Long Term Follow up study for subjects that participated in COMP001 and COMP003 trial

A 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

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-001348-25-PT

Enrollment

150

Registered

2020-05-07

Start date

2020-07-08

Completion date

Unknown

Last updated

2024-02-19

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

Conditions

Treatment-Resistant Depression (P-TRD) MedDRA version: 21.1 Level: LLT Classification code 10025463 Term: Major depressive disorder, single episode System Organ Class: 100000004873 MedDRA version: 21.1 Level: LLT Classification code 10025454 Term: Major depressive disorder, recurrent episode System Organ Class: 100000004873

Interventions

Product Name: Psilocybin 5 mg Pharmaceutical Form: Capsule INN or Proposed INN: PSILOCYBIN CAS Number: 520-52-5 Other descriptive name: Psilocybin Concentration unit: mg milligram(s) Concentration typ

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Main Objective: 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).;Secondary Objective: The secondary objectives are: •To assess response, sustained response, remission and change in depression severity (compared across all treatment groups – 1 mg, 10 mg and 25 mg psilocybin in COMP 001 and 25 mg as an adjunct to SSRIs in COMP 003) over a total of 52 weeks •To evaluate the effect of psilocybin on functioning and associated disability compared across the groups over a total of 52 weeks ;Primary end point(s): The primary endpoint of this long-term follow up study will be time to any of the following depression-related events (from baseline ie one day prior to single dose psilocybin administration dosing in the prior study) in participants recruited from the COMP 001 study (presented for the 1 mg , 10 mg, and 25 mg psilocybin therapy groups): •Initiation of new antidepressant treatment (first new antidepressant treatment in time period only) •Hospitalisation due to depression •Suicide attempt, suicide prevention, or completed suicide •Increased suicidality measured by worsening on MADRS item 10 i.e. either 1) a score of 5 or 6 on MADRS item 10; or 2) an increase of 2 points compared to Baseline in the prior study MADRS 10 score •Worsening in the MADRS clinician rated severity scale: i.e. a 5 point worsening compared to baseline score in the prior study at any timepoint post-baseline of the original study; or a worsening of =5 points (providing the highest score is =10) across two or more consecutive visits (in this case the first date of the =5 point increase will be classed as the event and at the final study visit the =5 point worsening wil	—

Measure

Time frame

Main Objective: 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).;Secondary Objective: The secondary objectives are: •To assess response, sustained response, remission and change in depression severity (compared across all treatment groups – 1 mg, 10 mg and 25 mg psilocybin in COMP 001 and 25 mg as an adjunct to SSRIs in COMP 003) over a total of 52 weeks •To evaluate the effect of psilocybin on functioning and associated disability compared across the groups over a total of 52 weeks ;Primary end point(s): The primary endpoint of this long-term follow up study will be time to any of the following depression-related events (from baseline ie one day prior to single dose psilocybin administration dosing in the prior study) in participants recruited from the COMP 001 study (presented for the 1 mg , 10 mg, and 25 mg psilocybin therapy groups): •Initiation of new antidepressant treatment (first new antidepressant treatment in time period only) •Hospitalisation due to depression •Suicide attempt, suicide prevention, or completed suicide •Increased suicidality measured by worsening on MADRS item 10 i.e. either 1) a score of 5 or 6 on MADRS item 10; or 2) an increase of 2 points compared to Baseline in the prior study MADRS 10 score •Worsening in the MADRS clinician rated severity scale: i.e. a 5 point worsening compared to baseline score in the prior study at any timepoint post-baseline of the original study; or a worsening of =5 points (providing the highest score is =10) across two or more consecutive visits (in this case the first date of the =5 point increase will be classed as the event and at the final study visit the =5 point worsening wil

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Secondary

Measure	Time frame
Secondary end point(s): The secondary endpoints are: •Change in MADRS total score from Baseline of the prior study to 12 , 16, 20, 24, 28. 40, and 52 weeks post psilocybin •The proportion of participants with a response (defined as a = 50% improvement in MADRS total score from Baseline of the prior study) at Week 12 , 16, 20, 24, 28, 40, and 52 post psilocybin •The proportion of participants with remission (defined as a MADRS total score = 10) at Week 12, 16, 20, 24, 28, 40, and 52 post psilocybin •The proportion of participants who have a sustained response at Week 12, 16, 20, 24, 28, 40 and 52. Sustained response is defined as the proportion of patients fulfilling response criteria at any visit up to and including Week 3 post-dosing (in the lead-in studies), that also fulfills response criteria at all subsequent visits up to and including Week 12, 16, 20, 24, 28, 40, and 52 post psilocybin. Response is defined as = 50% decrease in MADRS total score from Baseline of the prior study •Longitudinal depression severity: the difference in the area under the curve between 1mg, 10 mg, and 25 mg psilocybin monotherapy and 25 mg psilocybin adjunctive therapy over 52 weeks post-baseline in QIDS-SR-16 total score •Work and Social Adjustment (WSAS) score change from Baseline of the prior study to week 12, 18, 24, 30, 36, 42, 48 •Sheehan Disability Scale (SDS) score change from Baseline of the prior study to week 12, 16, 20, 24, 28, 40, and 52 post psilocybin ;Timepoint(s) of evaluation of this end point: 31JUL2022	—

Measure

Time frame

Secondary end point(s): The secondary endpoints are: •Change in MADRS total score from Baseline of the prior study to 12 , 16, 20, 24, 28. 40, and 52 weeks post psilocybin •The proportion of participants with a response (defined as a = 50% improvement in MADRS total score from Baseline of the prior study) at Week 12 , 16, 20, 24, 28, 40, and 52 post psilocybin •The proportion of participants with remission (defined as a MADRS total score = 10) at Week 12, 16, 20, 24, 28, 40, and 52 post psilocybin •The proportion of participants who have a sustained response at Week 12, 16, 20, 24, 28, 40 and 52. Sustained response is defined as the proportion of patients fulfilling response criteria at any visit up to and including Week 3 post-dosing (in the lead-in studies), that also fulfills response criteria at all subsequent visits up to and including Week 12, 16, 20, 24, 28, 40, and 52 post psilocybin. Response is defined as = 50% decrease in MADRS total score from Baseline of the prior study •Longitudinal depression severity: the difference in the area under the curve between 1mg, 10 mg, and 25 mg psilocybin monotherapy and 25 mg psilocybin adjunctive therapy over 52 weeks post-baseline in QIDS-SR-16 total score •Work and Social Adjustment (WSAS) score change from Baseline of the prior study to week 12, 18, 24, 30, 36, 42, 48 •Sheehan Disability Scale (SDS) score change from Baseline of the prior study to week 12, 16, 20, 24, 28, 40, and 52 post psilocybin ;Timepoint(s) of evaluation of this end point: 31JUL2022

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Countries

Canada, Czech Republic, Denmark, Germany, Ireland, Netherlands, Portugal, Spain, United Kingdom, United States

Contacts

Public ContactEkaterina Malievskaia

COMPASS Pathways, Ltd.

katya@compasspathways.com079 2087 6562

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026