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

• Status: Recruiting
• Trial end date: 2022-03-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Franz Xaver Vollenweider; University of Zurich
• Collaborator: Schweizerischer Nationalfonds
• Treatments: Psilocybin

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