Clinical trial NCT04519957: 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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Treatment Resistant Depression
Lead sponsor: COMPASS Pathways
Sponsor class: INDUSTRY
First posted: 2020-08-20
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: TRD patients who completed COMP001 or COMP003

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.

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

Primary outcomes:
measure: Long-term efficacy of psilocybin
timeFrame: up to 52 weeks
Secondary outcomes:
measure: Response, sustained response, remission and change in depression severity
timeFrame: Up to 52 weeks
measure: Psychosocial functioning and to predict durability of response to antidepressant treatment
timeFrame: up to 52 weeks
measure: Functional impairment in work/school, social life, and family life.
timeFrame: Up to 52 weeks
measure: Safety of Psilocybin
timeFrame: Up to 52 weeks
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Kadima Neuropsychiatry Institute
state: California
city: San Diego
country: United States
facility: Altman Clinical and Translational Research Institute, University of California
state: California
city: Atlanta
country: United States
facility: Mood and Anxiety Disorders Program Emory University School of Medicine
state: Georgia
city: Houston
country: United States
facility: UT Center of Excellence on Mood Disorders, University of Texas Health Science Center
state: Texas
city: Klecany
country: Czechia
facility: National Institute of Mental Health Czech Republic
city: Dublin
country: Ireland
facility: Sheaf House, Tallaght Hospital
city: Groningen
country: Netherlands
facility: Groningen University Medical Centre
city: London
country: United Kingdom
facility: Kings College London, Institute of Psychiatry, Psychology and Neurology
Study officials:
References: