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Effects of Psilocybin in Major Depressive Disorder

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ClinicalTrials.gov Identifier: NCT03181529
Recruitment Status : Completed
First Posted : June 8, 2017
Last Update Posted : December 11, 2020
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

Tracking Information
First Submitted Date  ICMJE June 7, 2017
First Posted Date  ICMJE June 8, 2017
Last Update Posted Date December 11, 2020
Actual Study Start Date  ICMJE August 10, 2017
Actual Primary Completion Date December 2, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 7, 2017)
GRID-HAMD [ Time Frame: 1 week after second psilocybin session ]
The GRID-Hamilton Depression Rating Scale is a 17-item clinician-administered rating scale designed to assess severity of depressive symptoms. The score range for the GRID-HAMD is 0 to 52, with higher score indicating more severe depression.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Psilocybin in Major Depressive Disorder
Official Title  ICMJE Effects of Psilocybin in Major Depressive Disorder
Brief Summary The proposed pilot study will assess whether people with major depressive disorder experience psychological and behavioral benefits and/or harms from psilocybin. This study will investigate acute and persisting effects of psilocybin on depressive symptoms and other moods, attitudes, and behaviors. The primary hypothesis is that psilocybin will lead to rapid and sustained antidepressant response, as measured with standard depression rating scales.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description:
Primary outcome measure (GRID-HAMD) will be assessed by raters blinded to randomization condition.
Primary Purpose: Treatment
Condition  ICMJE Major Depressive Disorder
Intervention  ICMJE Drug: Psilocybin
Participants will receive a moderately high psilocybin dose in the first session and will receive either a moderately high or high psilocybin dose in the second session.
Study Arms  ICMJE
  • Experimental: Immediate Treatment
    Participants will begin psilocybin intervention immediately after study enrollment.
    Intervention: Drug: Psilocybin
  • Experimental: Delayed Treatment
    Participants will begin the psilocybin intervention 8 weeks after study enrollment.
    Intervention: Drug: Psilocybin
Publications * Davis AK, Barrett FS, May DG, Cosimano MP, Sepeda ND, Johnson MW, Finan PH, Griffiths RR. Effects of Psilocybin-Assisted Therapy on Major Depressive Disorder: A Randomized Clinical Trial. JAMA Psychiatry. 2021 May 1;78(5):481-489. doi: 10.1001/jamapsychiatry.2020.3285. Erratum in: JAMA Psychiatry. 2021 Feb 10;:.

*   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 Completed
Actual Enrollment  ICMJE
 (submitted: June 7, 2017)
24
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2, 2020
Actual Primary Completion Date December 2, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 21 to 75 years old
  • Have given written informed consent
  • Have at least a high-school level of education or equivalent (e.g. GED).
  • Have a confirmed Diagnostic Statistical Manual (DSM-5) diagnosis of Major Depressive Disorder and currently experiencing a major depressive episode.
  • No antidepressant medication for at least 2 weeks (4 weeks for fluoxetine) prior to enrollment.
  • Concurrent psychotherapy is allowed if the type and frequency of the therapy has been stable for at least two months prior to screening and is expected to remain stable during participation in the study.
  • Be medically stable as determined by screening for medical problems via a personal interview, a medical questionnaire, a physical examination, an electrocardiogram (ECG), and routine medical blood and urinalysis laboratory tests
  • Agree to consume approximately the same amount of caffeine-containing beverage (e.g., coffee, tea) that he/she consumes on a usual morning, before arriving at the research unit on the mornings of drug session days. If the participant does not routinely consume caffeinated beverages, he/she must agree not to do so on session days.
  • Agree to refrain from using any psychoactive drugs, including alcoholic beverages and nicotine, within 24 hours of each drug administration. The exception is caffeine. Participants will be required to be non-smokers.
  • Agree not to take any Pro re nata (PRN) medications on the mornings of drug sessions
  • Agree not to take sildenafil (Viagra®), tadalafil, or similar medications within 72 hours of each drug administration.
  • Agree that for one week before each drug session, he/she will refrain from taking any nonprescription medication, nutritional supplement, or herbal supplement except when approved by the study investigators. Exceptions will be evaluated by the study investigators and will include acetaminophen, non-steroidal anti-inflammatory drugs, and common doses of vitamins and minerals.

Exclusion Criteria:

  • Women who are pregnant (as indicated by a positive urine pregnancy test assessed at intake and before each drug session) or nursing; women who are of child-bearing potential and sexually active who are not practicing an effective means of birth control.
  • Cardiovascular conditions: coronary artery disease, stroke, angina, uncontrolled hypertension, a clinically significant ECG abnormality (e.g., atrial fibrilation), prolonged QTc interval (i.e., QTc > 450 msec), artificial heart valve, or Transient Ischemic Attack (TIA) in the past year
  • Epilepsy with history of seizures
  • Insulin-dependent diabetes; if taking oral hypoglycemic agent, then no history of hypoglycemia
  • Currently taking psychoactive prescription medication on a regular (e.g., daily) basis
  • Currently taking on a regular (e.g., daily) basis any medications having a primary centrally-acting serotonergic effect, including Mono-Amine Oxidase Inhibitors (MAOIs). For individuals who have intermittent or PRN use of such medications, psilocybin sessions will not be conducted until at least 5 half-lives of the agent have elapsed after the last dose.
  • More than 25% outside the upper or lower range of ideal body weight according to Metropolitan Life height and weight table

Psychiatric Exclusion Criteria:

  • Current antidepressant use
  • Current or past history of meeting DSM-5 criteria for schizophrenia spectrum or other psychotic disorders (except substance/medication-induced or due to another medical condition), or Bipolar I or II Disorder
  • Current or history within one year of meeting DSM-5 criteria for a moderate or severe alcohol, tobacco, or other drug use disorder (excluding caffeine)
  • Have a first or second-degree relative with schizophrenia spectrum or other psychotic disorders (except substance/medication-induced or due to another medical condition), or Bipolar I or II Disorder
  • Has failed to respond to electroconvulsive therapy during the current major depressive episode
  • Has a psychiatric condition judged to be incompatible with establishment of rapport or safe exposure to psilocybin

Additional Magnetic Resonance Imaging (MRI) Exclusion Criteria:

  • Head trauma
  • Claustrophobia incompatible with scanning
  • Cardiac pacemaker
  • Implanted cardiac defibrillator
  • Aneurysm brain clip
  • Inner ear implant
  • Prior history as a metal worker and/or certain metallic objects in the body
  • History of clinically significant vertigo, seizure disorder, middle ear disorder, or double vision
  • Poor vision not adequately corrected (in order to complete emotional processing task)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 75 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 NCT03181529
Other Study ID Numbers  ICMJE IRB00101821
Has Data Monitoring Committee Yes
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 Johns Hopkins University
Study Sponsor  ICMJE Johns Hopkins University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Roland R Griffiths, PhD Johns Hopkins University
PRS Account Johns Hopkins University
Verification Date December 2020

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