[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100643822":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":38,"centralContacts":42,"locations":51,"responsibleParty":74,"collaborators":27,"id":76,"slug":77,"hasResults":78,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":84,"sex":85,"minAge":86,"maxAge":87,"enrollmentInfo":88,"targetDuration":27,"studyType":91,"phases":92,"briefSummary":95,"conditions":96,"keywords":101,"overallStatus":54,"whyStopped":27,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":115},{"fullName":5,"class":6},"Johns Hopkins University","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Psilocybin + Pimavanserin","EXPERIMENTAL","Two oral pretreatment doses of pimavanserin (34 mg each) followed by a single oral dose of psilocybin (25 mg)",[13,14],"Drug: Psilocybin","Drug: Pimavanserin",{"label":16,"type":17,"description":18,"interventionNames":19},"Psilocybin + Placebo","PLACEBO_COMPARATOR","Two oral pretreatment doses of inactive placebo followed by a single oral dose of psilocybin (25 mg)",[13,20],"Drug: Inactive Placebo",[22,28,34],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"DRUG","Psilocybin","Psilocybin, 25 mg, oral, single dose",[9,16],null,{"type":23,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Pimavanserin","Pimavanserin, 34 mg, oral, two doses",[9],[33],"Nuplazid",{"type":23,"name":35,"description":36,"armGroupLabels":37,"otherNames":27},"Inactive Placebo","Inactive placebo, oral, two doses",[16],[39],{"name":40,"affiliation":5,"role":41},"David B. Yaden, PhD","PRINCIPAL_INVESTIGATOR",[43,48],{"name":44,"role":45,"phone":46,"phoneExt":27,"email":47},"Arozo Azimi","CONTACT","410-550-0007","aazimi2@jh.edu",{"name":49,"role":45,"phone":27,"phoneExt":27,"email":50},"Mazen A. Atiq, MD","matiq3@jh.edu",[52],{"facility":53,"status":54,"city":55,"state":56,"zip":57,"country":58,"countryCode":59,"cosmosGeoPoint":60,"geoPoint":65,"contacts":66},"Johns Hopkins Center for Psychedelic and Consciousness Research","RECRUITING","Baltimore","Maryland","21224","United States","US",{"type":61,"coordinates":62},"Point",[63,64],-76.61219,39.29038,{"lat":64,"lon":63},[67,68,70,71],{"name":44,"role":45,"phone":46,"phoneExt":27,"email":47},{"name":69,"role":45,"phone":27,"phoneExt":27,"email":50},"Mazen A Atiq, MD",{"name":40,"role":41,"phone":27,"phoneExt":27,"email":27},{"name":72,"role":73,"phone":27,"phoneExt":27,"email":27},"Mazen Atiq, MD","SUB_INVESTIGATOR",{"type":75,"investigatorFullName":27,"investigatorTitle":27,"investigatorAffiliation":27,"oldNameTitle":27,"oldOrganization":27},"SPONSOR","100643822","phase-1-psilocybin-efficacy-with-or-without-pimavanserin-pretreatment-100643822",false,"NCT07610135","Psilocybin Efficacy With or Without Pimavanserin Pretreatment","PRISMatic: A Phase 1b Randomized, Double-Armed, Parallel-Group, Placebo-Controlled Trial of Psilocybin Efficacy With or Without Pimavanserin Pretreatment","PRISMatic","Inclusion Criteria:\n\n* Age 21 to 65 years old\n* Provision of written informed consent\n* Fluency in English\n* At least high school level of education\n* Right-handed\n* Agree to abstain from any psychoactive drugs on the day prior to and the day of the drug administration session as demonstrated by a negative toxicology report.\n* Agree to consume approximately the same amount of caffeine-containing beverage (e.g., coffee, tea) that he\u002Fshe consumes on a usual morning, before arriving at the research unit on the mornings of drug session days. If the participant does not routinely consume caffeinated beverages, he\u002Fshe must agree not to do so on session days.\n* Agree not to take any PRN medications on the mornings of drug sessions\n* Agree that for one week before the drug session, he\u002Fshe will refrain from taking any nonprescription medication, nutritional supplement, or herbal supplement except when approved by the study investigators. Exceptions will be evaluated by the study investigators and will include acetaminophen, non-steroidal anti-inflammatory drugs, and common doses of vitamins and minerals.\n* Female participants of childbearing potential must agree to use a highly effective method of contraception throughout the study.