ClinicalTrials.gov
ClinicalTrials.gov Menu

Clinical, Neurocognitive, and Emotional Effects of Psilocybin in Depressed Patients - Proof of Concept

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03715127
Recruitment Status : Not yet recruiting
First Posted : October 22, 2018
Last Update Posted : January 11, 2019
Sponsor:
Collaborator:
Schweizerischer Nationalfonds
Information provided by (Responsible Party):
University of Zurich

Brief Summary:
Effects of serotonin 2A/1A receptor stimulation by psilocybin on mood and emotion processing in major depressive disorder: a randomized double-blind placebo-controlled study

Condition or disease Intervention/treatment Phase
Depressive Disorder, Major Drug: Psilocybine oral capsule Drug: Placebo oral capsule Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: double-blind
Primary Purpose: Treatment
Official Title: Phase II, Randomized, Double Blind, Placebo Controlled, Parallel Group, Single Center Study of Psilocybin Efficacy in Major Depression
Estimated Study Start Date : March 2019
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : October 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo
one oral dose of 100% mannitol (placebo)
Drug: Placebo oral capsule
single dose of placebo (100% mannitol)

Active Comparator: Psilocybin
one oral dose of 0.215mg/kg psilocybin (verum)
Drug: Psilocybine oral capsule
single dose of psilocybin (0.215mg / kg body weight)




Primary Outcome Measures :
  1. Montgomery Asberg Depression Scale [ Time Frame: Day 32 ]
    observer-rated score for depression

  2. Beck Depression Inventory [ Time Frame: Day 32 ]
    self-rated score for depression


Secondary Outcome Measures :
  1. Changes in BOLD signal over time as measured by fMRI [ Time Frame: Day 17, 20, 32 ]
    3 times assessement of fMRI

  2. 5 Dimensions- Altered States of consciousness(5D-ASC) [ Time Frame: Day 18 ]
    Assessment of subjective alterations in state of conciousness



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Capable of giving informed consent
  • Informed consent as documented by signature
  • Male and female in- and outpatients 18 years to 60 years of age
  • Right-handedness
  • DSM-IV-diagnosis of mild or moderate major depressive episode without psychotic features (based on clinical assessment and confirmed by the SCID Interview)
  • Score of ≥ 10 and ≤40 on the Montgomery-Asberg Depression Rating Scale (MADRS) at both screening and baseline visits.
  • Drug free from any psychotropic medication for at least two weeks (or five weeks for fluoxetine) before enrolling in the study
  • Judged clinically not to be a serious suicide risk
  • Good physical health with no unstable medical conditions, as determined by medical history, physical examination, routine blood labs, electrocardiogram, urineanalysis, and urine toxicology
  • Normal level of language comprehension and German or Swiss-German as first language
  • Willing to refrain from drinking alcohol the day before testing days, from drinking alcohol and caffeinated drinks during the testing days and from consuming psychoactive substances 2 weeks before enrolling in the study and for the remainder of the study
  • Women of childbearing potential must be using an effective, established method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices. Note: female participants who are surgically sterilised / hysterectomised or post-menopausal for longer than 2 years are not considered as being of child bearing potential.
  • Have a family member or friend who can pick them up and stay with them overnight after the psilocybin administration sessions (driving is forbidden at drug treatment days)

Exclusion Criteria:

  • Lifetime history of bipolar disorder (I, II, not otherwise specified)
  • Lifetime history of schizophrenia, schizoaffective disorder, or psychosis not otherwise specified
  • History of DSM-IV drug or alcohol dependence or abuse (except for caffeine or nicotine) within three months prior to enrollment
  • Comorbid Axis I anxiety disorder diagnoses will be permitted if they do not require current treatment
  • Family history of schizophrenia or schizoaffective disorder, or bipolar disorder type 1 (first or second degree relatives)
  • Lifetime history of hallucinogen use on more than 10 occasions
  • Getting psychotherapeutic or psychological treatment from third parties during the study is forbidden
  • Abnormal electrocardiogram
  • Any unstable illness as determined by history or laboratory tests
  • BMI <17 or >35
  • Uncorrected hypo- or hyperthyroidism
  • Women who are pregnant or breast feeding, or have the intention to become pregnant during the course of the study
  • Contraindications to magnetic resonance imaging (MRI safety form)
  • During the study, new use or dose changes of already existing concomitant medication without prior informing the investigators is forbidden
  • Allergy, hypersensitivity, or other adverse reaction to previous use of psilocybin or other hallucinogens
  • High risk of adverse emotional or behavioral reaction based on investigator's clinical evaluation (e.g., evidence of serious personality disorder, antisocial behavior, serious current stressors, lack of meaningful social support)
  • Participation in another study with investigational drug within the 30 days preceding and during the present study

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): NCT03715127


Contacts
Contact: Franz X Vollenweider, Prof.Dr.,MD +41 44 384 26 04 vollen@bli.uzh.ch
Contact: Robin Y von Rotz, MSc, PhD cand. +41 44 384 26 16 robin.vonrotz@bli.uzh.ch

Sponsors and Collaborators
University of Zurich
Schweizerischer Nationalfonds

Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT03715127     History of Changes
Other Study ID Numbers: PSIDEPR128
First Posted: October 22, 2018    Key Record Dates
Last Update Posted: January 11, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by University of Zurich:
Depression
5HT-2A
Psilocybin
clinical efficacy
self
emotion regulation
placebo-controlled
proof-of-concept

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