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Psilocybin - Induced Neuroplasticity in the Treatment of Major Depressive Disorder

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ClinicalTrials.gov Identifier: NCT03554174
Recruitment Status : Recruiting
First Posted : June 13, 2018
Last Update Posted : April 18, 2019
Sponsor:
Collaborator:
Heffter Research Institute
Information provided by (Responsible Party):
Deepak C. D'Souza, Yale University

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.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Drug: Low Dose Psilocybin Drug: Placebo Drug: Medium Dose Psilocybin Phase 1

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Psilocybin - Induced Neuroplasticity in the Treatment of Major Depressive Disorder
Actual Study Start Date : June 30, 2018
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : April 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Placebo/Low Dose Psilocybin
Subjects in this arm receive placebo in the first session and low dose psilocybin in the second session.
Drug: Low Dose Psilocybin
0.1 mg/kg psilocybin capsule

Drug: Placebo
microcrystalline cellulose capsule

Experimental: Placebo/Medium Dose Psilocybin
Subjects in this arm receive placebo in the first session and medium dose psilocybin in the second session.
Drug: Placebo
microcrystalline cellulose capsule

Drug: Medium Dose Psilocybin
0.3 mg/kg psilocybin capsule

Experimental: Low Dose Psilocybin/Placebo
Subjects in this arm receive low dose psilocybin in the first session and placebo in the second session.
Drug: Low Dose Psilocybin
0.1 mg/kg psilocybin capsule

Drug: Placebo
microcrystalline cellulose capsule

Experimental: Medium Dose Psilocybin/Placebo
Subjects in this arm receive medium dose psilocybin in the first session and placebo in the second session.
Drug: Placebo
microcrystalline cellulose capsule

Drug: Medium Dose Psilocybin
0.3 mg/kg psilocybin capsule




Primary Outcome Measures :
  1. Changes in electrical brain activity associated with neuroplasticity measured by Electroencephalography (EEG) [ Time Frame: One day and two weeks after each experimental session ]
    An auditory Long Term Potentiation (LTP) task will assess changes in neuronal plasticity. For the EEG task, the outcome measures will include event-related potential (ERP) amplitude and latency, and time x frequency measures (i.e. spectral power, inter-trial coherence, and cross-frequency coupling).


Secondary Outcome Measures :
  1. 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.

  2. Changes in electrical brain activity associated with emotion processing [ Time Frame: One day and two weeks after each experimental session ]
    This will be measured by an affective go/no task and electroencephalography. Outcome measures will include event-related potential (ERP) amplitude and latency, and time x frequency measures (i.e. spectral power, inter-trial coherence, and cross-frequency coupling).

  3. Change in mood symptoms using the GRID-Hamilton Depression Rating Scale (GRID-HAM-D) [ 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. ]
    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.

  4. Change in mood symptoms using the Quick Inventory of Depressive Symptoms (QIDS-SR16) [ 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. ]
    The QIDS-SR16 is a 16-item self-reported rating scale designed to assess severity of depressive symptoms.

  5. Change in blood pressure [ Time Frame: Measured during each test session prior to drug administration, every 30 min for the first two and then hourly for 4 hours or until resolution of psychedelic effects (~6 hours post drug) ]
    Maximum change from baseline during each test day (mmHg)

  6. Change in heart rate [ Time Frame: Measured during each test session prior to drug administration, every 30 min for the first two and then hourly for 4 hours or until resolution of psychedelic effects (~6 hours post drug) ]
    Maximum change from baseline during each test day (beats per minute)

  7. Change in peripheral oxygenation [ Time Frame: Measured during each test session prior to drug administration, every 30 min for the first two and then hourly for 4 hours or until resolution of psychedelic effects (~6 hours post drug) ]
    Maximum change from baseline during each test day (SpO2)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03554174


Contacts
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Contact: Leigh T Flynn, BS (203) 932-5711 ext 2526 leigh.flynn@yale.edu
Contact: Jordan Sloshower, MD (203) 932-5711 ext 2526 jordan.sloshower@yale.edu

Locations
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United States, Connecticut
VA Connecticut Healthcare System, West Haven Campus Recruiting
West Haven, Connecticut, United States, 06516
Contact: Leigh T Flynn, BS    203-932-5711 ext 2526    leigh.flynn@yale.edu   
Contact: Jordan Sloshower, MD    (203) 932-5711 ext 2526    jordan.sloshower@yale.edu   
Principal Investigator: Deepak Cyril D'Souza, MD         
Sponsors and Collaborators
Yale University
Heffter Research Institute

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Responsible Party: Deepak C. D'Souza, Professor of Psychiatry, Yale University
ClinicalTrials.gov Identifier: NCT03554174     History of Changes
Other Study ID Numbers: 2000022394
First Posted: June 13, 2018    Key Record Dates
Last Update Posted: April 18, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Deepak C. D'Souza, Yale University:
psilocybin

Additional relevant MeSH terms:
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Disease
Depressive Disorder
Depression
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms
Psilocybin
Hallucinogens
Physiological Effects of Drugs
Psychotropic Drugs