The Effect of Psilocybin on MDD Symptom Severity and Synaptic Density
Status:
Recruiting
Trial end date:
2022-12-01
Target enrollment:
Participant gender:
Summary
PROTOCOL SYNOPSIS Title The effect of psilocybin on Major depressive disorder (MDD) symptom
severity and synaptic density - a single dose randomized, double blind, placebo-controlled
phase 2b positron emission tomography study Study Code PSIPET Name of Sponsor SLSO
Organisationsnr: 232100-0016 Sponsor representative: Andreas Carlborg Norra Stockholms
Psykiatri Vårdvägen 3 112 19 Stockholm Sweden Medical Monitor Inspira Medical AB Phase of
Study Phase 2b Sample Size 30 randomized Name of Investigational Product (IP) Psilocybin,
3-[2-(dimethylamino)ethyl]-1H-indol-4-yl] dihydrogen phosphate Name of Active Placebo Niacin
EudraCT 2020-002790-94 Description of IP and Active Placebo PSIPET Protocol 5 200821 Page 14
Study Intervention Name: Psilocybin (active drug product) Niacin (active placebo product)
Dosage formulation: One active capsule contains 25 mg of psilocybin One active placebo
capsule contains 100 mg of niacin Capsule: Size 2 hydroxypropyl methylcellulose (HPMC),
opaque Size 2 HPMC, opaque Unit dose strength: 25 mg 100 mg Route of Administration: Oral
(solid dose) Oral (solid dose) Dosing instructions: One capsule administered with water One
capsule administered with water Packaging and Labeling: Study Intervention will be provided
in a high-density polyethylene (HDPE) bottle. Each bottle will contain one capsule
(psilocybin or niacin) and will be labeled as required per Swedish requirement for blinded
study.
Phase:
Phase 2
Details
Lead Sponsor:
Section for Affective Disorders; Northern Stockholm Psychiatry