Psilocybin - Induced Neuroplasticity in the Treatment of Major Depressive Disorder

Phase 1Active Not RecruitingNCT03554174

Yale University18 enrolled

Overview

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.

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Major Depressive Disorder

Interventions

Low Dose PsilocybinDRUG

0.1 mg/kg psilocybin capsule

PlaceboDRUG

microcrystalline cellulose capsule

Medium Dose PsilocybinDRUG

0.3 mg/kg psilocybin capsule

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Diagnosed with Major Depressive Disorder (MDD), single or recurrent episode, and currently experiencing a Major Depressive Episode (MDE) * Failed to achieve a satisfactory clinical response to at least one adequate antidepressant trial during the current depressive episode * Currently engaged in treatment with a mental health clinician Exclusion Criteria: * Axis I psychotic disorder (e.g. schizophrenia, bipolar I, depression with psychosis) * Axis I psychotic disorder in first degree relative * Currently taking a conventional antidepressant medication * Unstable medical or neurological conditions * Significant cognitive disorders * History of intolerance to drugs known to significantly alter perception e.g., psilocybin, LSD, salvinorin A, mescaline, etc. * Pregnant, breastfeeding, lack of adequate birth control * Urine toxicology positive to drugs of abuse on experimental test days

Locations (1)

VA Connecticut Healthcare System, West Haven Campus

West Haven, Connecticut, United States

Outcomes

Primary Outcomes

Changes in electrical brain activity associated with neuroplasticity measured by Electroencephalography (EEG)

An auditory Long Term Potentiation (LTP) task will assess changes in neuroplasticity. For the EEG task, the outcome measures will include stimulus-evoked time x frequency analysis (e.g., spectral power)

Time frame: One day and two weeks after each experimental session

Secondary Outcomes

Changes in verbal memory [ Time Frame: One day and two weeks after each experimental session ]

This will be measured by a modified computer version of the Rey Auditory Verbal Learning Test (RAVLT), administered while EEG data is collected. The EEG outcomes will include time x frequency analysis (e.g., spectral power) during the learning and recognition phases of the task.

Time frame: One day and two weeks after each experimental session

Change in mood symptoms using the GRID-Hamilton Depression Rating Scale (GRID-HAM-D)

The GRID-Hamilton Depression Rating Scale is a clinician-administered rating scale designed to assess severity of depressive symptoms. It includes 17 items, nine of which are scored on 5-point scale, and eight of which are scored on a three-point scale. The score range for the GRID-HAMD is 0 to 52, with higher score indicating more severe depression.

Time frame: Four weeks before the initiation of testing, the day before and after each experimental session, and one and two weeks after each experimental session.

Change in mood symptoms using the Quick Inventory of Depressive Symptoms (QIDS-SR16)

The QIDS-SR16 is a 16-item self-reported rating scale designed to assess severity of depressive symptoms.

Time frame: Four weeks before the initiation of testing, the day before and after each experimental session, one and two weeks after each experimental session, then monthly for three months after the last experimental session.

Data from ClinicalTrials.gov

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