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

Sheppard Pratt Health System

Status and phase: Active, not recruiting; Phase 2

Conditions: Treatment Resistant Depression

Treatments: Drug: Psilocybin

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04433845

14947483

Details and patient eligibility

About

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.

Enrollment: 15 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Comorbidities

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Psilocybin

Experimental group

Description:

25mg of Psilocybin

Treatment:

Drug: Psilocybin