\n* Highly effective methods are defined as those that, when used consistently and correctly (alone or in combination), are associated with a failure rate of less than 1% per year.\n* Condoms alone are not considered highly effective.\n* Abstinence is not considered a highly effective method. However, at the investigator's discretion, abstinence may be accepted if, based on the investigator's judgment and knowledge of the participant's usual and preferred lifestyle, it can be reasonably expected to result in 100% effectiveness.\n\nExclusion Criteria:\n\n* Non-English speakers and those with language or hearing impairments\n* Left-handedness (assessed by the Edinburgh Handedness Inventory)\n* Any lifetime history of psychedelic use, including serotonergic compounds (e.g., psilocybin, LSD, mescaline, DMT, 5-MeO-DMT) and nontraditional psychedelics (e.g., MDMA, ketamine, ibogaine)\n* History of psychiatric diagnosis in adulthood (≥18 years), including, but not limited to, major depressive disorder, bipolar disorder I and II, psychotic disorders, and substance use disorder.\n* Current use of neuropsychiatric medications, including but not limited to typical\u002Fatypical antidepressants, antipsychotics, and stimulants.\n* Lifetime history of substance use disorder\n* Current (within past six months) substance use disorder of moderate or greater severity\n* Clinically significant suicidal ideation (with strong intent or means) within the past 6 months or lifetime history of suicide attempt, current suicidal ideation, or otherwise judged by a study clinician to be more than low risk for suicidality\n* Current use\u002Fpositive toxicology for illicit drugs at screening and prior to drug administration session (includes illicit, non-prescribed, or prohibited substances such as amphetamines, barbiturates, buprenorphine, benzodiazepines, cocaine, MDMA, methadone, opioids, phencyclidine (PCP), and tetrahydrocannabinol (THC))\n* Nicotine user consuming the equivalent of ≥ 10 cigarettes\u002Fday\n* Altered gastrointestinal anatomy \\[history of surgeries that promote a general intestinal malabsorption (e.g., jejunoileal bypass, jejunocolic bypass, roux-en-Y gastric bypass, vertical banded gastroplasty, gastric band, gastric stapling, sleeve gastrectomy, biliopancreatic diversion with partial gastrectomy, distal gastric bypass, duodenal switch)\\]\n* Weight \\\u003C 40kg\n* Have a first degree relative with schizophrenia or other psychotic disorders (except substance\u002Fmedication-induced or due to another medical condition), or bipolar I disorder\n* MRI contraindications (e.g., claustrophobia incompatible with MRI scanning, medical device or implant incompatible with MRI, prior history as a metal worker and\u002For certain metallic objects in the body). Must complete MRI screening form and be approved by MRI technologist before each scan.\n* Unable or unwilling to perform study procedures, or inappropriate for further study participation as determined by the PI and\u002For study clinicians",true,"ALL","21 Years","65 Years",{"count":89,"type":90},20,"ESTIMATED","INTERVENTIONAL",[93,94],"PHASE1","PHASE2","Twenty healthy adults (≥21 years old) will be enrolled to evaluate the efficacy of a single oral dose of psilocybin (25 mg) administered with or without pretreatment using oral pimavanserin (34 mg) or placebo. Outcome assessments will occur at 1 week and 1 month following psilocybin administration.\n\nThe purpose of this study is to clarify the receptor-level mechanisms underlying psilocybin's effects on mood and well-being, along with the associated neurophysiologic signatures. These mechanisms will be examined using psychometric scales, autonomic and fMRI-based neurophysiologic markers, and integrated pharmacokinetic\u002Fpharmacodynamic modeling.",[97,98,99,100],"Mood (Psychological Function)","Well Being","Mood","Healthy",[24,102,103,29,104,105],"Randomized Controlled Trial","Tryptamine","Indoles","Indole Alkaloid","2026-07-20",{"date":108,"type":109},"2026-07-21","ACTUAL",{"date":111,"type":90},"2026-07",{"date":113,"type":90},"2028-12",{"name":5,"class":6},1]