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

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)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04519957

Enrollment

Registered

2020-08-20

Start date

2020-07-20

Completion date

2022-08-11

Last updated

2022-09-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Treatment Resistant Depression

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.

Interventions

None listed

Study design

Observational model

ECOLOGIC_OR_COMMUNITY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Long-term efficacy of psilocybin	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)

Secondary

Measure	Time frame	Description
Response, sustained response, remission and change in depression severity	Up to 52 weeks	Montgomery Asberg Depression Rating Scale (MADRS)
Psychosocial functioning and to predict durability of response to antidepressant treatment	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.	Up to 52 weeks	Sheehan Disability Scale (SDS) score change from Baseline of the prior study
Safety of Psilocybin	Up to 52 weeks	Incidence and severity of Adverse Events (AEs) and Seroius Adverse Events (SAEs)

Countries

Czechia, Ireland, Netherlands, United Kingdom, United States

Outcome results