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Long Term Follow Up Study to COMP 001 And COMP 003 Trials (P-TRD LTFU)

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ClinicalTrials.gov Identifier: NCT04519957
Recruitment Status : Recruiting
First Posted : August 20, 2020
Last Update Posted : March 3, 2021
Sponsor:
Information provided by (Responsible Party):
COMPASS Pathways

Tracking Information
First Submitted Date August 13, 2020
First Posted Date August 20, 2020
Last Update Posted Date March 3, 2021
Actual Study Start Date July 20, 2020
Estimated Primary Completion Date May 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 17, 2020)
Long-term efficacy of psilocybin [ Time Frame: up to 52 weeks ]
Use of new antidepressant treatment, hospitalisations for depression, suicidality, and depressive severity rated using the Montgomery and Asberg Depression Rating Scale (MADRS)
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: August 17, 2020)
  • Response, sustained response, remission and change in depression severity [ Time Frame: Up to 52 weeks ]
    Montgomery Asberg Depression Rating Scale (MADRS)
  • Psychosocial functioning and to predict durability of response to antidepressant treatment [ Time Frame: up to 52 weeks ]
    Work and Social Adjustment Scale (WSAS) score change from Baseline of the prior study
  • Functional impairment in work/school, social life, and family life. [ Time Frame: Up to 52 weeks ]
    Sheehan Disability Scale (SDS) score change from Baseline of the prior study
  • Safety of Psilocybin [ Time Frame: Up to 52 weeks ]
    Incidence and severity of Adverse Events (AEs) and Seroius Adverse Events (SAEs)
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Long Term Follow Up Study to COMP 001 And COMP 003 Trials (P-TRD LTFU)
Official Title Multicentre Study To Assess Safety And Efficacy Of Psilocybin In Patients With Treatment-Resistant Depression Following Completion Of COMP 001 And COMP 003 Trials (P-TRD LTFU)
Brief Summary The primary objective of this study is to assess the long-term efficacy of psilocybin with respect to use of new antidepressant treatment, hospitalisations for depression, suicidality, and depressive severity rated using the Montgomery and Asberg Depression Rating Scale (MADRS) over a total of 52 weeks (compared across the 1 mg, 10 mg and 25 mg psilocybin groups from COMP 001).
Detailed Description In this present study (COMP 004), the aim is to follow up participants from COMP 001 and COMP 003 in a long-term follow up study, with both remote and digital assessments, to explore the long term efficacy and safety of the three different doses of psilocybin (1 mg, 10 mg, and 25 mg) administered to patients with TRD as a monotherapy in COMP 001 and 25 mg psilocybin administered as an adjunct to an SSRI in COMP 003. Patients previously treated in COMP001 will be followed for approximately 40 weeks and patients previosuly treated in COMP003 will be followed for approximately 49 weeks giving a total follow up period of 52 weeks from psilocybin dosing.
Study Type Observational
Study Design Observational Model: Ecologic or Community
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population TRD patients who completed COMP001 or COMP003
Condition Treatment Resistant Depression
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: August 17, 2020)
150
Original Estimated Enrollment Same as current
Estimated Study Completion Date September 2022
Estimated Primary Completion Date May 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

Signed ICF Each participant having completed the final study visit of either COMP 001 or COMP 003 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

Exclusion Criteria:

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

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers Not Provided
Contacts
Contact: Sue Stansfield +447780523013 sue@compasspathways.com
Listed Location Countries Czechia,   Ireland,   Netherlands,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04519957
Other Study ID Numbers COMP004
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party COMPASS Pathways
Study Sponsor COMPASS Pathways
Collaborators Not Provided
Investigators Not Provided
PRS Account COMPASS Pathways
Verification Date March 2021