A Phase II, Multicentre, Randomised, Double-blind, Controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Efficacy of COMP360 in Participants With Recurrent Major Depressive Disorder

Major Depressive Disorder Clinical Trial

Official title:

A Phase II, Multicentre, Randomised, Double-blind, Controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Efficacy of COMP360 in Participants With Recurrent Major Depressive Disorder

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05733546
• Other study ID #: COMP 104
• Status: Recruiting
• Phase: Phase 2
• Start date: January 30, 2023
• Est. completion date: November 2024

Study information

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

Clinical Trial Summary

Safety, Tolerability, pharmacokinetics and efficacy of a single administration of COMP360 in participants with recurrent Major Depressive Disorder.

Description:

This is a phase II, multi-centre, randomised, double-blind, controlled study. The study population will include participants aged ≥18 years with recurrent Major Depressive Disorder (MDD) with up to four prior treatment failures of an antidepressant in their current depressive episode.

Overall, 102 participants will be randomised in a 1:1:1 ratio to receive COMP360 25 mg, COMP360 10mg or COMP360 1 mg.

In this study the aim is to investigate the safety and tolerability of COMP360, administered with psychological support, in adult participants with MDD with one prior treatment failure. In addition, pharmacokinetics and efficacy of COMP360 will be investigated.

The study will last up to 16 weeks including a three- to ten-week Screening Period and a six-week follow-up from investigational product (IP) administration.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 102
• Est. completion date: November 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Key Inclusion Criteria:

• Aged =18 years at Screening

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

• 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

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

• Failure to respond to an adequate dose and duration of up to four pharmacological treatment 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.

• At Screening, agreement to discontinue all prohibited medications.

Key Exclusion Criteria:

• 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)

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

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

• 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) Psychiatric inpatient within the past 12 months prior to Screening

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

• Transcranial magnetic stimulation within the past six months prior to Screening

• 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

• Exposure to COMP360 psilocybin therapy prior to Screening

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Drug:
• Psilocybin
COMP360 Psilocybin administered under supportive conditions

Locations

Country	Name	City	State
United States	Clinical Neuroscience Solutions Inc	Jacksonville	Florida
United States	Kadima Neuropsychiatry Institute	La Jolla	California
United States	Aims Trial	Plano	Texas
United States	Sunstone Therapies	Rockville	Maryland
United States	Elixia MA, LLC	Springfield	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
COMPASS Pathways

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability of COMP360 Psilocybin	Proportion of patients with adverse events (AEs)	Up to Week 6
Secondary	Pharmacokinetics of COMP360 Psilocybin	Plasma concentrations of psilocybin, psilocin, 4-hydroxyindoleacetic acid (4-HIAA) and psilocin-O-glucuronide post-COMP360 administration on Day 1	Day 1
Secondary	Change from baseline in MADRS total score at Week 3 and Week 6 for COMP360 25 mg versus COMP360 1 mg	Montgomery-Åsberg Depression Rating Scale (MADRS) is a 10-item clinician rated scale measuring depression severity	Week 3 and Week 6