Efficacy, Safety, and Tolerability of Two Administrations of COMP360 in Participants With TRD
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| ClinicalTrials.gov Identifier: NCT05711940 |
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Recruitment Status :
Recruiting
First Posted : February 3, 2023
Last Update Posted : April 17, 2024
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Sponsor:
COMPASS Pathways
Information provided by (Responsible Party):
COMPASS Pathways
- Study Details
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Brief Summary:
Efficacy, Safety, and Tolerability of two administrations of COMP360 in participants with treatment-resistant depression (TRD)
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Treatment Resistant Depression | Drug: Psilocybin | Phase 3 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 568 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| 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 |
| Actual Study Start Date : | February 14, 2023 |
| Estimated Primary Completion Date : | March 2025 |
| Estimated Study Completion Date : | May 2025 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Depression
| Arm | Intervention/treatment |
|---|---|
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Experimental: 25 mg COMP360 Psilocybin
25 mg COMP360 Psilocybin
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Drug: Psilocybin
COMP360 Psilocybin administered under supportive conditions
Other Name: COMP360 |
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Experimental: 10 mg COMP360 Psilocybin
10 mg COMP360 Psilocybin
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Drug: Psilocybin
COMP360 Psilocybin administered under supportive conditions
Other Name: COMP360 |
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Active Comparator: 1 mg COMP360 Psilocybin
1 mg COMP360 Psilocybin, active comparator
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Drug: Psilocybin
COMP360 Psilocybin administered under supportive conditions
Other Name: COMP360 |
Primary Outcome Measures :
- COMP360 25 mg versus COMP360 1 mg for the change from baseline in MADRS total score. [ Time Frame: Week 6 ]Montgomery-Åsberg Depression Rating Scale (MADRS) is a 10-item clinician rated scale measuring depression severity
Secondary Outcome Measures :
- COMP360 25 mg versus COMP360 1 mg for the change from baseline in Sheehan Disability Scale (SDS) total score. [ Time Frame: Week 6 ]Sheehan Disability Scale (SDS) is a brief, five-item self report inventory that assesses functional impairment in work/school, social life, and family life.
- COMP360 25 mg versus COMP360 10 mg for the change from baseline in MADRS total score. [ Time Frame: Week 6 ]Montgomery-Åsberg Depression Rating Scale (MADRS) is a 10-item clinician rated scale measuring depression severity
- COMP360 25 mg versus COMP360 10 mg for the change from baseline in Sheehan Disability Scale (SDS) total score. [ Time Frame: Week 6 ]Sheehan Disability Scale (SDS) is a brief, five-item self report inventory that assesses functional impairment in work/school, social life, and family life.
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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
- 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
- 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05711940
Contacts
| Contact: Medical Director, MD | COMP006@compasspathways.com |
Locations
Show 45 study locations
Sponsors and Collaborators
COMPASS Pathways
| Responsible Party: | COMPASS Pathways |
| ClinicalTrials.gov Identifier: | NCT05711940 |
| Other Study ID Numbers: |
COMP 006 |
| First Posted: | February 3, 2023 Key Record Dates |
| Last Update Posted: | April 17, 2024 |
| Last Verified: | April 2024 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by COMPASS Pathways:
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psilocybin |
Additional relevant MeSH terms:
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Depression Depressive Disorder, Treatment-Resistant Behavioral Symptoms Depressive Disorder Mood Disorders |
Mental Disorders Psilocybin Hallucinogens Physiological Effects of Drugs Psychotropic Drugs |