Psilocybin - Induced Neuroplasticity in the Treatment of Major Depressive Disorder

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-27

Study Completion Date

2026-09-30

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Major Depressive Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Placebo/Low Dose Psilocybin

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

Group Type EXPERIMENTAL

Low Dose Psilocybin

Intervention Type DRUG

0.1 mg/kg psilocybin capsule

Placebo

Intervention Type DRUG

microcrystalline cellulose capsule

Placebo/Medium Dose Psilocybin

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

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

microcrystalline cellulose capsule

Medium Dose Psilocybin

Intervention Type DRUG

0.3 mg/kg psilocybin capsule

Low Dose Psilocybin/Placebo

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

Group Type EXPERIMENTAL

Low Dose Psilocybin

Intervention Type DRUG

0.1 mg/kg psilocybin capsule

Placebo

Intervention Type DRUG

microcrystalline cellulose capsule

Medium Dose Psilocybin/Placebo

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

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

microcrystalline cellulose capsule

Medium Dose Psilocybin

Intervention Type DRUG

0.3 mg/kg psilocybin capsule

Interventions

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Low Dose Psilocybin

0.1 mg/kg psilocybin capsule

Intervention Type DRUG

Placebo

microcrystalline cellulose capsule

Intervention Type DRUG

Medium Dose Psilocybin

0.3 mg/kg psilocybin capsule

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No