Trial studying safety and effects for Treatment Resistant Depression
Official title Efficacy, Safety, and Tolerability of Two Administrations of COMP360 in Participants With TRD
ClinicalTrials.gov ID: NCT05711940
What this study is testing
What is Psilocybin?
Psilocybin is an investigational medicine, being studied as a potential treatment for treatment resistant depression.
Also referred to as COMP360.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Efficacy, Safety, and Tolerability of two administrations of COMP360 in participants with treatment-resistant depression (TRD)
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- If the current major depressive episode is the participant's first lifetime episode of depression, the length of the current episode must be ≥3...
- 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...
You likely can't join if
- Prior or ongoing bipolar disorder, any psychotic disorder, including schizophrenia, schizophreniform disorder, schizoaffective disorder, brief...
- Lifetime paranoid, schizoid, schizotypal, histrionic, narcissistic personality disorder, or any ongoing serious psychiatric comorbidity based on...
- Borderline personality disorder as demonstrated by medical history or the Mini International Neuropsychiatric Interview Plus (MINI plus) - borderline...
- Ongoing post-traumatic stress disorder, obsessive-compulsive disorder, or anorexia nervosa as assessed by medical history and a structured clinical...
- 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
See the full eligibility 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...
- At Screening, agreement to discontinue all prohibited medications Key
- 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)...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Gilbert, Arizona, United States
- Bellflower, California, United States
- Encino, California, United States
- La Jolla, California, United States
- Los Angeles, California, United States
- Montclair, California, United States
- Oakland, California, United States
- Orange, California, United States
- Riverside, California, United States
- San Jose, California, United States
- Santa Ana, California, United States
- Stanford, California, United States
- Thousand Oaks, California, United States
- Upland, California, United States
- Lauderhill, Florida, United States
- Miami, Florida, United States
- Miami Lakes, Florida, United States
- Okeechobee, Florida, United States
- Orlando, Florida, United States
- Tampa, Florida, United States
+ 79 more site(s).
Compensation & support
This study's listing mentions compensation or reimbursement.
No amount is published here - ClinicalTrials.gov has no reliable field for payment or travel support. Ask the study team what's actually covered (payment for your time, travel, parking, or other study costs), and never join a trial for the compensation alone.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Gilbert, Arizona, United States; Bellflower, California, United States; Encino, California, United States; La Jolla, California, United States; Los Angeles, California, United States; Montclair, California, United States and 93 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.