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Psilocybin - Induced Neuroplasticity in the Treatment of Major Depressive Disorder

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ClinicalTrials.gov Identifier: NCT03554174
Recruitment Status : Active, not recruiting
First Posted : June 13, 2018
Last Update Posted : November 12, 2021
Sponsor:
Collaborator:
Heffter Research Institute
Information provided by (Responsible Party):
Deepak C. D'Souza, Yale University

Tracking Information
First Submitted Date  ICMJE April 13, 2018
First Posted Date  ICMJE June 13, 2018
Last Update Posted Date November 12, 2021
Actual Study Start Date  ICMJE June 30, 2018
Estimated Primary Completion Date June 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 5, 2018)
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).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 5, 2018)
  • 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.
  • 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).
  • 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.
  • 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.
  • 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)
  • 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)
  • 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)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Psilocybin - Induced Neuroplasticity in the Treatment of Major Depressive Disorder
Official Title  ICMJE Psilocybin - Induced Neuroplasticity in the Treatment of Major Depressive Disorder
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).
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Condition  ICMJE Major Depressive Disorder
Intervention  ICMJE
  • Drug: Low Dose Psilocybin
    0.1 mg/kg psilocybin capsule
  • Drug: Placebo
    microcrystalline cellulose capsule
  • Drug: Medium Dose Psilocybin
    0.3 mg/kg psilocybin capsule
Study Arms  ICMJE
  • Experimental: Placebo/Low Dose Psilocybin
    Subjects in this arm receive placebo in the first session and low dose psilocybin in the second session.
    Interventions:
    • Drug: Low Dose Psilocybin
    • Drug: Placebo
  • Experimental: Placebo/Medium Dose Psilocybin
    Subjects in this arm receive placebo in the first session and medium dose psilocybin in the second session.
    Interventions:
    • Drug: Placebo
    • Drug: Medium Dose Psilocybin
  • Experimental: Low Dose Psilocybin/Placebo
    Subjects in this arm receive low dose psilocybin in the first session and placebo in the second session.
    Interventions:
    • Drug: Low Dose Psilocybin
    • Drug: Placebo
  • Experimental: Medium Dose Psilocybin/Placebo
    Subjects in this arm receive medium dose psilocybin in the first session and placebo in the second session.
    Interventions:
    • Drug: Placebo
    • Drug: Medium Dose Psilocybin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: June 5, 2018)
18
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2023
Estimated Primary Completion Date June 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03554174
Other Study ID Numbers  ICMJE 2000022394
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Deepak C. D'Souza, Yale University
Study Sponsor  ICMJE Yale University
Collaborators  ICMJE Heffter Research Institute
Investigators  ICMJE Not Provided
PRS Account Yale University
Verification Date November 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP