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

Treatment Resistant Depression Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04519957
• Other study ID #: COMP004
• Status: Completed
• Start date: July 20, 2020
• Est. completion date: August 11, 2022

Study information

• Verified date: September 2022
• Source: COMPASS Pathways
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: August 11, 2022
• Est. primary completion date: August 11, 2022
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder, Treatment-Resistant
• Treatment Resistant Depression

Locations

Country	Name	City	State
Czechia	National Institute of Mental Health Czech Republic	Klecany
Ireland	Sheaf House, Tallaght Hospital	Dublin
Netherlands	Groningen University Medical Centre	Groningen
United Kingdom	Kings College London, Institute of Psychiatry, Psychology and Neurology	London
United States	Mood and Anxiety Disorders Program Emory University School of Medicine	Atlanta	Georgia
United States	UT Center of Excellence on Mood Disorders, University of Texas Health Science Center	Houston	Texas
United States	Kadima Neuropsychiatry Institute	La Jolla	California
United States	Altman Clinical and Translational Research Institute, University of California	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
COMPASS Pathways

Countries where clinical trial is conducted

United States,  Czechia,  Ireland,  Netherlands,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Long-term efficacy of psilocybin	Use of new antidepressant treatment, hospitalisations for depression, suicidality, and depressive severity rated using the Montgomery and Asberg Depression Rating Scale (MADRS)	up to 52 weeks
Secondary	Response, sustained response, remission and change in depression severity	Montgomery Asberg Depression Rating Scale (MADRS)	Up to 52 weeks
Secondary	Psychosocial functioning and to predict durability of response to antidepressant treatment	Work and Social Adjustment Scale (WSAS) score change from Baseline of the prior study	up to 52 weeks
Secondary	Functional impairment in work/school, social life, and family life.	Sheehan Disability Scale (SDS) score change from Baseline of the prior study	Up to 52 weeks
Secondary	Safety of Psilocybin	Incidence and severity of Adverse Events (AEs) and Seroius Adverse Events (SAEs)	Up to 52 weeks