Depressive Disorder study: Psilocybin
Official title A Randomized Neuroimaging Trial of Psilocybin in Depression
ClinicalTrials.gov ID: NCT06072898
What this study is testing
What is Psilocybin?
This is an investigational oral medication being studied to see if it changes brain activity in people with depressive disorder. It is designed to interact with serotonin receptors in the brain to alter neural connectivity and blood flow in areas linked to mood.
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
- The study wants to see if psilocybin changes how brain networks that control mood work, compared to a placebo.
- Who it's for
- Adults who have a depressive disorder, such as major depressive disorder.
- What's involved
- Participants will have two visits. On each visit they will take a pill (either psilocybin or a placebo) and then have an MRI scan before receiving supportive therapy. The visits are spaced so that some people get placebo first and psilocybin second, while others get psilocybin both times.
- Time commitment
- The study lasts about a month, with two visits that include a pill, an MRI scan, and therapy sessions.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, 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 to 64
You may be able to join if
- Able and voluntarily willing to provide written informed consent at the screening visit
- Over 18 and under 65 years old
- Able to complete all protocol required assessment tools without any assistance or alteration to the copyrighted assessments, and to comply with all...
- Must have a responsible individual/caregiver who is able to monitor the participant at home for 24 hours after each treatment visit in the study
- Must have a psychiatrist and/or general practitioner who is able to provide psychiatric follow-up care
You likely can't join if
- Current or past history of bipolar I/II disorder, schizophrenia, schizoaffective disorder, psychotic disorder, or delusional disorder as assessed by...
- A clinical diagnosis of antisocial personality disorder and/or paranoid personality disorder (defined as meeting DSM-5 criteria) based on clinical...
- An active clinical diagnosis of borderline personality disorder as confirmed by the MINI 7.0.
- Depression secondary to other medical conditions or bipolar I and II disorder
- Family history of a first degree relative with a diagnosis of schizophrenia or a primary psychotic disorder and/or bipolar disorder
- Any symptoms consistent with psychosis
See the full eligibility criteria
- Able and voluntarily willing to provide written informed consent at the screening visit
- Over 18 and under 65 years old
- Able to complete all protocol required assessment tools without any assistance or alteration to the copyrighted assessments, and to comply with all study visits
- Must have a responsible individual/caregiver who is able to monitor the participant at home for 24 hours after each treatment visit in the study
- Must have a psychiatrist and/or general practitioner who is able to provide psychiatric follow-up care
- Have a Mini-International Neuropsychiatric Interview (MINI) confirmed diagnosis of MDD, recurrent or single episode without psychotic features where the duration of the current episode is at least 3 months
- Depression of at least moderate severity as defined by a Hamilton Depression Rating Scale (HAMD-17) score \>17
- Current or past history of bipolar I/II disorder, schizophrenia, schizoaffective disorder, psychotic disorder, or delusional disorder as assessed by a structured clinical interview (MINI)
- A clinical diagnosis of antisocial personality disorder and/or paranoid personality disorder (defined as meeting DSM-5 criteria) based on clinical interview and the MINI 7.0.
- An active clinical diagnosis of borderline personality disorder as confirmed by the MINI 7.0.
- Depression secondary to other medical conditions or bipolar I and II disorder
- Family history of a first degree relative with a diagnosis of schizophrenia or a primary psychotic disorder and/or bipolar disorder
- Any symptoms consistent with psychosis
- Any symptoms consistent with hypomania and/or mania as assessed by a psychiatrist
- Personal history of ≥ 1 suicide attempt in the past year requiring hospitalization, defined using the Columbia Suicide Severity Rating Scale (CSSRS) (Q6 (past year) = "y") and clinical interview with a psychiatrist
- Other personal circumstances or behavior judged to be incompatible with establishment of rapport or safe exposure to psilocybin
- Women who are pregnant (self-report or via urine test), nursing, or planning a pregnancy
- Lifetime history of substance use disorder with a hallucinogen
- Lifetime history of substance-induced psychosis
- Positive urine drug screen for illicit drugs or drugs of abuse at screening, a week prior to treatment, and during the trial (any positive urine drug test will be reviewed with participants to determine the pattern of...
- Abnormal and clinically significant results on a physical examination performed within one month of study participation by a general practitioner, vital signs, ECG, or laboratory test at screening
- QTc prolongation on ECG
- Uncontrolled or insulin-dependent diabetes
- History of seizure disorder except for seizures from electroconvulsive therapy and/or febrile seizures in childhood
- Diagnosis of any mild or major neurocognitive disorder meeting DSM-5 criteria and based on clinical interview/cognitive screening by a psychiatrist
- History of stroke, recent myocardial infarction (\ 140/90 mmHg) or clinically significant arrhythmia within 1 year of signing the ICF
- Any other clinically significant cardiovascular, pulmonary, gastrointestinal, hepatic, renal or any other major concurrent illness that, in the opinion of the investigator, may interfere with the interpretation of the...
- Exposure to psilocybin or any other psychedelic in the past 12 months prior to screening and/or during the current MDE and use of psychedelics, such as ayahuasca/LSD, during the current depressive episode
- History of substance use and/or alcohol use disorder, of moderate severity or greater, in the past 12 months
- Current enrolment in an treatment study for depression or participation in such within 30 days of screening
- Serial blood counts to achieve a value to meet eligibility - abnormalities in screening/baseline blood work (complete blood counts, electrolyte panel, etc.) will be reviewed by MD, then repeated serially until...
The study team makes the final eligibility decision.
Where it is enrolling
- Toronto, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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, but 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 to 64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Toronto, Ontario, Canada. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.