The primary objective of this study is to evaluate the efficacy of 25 mg of psilocybin under supportive conditions to adult participants with BP-II, current episode depressed, in improving depressive symptoms.
Topic Bipolar Disorder
Depression
Compound Psilocybin
Country United States of America
Visit trial
Status
Recruiting
Results Published
No
Start date
03 January 2021
End date
31 August 2022
Chance of happening
100%
Phase
Phase II
Design
Open
Type
Interventional
Generation
First
Participants
12
Sex
All
Age
18- 65
Therapy
Yes
Trial Details
The primary objective of this study is to evaluate the efficacy of 25 mg of psilocybin under supportive conditions to adult participants with BP-II, current episode depressed, in improving depressive symptoms.NCT Number NCT04433845
Sponsors & Collaborators
Sheppard Pratt Health SystemThis company doesn't have a full profile yet, it is linked to a clinical trial.
COMPASS Pathways
COMPASS Pathways is a publicly listed company (NASDAQ) that is developing psilocybin for treatment-resistant depression (TRD) for which it has completed a successful Phase IIb trial. COMPASS is one of the largest psychedelic companies and has received substantial investment from atai.
Papers
Single-Dose Synthetic Psilocybin With Psychotherapy for Treatment-Resistant Bipolar Type II Major Depressive EpisodesThis open-label trial (n=15) investigated the safety and efficacy of a single dose of synthetic psilocybin (25 mg) in patients with Bipolar II disorder (BDII) experiencing a current depressive episode. The study found significant improvements in depression (MADRS) scores at three weeks posttreatment, with 12 participants meeting the response criterion and 11 achieving remission. The results suggest the potential efficacy and safety of psilocybin with psychotherapy in treating BDII.
Measures Used
Montgomery-Asberg Depression Rating ScaleA ten-item diagnostic questionnaire used to measure the severity of depressive symptoms in patients with mood disorders.