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

• ClinicalTrials.gov Identifier: NCT04433845
• Recruitment Status: Not yet recruiting
• First Posted: June 16, 2020
• Last Update Posted: October 12, 2020
• Sponsor: Sheppard Pratt Health System
• Collaborator: COMPASS Pathways
• Information provided by (Responsible Party): Scott T. Aaronson, M.D, Sheppard Pratt Health System

Tracking Information

• First Submitted Date: June 13, 2020
• First Posted Date: June 16, 2020
• Last Update Posted Date: October 12, 2020
• Estimated Study Start Date: November 1, 2020
• Estimated Primary Completion Date: January 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 13, 2020)

Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: From Baseline (Day -1) to three weeks post-dose. ]

MADRS is a clinician-rated scale measuring depression severity, consisting of 10 items, each scored from 0 (normal) to 6 (severe), for a total possible score of 60; higher scores denote greater severity. Response = >50% decrease and Remission =< 10 actual score

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: The Safety and Efficacy of Psilocybin in Participants With Type 2 Bipolar Disorder (BP-II) Depression.
• Official Title: The Safety and Efficacy of Psilocybin in Participants With Type 2 Bipolar Disorder (BP-II) Depression.
• Brief Summary: 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Treatment Resistant Depression

Intervention

Drug: Psilocybin

Open-label

Study Arms

Experimental: Psilocybin

25mg of Psilocybin

Intervention: Drug: Psilocybin

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Not yet recruiting
• Estimated Enrollment (submitted: June 13, 2020): 12
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: January 2021
• Estimated Primary Completion Date: January 2021 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Diagnosis of Type 2 Bipolar Disorder (BP-II) Depression

Exclusion Criteria:

• Comorbidities

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Tammy Miller; 410-938-3000; TMiller1@sheppardpratt.org

• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT04433845
• Other Study ID Numbers: 14947483
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Scott T. Aaronson, M.D, Sheppard Pratt Health System
• Study Sponsor: Sheppard Pratt Health System
• Collaborators: COMPASS Pathways

Investigators

• Principal Investigator: Scott Aaronson, MD; Sheppard Pratt Health System

• PRS Account: Sheppard Pratt Health System
• Verification Date: October 2020