Active, Not RecruitingPhase 1psilocybin

Psilocybin - Induced Neuroplasticity in the Treatment of Major Depressive Disorder

NCT ID

NCT03554174

Target Enrollment

18 participants

Start Date

2018-02-27

Est. Completion

2026-09

About This Study

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.

Conditions Studied

Major Depressive Disorder

Interventions

•Low Dose Psilocybin
•Placebo
•Medium Dose Psilocybin

Eligibility

Age:18 Years - 65 Years

Healthy Volunteers:No

View full 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

Study Locations (1)

VA Connecticut Healthcare System, West Haven Campus