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

Psilocybin

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.

Intervention / Treatment

  • Psilocybin (DRUG)
    Open-label

Condition or Disease

  • Treatment Resistant Depression

Phase

  • Phase 2

    • Study Design

    Study type: INTERVENTIONAL
    Status: Active, not recruiting
    Study results: No Results Available
    Age: 18 Years to 65 Years
    Enrollment: 15 (ACTUAL)
    Funded by: Other|Industry
    Allocation: N/A
    Primary Purpose: Treatment

    Masking

    Clinical Trial Dates

    Start date: Mar 01, 2021 ACTUAL
    Primary Completion: Jan 15, 2023 ESTIMATED
    Completion Date: Apr 15, 2023 ESTIMATED
    Study First Posted: Jun 16, 2020 ACTUAL
    Results First Posted: Aug 30, 2020
    Last Updated: Oct 24, 2022

    Sponsors / Collaborators

    Lead Sponsor: Sheppard Pratt Health System
    Responsible Party: N/A

    Location

    Baltimore, Maryland, USA

    Participant Groups

    • 25mg of Psilocybin

    Eligibility Criteria

    Sex: All
    Minimum Age: 18
    Maximum Age: 65
    Age Groups: Adult / Older Adult
    Healthy Volunteers: Yes

    Inclusion Criteria:

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

    Exclusion Criteria:

    * Comorbidities

    Primary Outcomes

    • 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

    More Details

    NCT Number: NCT04433845
    Other IDs: 14947483
    Study URL: https://clinicaltrials.gov/study/NCT04433845
    Last updated: Sep 29, 2023