Efficacy, Safety, and Tolerability of Two Administrations of COMP360 in Participants With TRD

Treatment Resistant Depression Clinical Trial

Official title:

A Phase III, Multicentre, Randomised, Double-blind, Controlled Study to Investigate the Efficacy, Safety, and Tolerability of Two Administrations of COMP360 in Participants With Treatment-resistant Depression

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05711940
• Other study ID #: COMP 006
• Status: Recruiting
• Phase: Phase 3
• Start date: February 14, 2023
• Est. completion date: May 2025

Study information

• Verified date: June 2024
• Source: COMPASS Pathways
• Contact: Medical Director, MD
• Email: COMP006[@]compasspathways.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Efficacy, Safety, and Tolerability of two administrations of COMP360 in participants with treatment-resistant depression (TRD)

Description:

This is a phase III, international, multi-centre, randomised, parallel group, fixed repeat dose, double-blind, controlled study. The study population will include participants aged ≥18 years with TRD. Overall, 568 participants are to be randomised in a 2:1:1 ratio to receive COMP360 25 mg, 10 mg or 1 mg. The study will last up to 16 weeks including a three- to ten-week Screening Period and six-week follow-up from investigational product (IP) administration. In this study, the aim is to assess the efficacy of COMP360, administered with psychological support in adult participants with TRD, in improving symptoms of depression.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 568
• Est. completion date: May 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Key Inclusion Criteria:

1. Aged =18 years at Screening

2. Major depression without psychotic features (single or recurrent episode as informed by the Diagnostic and Statistical Manual of Mental Disorders, 5th edition [DSM-5])

3. If the current major depressive episode is the participant's first lifetime episode of depression, the length of the current episode must be =3 months and =2 years at Screening

4. MADRS total score =20 at Screening and Baseline to ensure at least moderate severity of depression

5. TRD, defined as failure to respond to an adequate dose and duration of two, three, or four different pharmacological treatments for the current episode as determined through the Massachusetts General Hospital Antidepressant Treatment Response Questionnaire (MGH-ATRQ) and using the supplementary advice on additional antidepressants not included in MGH-ATRQ

6. At Screening, agreement to discontinue all prohibited medications

Key Exclusion Criteria:

1. Prior or ongoing bipolar disorder, any psychotic disorder, including schizophrenia, schizophreniform disorder, schizoaffective disorder, brief psychotic disorder (unless substance induced or due to a medical condition), antisocial personality disorder as assessed by a structured clinical interview (MINI 7.0.2)

2. Lifetime paranoid, schizoid, schizotypal, histrionic, narcissistic personality disorder, or any ongoing serious psychiatric comorbidity based on medical history and clinical judgement

3. Borderline personality disorder as demonstrated by medical history or the Mini International Neuropsychiatric Interview Plus (MINI plus) - borderline personality disorder module

4. Ongoing post-traumatic stress disorder, obsessive-compulsive disorder, or anorexia nervosa as assessed by medical history and a structured clinical interview (MINI 7.0.2)

5. Psychiatric inpatient within the past 12 months prior to Screening

6. Use of electroconvulsive therapy, deep brain stimulation, or vagus nerve stimulation during the current depressive episode

7. Transcranial magnetic stimulation within the past six months prior to Screening

8. Current enrolment in a psychological therapy programme that will not remain stable for the duration of the study. Psychological therapies cannot have been initiated within 30 days prior to Screening

