG) correlates of neuroplasticity and depression symptoms. The results showed that EEG theta power doubled in amplitude two weeks after psilocybin administration. This increase was correlated with improvements in depression symptoms, suggesting that psilocybin may produce sustained changes in brain neuroplasticity and have antidepressant effects. Note that the improvement in depression scores was not significant vs placebo.
Psilocybin-assisted therapy for major depressive disorder: An exploratory placebo-controlled, fixed-order trial
This single-blind, placebo-controlled study (n=19) of psilocybin (21mg/70kg) in combination with therapy (ACT, 8x) finds an improvement in depression scores. However, the difference between the psilocybin and placebo groups was insignificant. Though the study tried to control for expectancy (placebo) effects, participants (80%) correctly guessed if they received psilocybin.
Measures Used
Hamilton Depression Rating ScaleThe Hamilton Depression Rating Scale (HDRS) is a multiple item questionnaire used to provide an indication of depression, and as a guide to evaluating recovery. The scale consists of 17 items which each item being scoring on a 3 or 5 point scale. The higher the score, the more likely a person is depressed.
Quick Inventory of Depressive Symptomatology
The Quick Inventory of Depressive Symptomatology (Self-Report) (QIDS-SR16) is a self-report tool designed to screen for depression and measure changes in the severity of symptoms.