The Safety and Efficacy of Psilocybin in Participants With Type 2 Bipolar Disorder (BP-II) Depression.
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT04433845 |
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Recruitment Status :
Recruiting
First Posted : June 16, 2020
Last Update Posted : November 1, 2021
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Sponsor:
Sheppard Pratt Health System
Collaborator:
COMPASS Pathways
Information provided by (Responsible Party):
Scott T. Aaronson, M.D, Sheppard Pratt Health System
| Tracking Information | |||||||||
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| First Submitted Date ICMJE | June 13, 2020 | ||||||||
| First Posted Date ICMJE | June 16, 2020 | ||||||||
| Last Update Posted Date | November 1, 2021 | ||||||||
| Actual Study Start Date ICMJE | March 1, 2021 | ||||||||
| Estimated Primary Completion Date | August 2022 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | The Safety and Efficacy of Psilocybin in Participants With Type 2 Bipolar Disorder (BP-II) Depression. | ||||||||
| Official Title ICMJE | 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 ICMJE | Interventional | ||||||||
| Study Phase ICMJE | Phase 2 | ||||||||
| Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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| Condition ICMJE | Treatment Resistant Depression | ||||||||
| Intervention ICMJE | Drug: Psilocybin
Open-label
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| Study Arms ICMJE | Experimental: Psilocybin
25mg of Psilocybin
Intervention: Drug: Psilocybin
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE |
12 | ||||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||||
| Estimated Study Completion Date ICMJE | August 2022 | ||||||||
| Estimated Primary Completion Date | August 2022 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years to 65 Years (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | United States | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT04433845 | ||||||||
| Other Study ID Numbers ICMJE | 14947483 | ||||||||
| Has Data Monitoring Committee | Not Provided | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Current Responsible Party | Scott T. Aaronson, M.D, Sheppard Pratt Health System | ||||||||
| Original Responsible Party | Same as current | ||||||||
| Current Study Sponsor ICMJE | Sheppard Pratt Health System | ||||||||
| Original Study Sponsor ICMJE | Same as current | ||||||||
| Collaborators ICMJE | COMPASS Pathways | ||||||||
| Investigators ICMJE |
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| PRS Account | Sheppard Pratt Health System | ||||||||
| Verification Date | October 2021 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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