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

NCT ID: NCT04433845

Last Updated: 2022-10-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-01

Study Completion Date

2023-04-15

Brief Summary

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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

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Conditions

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Treatment Resistant Depression

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Psilocybin

25mg of Psilocybin

Group Type EXPERIMENTAL

Psilocybin

Intervention Type DRUG

Open-label

Interventions

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Psilocybin

Open-label

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Comorbidities
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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COMPASS Pathways

INDUSTRY

Sponsor Role collaborator

Sheppard Pratt Health System

OTHER

Sponsor Role lead

Responsible Party

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Scott T. Aaronson, M.D

Director, Clinical Research Programs

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Scott Aaronson, MD

Role: PRINCIPAL_INVESTIGATOR

Sheppard Pratt Health System

Locations

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Sheppard Pratt

Baltimore, Maryland, United States

Site Status

Countries

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United States

Other Identifiers

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14947483

Identifier Type: -

Identifier Source: org_study_id

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