Clinical trial NCT03554174: Psilocybin - Induced Neuroplasticity in the Treatment of Major Depressive Disorder
Official title: Psilocybin - Induced Neuroplasticity in the Treatment of Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Major Depressive Disorder
Keywords: psilocybin
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: Heffter Research Institute
First posted: 2018-06-13
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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).

Eligibility criteria: 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

Primary outcomes:
measure: Changes in electrical brain activity associated with neuroplasticity measured by Electroencephalography (EEG)
timeFrame: One day and two weeks after each experimental session
Secondary outcomes:
measure: Changes in verbal memory [ Time Frame: One day and two weeks after each experimental session ]
timeFrame: One day and two weeks after each experimental session
measure: Change in mood symptoms using the GRID-Hamilton Depression Rating Scale (GRID-HAM-D)
timeFrame: Four weeks before the initiation of testing, the day before and after each experimental session, and one and two weeks after each experimental session.
measure: Change in mood symptoms using the Quick Inventory of Depressive Symptoms (QIDS-SR16)
timeFrame: 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.
Other outcomes:
Locations:
city: West Haven
country: United States
facility: VA Connecticut Healthcare System, West Haven Campus
state: Connecticut
Study officials:
affiliation: Yale University
name: Deepak D'Souza, MD
role: PRINCIPAL_INVESTIGATOR
References: