search
Back to results

Psilocybin - Induced Neuroplasticity in the Treatment of Major Depressive Disorder

Primary Purpose

Major Depressive Disorder

Status
Active
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Low Dose Psilocybin
Placebo
Medium Dose Psilocybin
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring psilocybin

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • VA Connecticut Healthcare System, West Haven Campus

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Placebo/Low Dose Psilocybin

Placebo/Medium Dose Psilocybin

Low Dose Psilocybin/Placebo

Medium Dose Psilocybin/Placebo

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
April 13, 2018
Last Updated
June 5, 2023
Sponsor
Yale University
Collaborators
Heffter Research Institute
search

1. Study Identification

Unique Protocol Identification Number
NCT03554174
Brief Title
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

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 27, 2018 (Actual)
Primary Completion Date
February 27, 2024 (Anticipated)
Study Completion Date
April 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yale University
Collaborators
Heffter Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
psilocybin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
18 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Placebo/Low Dose Psilocybin
Arm Type
Experimental
Arm Description
Subjects in this arm receive placebo in the first session and low dose psilocybin in the second session.
Arm Title
Placebo/Medium Dose Psilocybin
Arm Type
Experimental
Arm Description
Subjects in this arm receive placebo in the first session and medium dose psilocybin in the second session.
Arm Title
Low Dose Psilocybin/Placebo
Arm Type
Experimental
Arm Description
Subjects in this arm receive low dose psilocybin in the first session and placebo in the second session.
Arm Title
Medium Dose Psilocybin/Placebo
Arm Type
Experimental
Arm Description
Subjects in this arm receive medium dose psilocybin in the first session and placebo in the second session.
Intervention Type
Drug
Intervention Name(s)
Low Dose Psilocybin
Intervention Description
0.1 mg/kg psilocybin capsule
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
microcrystalline cellulose capsule
Intervention Type
Drug
Intervention Name(s)
Medium Dose Psilocybin
Intervention Description
0.3 mg/kg psilocybin capsule
Primary Outcome Measure Information:
Title
Changes in electrical brain activity associated with neuroplasticity measured by Electroencephalography (EEG)
Description
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 Outcome Measure Information:
Title
Changes in verbal memory [ Time Frame: One day and two weeks after each experimental session ]
Description
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
Title
Change in mood symptoms using the GRID-Hamilton Depression Rating Scale (GRID-HAM-D)
Description
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.
Title
Change in mood symptoms using the Quick Inventory of Depressive Symptoms (QIDS-SR16)
Description
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
VA Connecticut Healthcare System, West Haven Campus
City
West Haven
State/Province
Connecticut
ZIP/Postal Code
06516
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Psilocybin - Induced Neuroplasticity in the Treatment of Major Depressive Disorder

We'll reach out to this number within 24 hrs