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History of Changes for Study: NCT04433845
The Safety and Efficacy of Psilocybin in Participants With Type 2 Bipolar Disorder (BP-II) Depression.
Latest version (submitted October 24, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 June 13, 2020 None (earliest Version on record)
2 July 8, 2020 Contacts/Locations and Study Status
3 October 9, 2020 Contacts/Locations and Study Status
4 March 2, 2021 Recruitment Status, Study Status and Contacts/Locations
5 October 28, 2021 Contacts/Locations and Study Status
6 October 24, 2022 Recruitment Status, Study Status, Contacts/Locations and Study Design
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Study NCT04433845
Submitted Date:  June 13, 2020 (v1)

Open or close this module Study Identification
Unique Protocol ID: 14947483
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.
Secondary IDs:
Open or close this module Study Status
Record Verification: June 2020
Overall Status: Not yet recruiting
Study Start: July 12, 2020
Primary Completion: January 2021 [Anticipated]
Study Completion: January 2021 [Anticipated]
First Submitted: June 13, 2020
First Submitted that
Met QC Criteria:
June 13, 2020
First Posted: June 16, 2020 [Actual]
Last Update Submitted that
Met QC Criteria:
June 13, 2020
Last Update Posted: June 16, 2020 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Sheppard Pratt Health System
Responsible Party: Principal Investigator
Investigator: Scott T. Aaronson, M.D
Official Title: Director, Clinical Research Programs
Affiliation: Sheppard Pratt Health System
Collaborators: COMPASS Pathways
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring:
Open or close this module Study Description
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:
Open or close this module Conditions
Conditions: Treatment Resistant Depression
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 2
Interventional Study Model: Single Group Assignment
Number of Arms: 1
Masking: None (Open Label)
Allocation: N/A
Enrollment: 12 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Psilocybin
25mg of Psilocybin
Drug: Psilocybin
Open-label
Open or close this module Outcome Measures
Primary Outcome Measures:
1. 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
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 65 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

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

Exclusion Criteria:

  • Comorbidities
Open or close this module Contacts/Locations
Central Contact Person: Marylu Ortiz, MSHS
Telephone: 4109383135
Email: mortiz@sheppardpratt.org
Study Officials: Scott Aaronson, MD
Principal Investigator
Sheppard Pratt Health System
Locations:
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Citations:
Links:
Available IPD/Information:

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