9. Exposure to COMP360 psilocybin therapy prior to Screening

Related Conditions & MeSH terms

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

Intervention

Drug:
• Psilocybin
COMP360 Psilocybin administered under supportive conditions

Locations

Country	Name	City	State
Canada	Chatham-Kent Clnical Trials Centre	Chatham
Canada	Centre for Addiction and Mental Health (CAMH)	Toronto
Canada	Centre for Neurology Studies	Vancouver
Canada	Medical Arts Research Group	Vancouver
France	Centre Hospitalier Sainte Anne	Paris
France	Centre Hospitalier Sainte Anne - Clinique des Maladies Mentales et de l'Encephale (CMME)	Paris
France	Ghu-Centre Hospitalier Sainte Anne, Centre de Recherche Clinique	Paris
Ireland	Tallaght University Hospital	Dublin
Ireland	La Nua Day Hospital Mental Health Centre	Galway
Spain	Hospital Clinic de Barcelona	Barcelona
Spain	Parc Sanitari Sant Joan de Deu (Sant Joan de Deu Serveis de Salut Mental)	Barcelona
Spain	Hospital Universitario Fundacion Jimenez Diaz	Madrid
Spain	FIDMAG Hermanas Hospitalarias	Sant Boi De Llobregat
Spain	Hospital Universitario Río Hortega de Valladolid	Valladolid
Spain	Hospital Provincial de Zamora - Servicio de Psiquiatria	Zamora
Sweden	Lunds Universitet - Medicinska Fakulteten (Lund University Faculty of Medicine)	Lund
United Kingdom	Grounded Research Hub - Rotherham Doncaster & South Humber NHS Foundation Trust	Doncaster
United Kingdom	Clerkenwell Health	London
United Kingdom	King's College London - Institute of Psychiatry, Psychology	London
United Kingdom	St. Pancras Clinical Research	London
United Kingdom	Cumbria, Northumberland, Tyne and Wear NHS Foundation Trust - Wolfson Research Centre	Newcastle
United Kingdom	University Of Nottingham/Nottinghamshire Healthcare Trust, Institute Of Mental Health	Nottingham
United Kingdom	Sheffield Health and Social Care NHS Foundation Trust	Sheffield
United States	Michigan Clinical Research Institute PC	Ann Arbor	Michigan
United States	University Of Michigan Comprehensive Depression Center	Ann Arbor	Michigan
United States	Atlanta Center for Medical Research	Atlanta	Georgia
United States	The University of Texas at Austin - Dell Medical School	Austin	Texas
United States	Clinical Innovations, Inc.	Bellflower	California
United States	Hassman Research Institute	Berlin	New Jersey
United States	Rush University Medical Center	Chicago	Illinois
United States	University of Cincinnati, Department of Psychiatry & Behavirol Neuroscience	Cincinnati	Ohio
United States	Cleveland Clinic - Lutheran Hospital	Cleveland	Ohio
United States	The Ohio State University	Columbus	Ohio
United States	Center for Depression Research and Clinical Care	Dallas	Texas
United States	iResearch Atlanta	Decatur	Georgia
United States	North Texas Clinical Trials	Fort Worth	Texas
United States	Innovative Clinical Research, Inc.	Lauderhill	Florida
United States	Suburban Research Associates	Media	Pennsylvania
United States	Behavioral Clinical Research, Inc.	Miami Lakes	Florida
United States	Catalina Research Institute, LLC	Montclair	California
United States	Fieve Clinical Research, Inc	New York	New York
United States	Spectrum Neuroscience and Treatment Institute	New York	New York
United States	Health Synergy Clinical Research	Okeechobee	Florida
United States	HCA Healthcare Research Institute - Medical City Green Oaks Hospital	Plano	Texas
United States	Princeton Medical Institute	Princeton	New Jersey
United States	CITrials	Riverside	California
United States	The University of Utah - Huntsman Mental Health Institute	Salt Lake City	Utah
United States	Syrentis Clinical Research	Santa Ana	California
United States	Seattle Neuropsychiatric Treatment Center	Seattle	Washington
United States	Richmond Behavioral Associates	Staten Island	New York
United States	University South Florida	Tampa	Florida
United States	Pacific Clinical Research Management Group, LLC	Upland	California

Sponsors (1)

Lead Sponsor	Collaborator
COMPASS Pathways

Countries where clinical trial is conducted

United States,  Canada,  France,  Ireland,  Spain,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	COMP360 25 mg versus COMP360 1 mg for the change from baseline in MADRS total score.	Montgomery-Åsberg Depression Rating Scale (MADRS) is a 10-item clinician rated scale measuring depression severity	Week 6
Secondary	COMP360 25 mg versus COMP360 1 mg for the change from baseline in Sheehan Disability Scale (SDS) total score.	Sheehan Disability Scale (SDS) is a brief, five-item self report inventory that assesses functional impairment in work/school, social life, and family life.	Week 6
Secondary	COMP360 25 mg versus COMP360 10 mg for the change from baseline in MADRS total score.	Montgomery-Åsberg Depression Rating Scale (MADRS) is a 10-item clinician rated scale measuring depression severity	Week 6
Secondary	COMP360 25 mg versus COMP360 10 mg for the change from baseline in Sheehan Disability Scale (SDS) total score.	Sheehan Disability Scale (SDS) is a brief, five-item self report inventory that assesses functional impairment in work/school, social life, and family life.	Week 6