EUCTR2020-001348-25-DEActive, not recruitingPhase 1
A multicentre study to assess safety and efficacy of COMP360 in patients with treatment-resistant depression following completion of COMP 001 and COMP 003 trials (P-TRD LTFU)
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- COMPASS Pathfinder, Ltd
- Enrollment
- 150
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1)Signed ICF
- •2)Each participant having completed the final study visit of either COMP 001 or COMP 003
- •3)Ability to complete all protocol required assessment tools (including having access to the internet in order to complete the digital assessments) without any assistance or alteration to the copyrighted assessments, and to comply with all study visits
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 126
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 24
Exclusion Criteria
- •1)Subject has any condition, for which in the opinion of the investigator, participation would not be in the interest of the subject eg participation could compromise the wellbeing of the participant or prevent, limit, or confound the protocol-specified assessments
Investigators
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ong Term Follow up study for subjects that participated in COMP001 and COMP003 trialTreatment-Resistant Depression (P-TRD)MedDRA version: 21.1Level: LLTClassification code 10025463Term: Major depressive disorder, single episodeSystem Organ Class: 100000004873MedDRA version: 21.1Level: LLTClassification code 10025454Term: Major depressive disorder, recurrent episodeSystem Organ Class: 100000004873EUCTR2020-001348-25-DKCOMPASS Pathfinder, Ltd150