Psilocybin - Induced Neuroplasticity in the Treatment of Major Depressive Disorder

Major Depressive Disorder Clinical Trial

Official title:

Psilocybin - Induced Neuroplasticity in the Treatment of Major Depressive Disorder

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03554174
• Other study ID #: 2000022394
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: February 27, 2018
• Est. completion date: April 2025

Study information

• Verified date: May 2024
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 18
• Est. completion date: April 2025
• Est. primary completion date: July 8, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Drug:
• Low Dose Psilocybin
0.1 mg/kg psilocybin capsule
• Placebo
microcrystalline cellulose capsule
• Medium Dose Psilocybin
0.3 mg/kg psilocybin capsule

Locations

Country	Name	City	State
United States	VA Connecticut Healthcare System, West Haven Campus	West Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	Heffter Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	One day and two weeks after each experimental session
Secondary	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.	One day and two weeks after each experimental session
Secondary	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.	Four weeks before the initiation of testing, the day before and after each experimental session, and one and two weeks after each experimental session.
Secondary	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.	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.