The Safety and Efficacy of Psilocybin in Participants With Type 2 Bipolar Disorder (BP-II) Depression.

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.

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 System
This 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 Episodes
This 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 Scale
A ten-item diagnostic questionnaire used to measure the severity of depressive symptoms in patients with mood disorders.

Data attribution

A large set of the trials in our database are sourced from ClinicalTrials.gov (CTG). We have modified these post to display the information in a more clear format or to correct spelling mistakes. Our database in actively updated and may show a different status (e.g. completed) if we have knowledge of this update (e.g. a published paper on the study) which isn't reflected yet on CTG. If a trial is not sourced from CTG, this is indicated on this page and you can follow the link to the alternative source of information.