Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
Phase 2: testing Psilocybin 25 mg for Treatment Resistant Depression
Psilocybin, the chemical component of "magic mushrooms", has been administered with psychotherapy in several randomly assigned clinical trials (RCTs) showing large and sustained antidepressant effects. In healthy volunteers, the psychedelic effects of psilocybin have been shown to be blocked by administration of certain medications such as risperidone.
Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are Psilocybin 25 mg, or Risperidone 1 MG. The registry lists allocation as randomized. Psilocybin, the chemical component of "magic mushrooms", has been administered with psychotherapy in several randomly assigned clinical trials (RCTs) showing large and sustained antidepressant effects.
They plan to enroll about 12 people at Toronto. Taking part typically means taking a study drug (or dummy pill) plus check-ins.
Official title (unrewritten)
Imaging the Effects of Serotonin 2A Receptor Modulation on Synaptic Density in Treatment-resistant Depression (SYNVEST)
Primary outcome (registry wording): Feasibility of obtaining PET imaging scans before and after administration of psilocybin (25 mg) with and without risperidone (1 mg) in adults with TRD.
Who it is for (from inclusion criteria)
Ages 18 Years to 65 Years
Adults 18 to 65 years old;
Stated willingness to comply with all study procedures;
Ability to read and communicate in English, such that their literacy and comprehension is sufficient for understanding the consent form and study questionnaires, as evaluated by study staff obtaining consent;
Primary DSM-5 diagnosis of non-psychotic major depression, single or recurrent, based on the Structured Clinical Interview for DSM-5 (SCID-5) administered at the first screening visit;
Ability to take oral medication;
Individuals who are capable of becoming pregnant: use of highly effective contraception for at least 3 months prior to screening and agreement to use such a method during study participation;
Individuals who are willing to taper off current antidepressant and antipsychotic medications for a minimum of 2-weeks (or more depending on the medication) prior to Baseline (V2) and whose physician confirms that it is safe for them to do so; and
Who the registry excludes
Pregnant as assessed by a urine pregnancy test at Screening (V1) or individual's that intend to become pregnant during the study or are breastfeeding;
Treatment with another investigational drug or other intervention within 30 days of Screening (V1);
Have initiated psychotherapy in the preceding 12 weeks prior to Screening (V1);
Have a DSM-5 diagnosis of substance use disorder (use of tobacco is permitted) within the preceding 6 months;
Have active suicidal ideation with intent and plan as determined by item 3 of the HamD-17;
Any first-degree relative with a diagnosis of schizophrenia-spectrum disorder; psychotic disorder (unless substance-induced or due to a medical condition); or bipolar I disorder as determined by the family medical history form and discussions with the participant;
Presence of baseline prolonged QTc or Torsade de Pointes as measured by the ECG or a history of long QTc syndrome or related risk factors;
We will investigate the clinical manifestations and molecular genetic defects of heritable urologic malignant disorders. Families with urologic malignancy with known or suspected genetic basis will be enrolled.
This protocol will evaluate patients with systemic lupus erythematosus (SLE) and their relatives to learn more about how the disease develops and changes over time. It will also study genetic factors that make a person susceptible to SLE.
This study is designed to explore the genetics and pathophysiology of diseases presenting with intermittent fever, including familial Mediterranean fever, TRAPS, hyper-IgD syndrome, and related diseases. The following individuals may be eligible for this natural history study: 1) patients with known or suspected familial Mediterranean fever, TRAPS, hyper-IgD syndrome or related disorders; 2) relatives of these patients; 3) healthy, normal volunteers 7 years of age or older.
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT06512220?
Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT06512220?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.