Status:
COMPLETED
The Safety and Efficacy Of Psilocybin as an Adjunctive Therapy in Participants With Treatment Resistant Depression
Lead Sponsor:
COMPASS Pathways
Conditions:
Treatment Resistant Depression
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The Safety and Efficacy of Psilocybin as an Adjunctive Therapy in Participants with Treatment-Resistant Depression
Detailed Description
A recent open label study of the effects of psilocybin in participants with treatment-resistant depression (TRD) showed rapid significant decrease of depressive symptoms after treatment with psilocybi...
Eligibility Criteria
Inclusion
- Signed ICF.
- 18 years of age or older
- At least moderate MDD
- Hamilton Depression Rating Scale (17 item) score ≥18
- Currently receiving treatment with a selective serotonin reuptake inhibitor
- Failure to respond to an adequate dose and duration of 2, 3, or 4 pharmacological treatments
- McLean Screening Instrument for Borderline Personality Disorder \<7 at Screening (V1).
- Ability to complete all protocol required assessment tools without any assistance or alteration to the copyrighted assessments, and to comply with all study visits.
Exclusion
- Psychiatric
Key Trial Info
Start Date :
August 10 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 14 2021
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT04739865
Start Date
August 10 2020
End Date
October 14 2021
Last Update
November 9 2023
Active Locations (2)
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1
Kadima Neuropsychiatry Institute
La Jolla, California, United States, 92037
2
Sheaf House, Tallaght Hospital
Dublin, Ireland