IRB Study Number 23-1051
Status Recruiting
Location Lutheran Hospital
Institute Neurological Institute
Description
The main purpose of this study is to investigate how well two initial administrations of COMP360 psilocybin works to lessen the severity of symptoms in treatment resistant depression within the first 6 weeks of treatment when administered with psychological support and to determine the durability and long-term safety of COMP360 over approximately one year (55 to 62 weeks). The study will also be investigating the safety of COMP360 psilocybin as well as how tolerable it is.
COMP360 is an investigational (experimental) drug that is a human-made form of the naturally occurring chemical compound, psilocybin. It is not approved by the Food and Drug Administration (FDA). Psilocybin is found in some species of mushrooms, most commonly known as “magic mushrooms”. Psilocybin (and therefore COMP360) is a psychedelic and controlled drug, and its use outside of approved research is prohibited by law. Research suggests psilocybin may help in treating depression.
Study participation involves administration of COMP360 at multiple sessions and doses as well as engaging with a study therapist. You will also be asked questions about your mood, quality of life, medical and treatment history, give blood and urine samples and other tests, which can be discussed with the study team.
Inclusion 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
Exclusion Criteria
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
