Clinical TrialMajor Depressive Disorder (MDD)PsilocybinWithdrawn

PET Synaptogenesis After Psilocybin In Depression Recovery (PET-SPIDER)

This neuroimaging trial (n=24) investigates the effects of one high dose of psilocybin (25mg) in those with depression. It specifically investigates the synaptic density (synapses are the connections between brain cells; neurons). The aim is to assess the relationship between the antidepressant and neurotrophic (growth within brain) effects of psilocybin.

Target Enrollment
24 participants
Study Type
Phase II interventional
Design
Non-randomized

Detailed Description

Open-label treatment study in adults with major depressive disorder and anhedonia receiving a single 25 mg oral dose of psilocybin with supportive psychotherapy; PET imaging with 11C-UCB-J performed at baseline and one week post-dose to assess synaptic density.

The primary aim is to relate psilocybin-induced neurotrophic changes (SV2A binding) to antidepressant response; procedures include psychological support before, during and after dosing and multimodal imaging.

Study Protocol

Preparation

sessions

Dosing

1 sessions

Integration

sessions

Therapeutic Protocol

support

Study Arms & Interventions

Psilocybin

experimental

Single 25 mg oral psilocybin with supportive psychotherapy

Interventions

  • Psilocybin25 mg
    via Oral• single dose• 1 doses total

    25 mg oral tablet plus supportive psychotherapy

Participants

Ages
18 – 65
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • 1. Men and women between 18 and 65 years of age;
  • 2. Able to provide informed consent
  • 3. Women of childbearing age must agree to be on two forms of contraception and men are required to utilize at least one form of contraception
  • 4. Willingness to comply and be available for all study requirements, including psychological, cognitive, and imaging for the duration of the study
  • 5. Meeting DSM-5 criteria for major depressive disorder and current depressive episode
  • 6. Snaith-Hamilton Anhedonia Pleasure Scale (SHAPS) ≥ 6 points
  • 7. Willing and able to taper and/or discontinue current psychotropic medications

Exclusion Criteria

  • Exclusion Criteria:
  • 1. Women who are pregnant or who intend to become pregnant or nurse during the study duration.
  • 2. Presence of psychiatric conditions that are contraindications to psilocybin exposure (e.g., personal or first degree relative with history of schizophrenia spectrum or bipolar disorder);
  • 3. Use of psychotropic medication that may interact with psilocybin (TCA, MAOi, antipsychotic/neuroleptics, anti-epileptic/mood stabilizer, lithium, SSRI, SNRI, Mirtazapine, Buproprion, Vortioxetine).
  • 4. Recent use of psychedelics (psilocybin, LSD, ayahuasca, mescaline; past 5 years); or prior severe adverse reactions to psychedelics
  • 5. Active suicidal ideation or history of a suicide attempt.
  • 6. Presence of medical conditions that are contraindications to psilocybin exposure (e.g., neurological conditions or severe hypertension, severe and/or unstable metabolic or cardiovascular conditions);
  • 7. Current medical conditions that are known to increase risk of severe coronavirus infection or deemed by a study physician to put an individual at high risk (i.e., cancer, COPD, obesity, immunosuppression, type 2 diabetes, serious heart conditions, sickle cell disease, asthma);
  • 8. Presence of contraindications to PET or MRI scanning (renal disease, implantable devices, bone hardware, some IUDs);
  • 9. Body mass index >30 (due to MRI confounds).

Study Details

Locations

Washington University School of Medicine — St Louis, Missouri, United States

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