The Safety and Efficacy of Psilocybin in Participants With Type 2 Bipolar Disorder (BP-II) Depression.
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ClinicalTrials.gov Identifier: NCT04433845 |
Recruitment Status :
Active, not recruiting
First Posted : June 16, 2020
Last Update Posted : October 25, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Treatment Resistant Depression | Drug: Psilocybin | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 15 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | The Safety and Efficacy of Psilocybin in Participants With Type 2 Bipolar Disorder (BP-II) Depression. |
Actual Study Start Date : | March 1, 2021 |
Estimated Primary Completion Date : | January 15, 2023 |
Estimated Study Completion Date : | April 15, 2023 |
Arm | Intervention/treatment |
---|---|
Experimental: Psilocybin
25mg of Psilocybin
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Drug: Psilocybin
Open-label |
- 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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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Diagnosis of Type 2 Bipolar Disorder (BP-II) Depression
Exclusion Criteria:
- Comorbidities
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04433845
United States, Maryland | |
Sheppard Pratt | |
Baltimore, Maryland, United States, 21204 |
Principal Investigator: | Scott Aaronson, MD | Sheppard Pratt Health System |
Responsible Party: | Scott T. Aaronson, M.D, Director, Clinical Research Programs, Sheppard Pratt Health System |
ClinicalTrials.gov Identifier: | NCT04433845 |
Other Study ID Numbers: |
14947483 |
First Posted: | June 16, 2020 Key Record Dates |
Last Update Posted: | October 25, 2022 |
Last Verified: | October 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Depressive Disorder Bipolar Disorder Depressive Disorder, Treatment-Resistant Mood Disorders Mental Disorders Bipolar and Related Disorders |
Psilocybin Depression Behavioral Symptoms Hallucinogens Physiological Effects of Drugs Psychotropic Drugs |