Psilocybin - Induced Neuroplasticity in the Treatment of Major Depressive Disorder

Yale University

Status and phase: Active, not recruiting; Phase 1

Conditions: Major Depressive Disorder

Treatments: Drug: Medium Dose Psilocybin; Drug: Low Dose Psilocybin; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03554174

2000022394

Details and patient eligibility

About

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.

Full 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).

Enrollment: 18 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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18 participants in 4 patient groups

Placebo/Low Dose Psilocybin

Experimental group

Description:

Subjects in this arm receive placebo in the first session and low dose psilocybin in the second session.

Treatment:

Drug: Placebo

Drug: Low Dose Psilocybin

Placebo/Medium Dose Psilocybin

Experimental group

Description:

Subjects in this arm receive placebo in the first session and medium dose psilocybin in the second session.

Treatment:

Drug: Placebo

Drug: Medium Dose Psilocybin

Low Dose Psilocybin/Placebo

Experimental group

Description:

Subjects in this arm receive low dose psilocybin in the first session and placebo in the second session.

Treatment:

Drug: Placebo

Drug: Low Dose Psilocybin

Medium Dose Psilocybin/Placebo

Experimental group

Description:

Subjects in this arm receive medium dose psilocybin in the first session and placebo in the second session.

Treatment:

Drug: Placebo

Drug: Medium Dose Psilocybin