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.
Topic Depression
Compound Placebo
Psilocybin
Country Sweden
Visit trial
Status
Not yet recruiting
Results Published
Start date
01 January 2021
End date
12 January 2022
Chance of happening
44%
Phase
Phase II
Design
Blinded
Type
Interventional
Generation
First
Participants
30
Sex
All
Age
18- 99
Therapy
No
Trial Details
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 Labelling: Study Intervention will be provided in a high-density polyethylene (HDPE) bottle. Each bottle will contain one capsule (psilocybin or niacin) and will be labelled as required per Swedish requirement for blinded study.NCT Number NCT04630964
Sponsors & Collaborators
Karolinska InstitutetKI is Sweden’s single largest centre of medical academic research which as expanded into the field of psychdelics.
Section for Affective Disorders
This company doesn't have a full profile yet, it is linked to a clinical trial.
Measures Used
Montgomery-Asberg Depression Rating ScaleA ten-item diagnostic questionnaire used to measure the severity of depressive symptoms in patients with mood disorders.