[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100575181":3},{"organization":4,"outcomesModule":7,"designInfo":42,"detailedDescription":52,"studyPopulation":41,"armGroups":53,"interventions":74,"overallOfficials":99,"centralContacts":103,"locations":109,"responsibleParty":127,"collaborators":41,"id":129,"slug":41,"hasResults":130,"nctId":131,"briefTitle":132,"officialTitle":133,"acronym":134,"eligibilityCriteria":135,"healthyVolunteers":136,"sex":137,"minAge":138,"maxAge":139,"enrollmentInfo":140,"targetDuration":41,"studyType":143,"phases":144,"briefSummary":146,"conditions":147,"keywords":149,"overallStatus":111,"whyStopped":41,"lastUpdateSubmitDate":157,"lastUpdatePostDateStruct":158,"startDateStruct":161,"completionDateStruct":163,"leadSponsor":165,"locationsCount":166},{"fullName":5,"class":6},"University of Calgary","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":41},[9],{"measure":10,"description":11,"timeFrame":12},"Positive effects","Persisting Effects Questionnaire (PEQ) - 145 questions rated using a 6-point Likert scale from 0 to 6. There are 12 sub-scale themes assessing positive and negative changes in Attitudes About Life, Attitudes About Self, Mood Changes, Social Effects, Behavioural Changes, and Spirituality. Higher scores in the positive sub-scales indicate a better outcome, while higher scores in the negative sub-scales indicate a worse outcome.","One week and one month post-dosing",[14,18,22,26,29,32,35,38],{"measure":15,"description":16,"timeFrame":17},"Stress reactivity","Stress reactivity will be assessed through heart rate variability","From start of dosing session to end of dosing session",{"measure":19,"description":20,"timeFrame":21},"Biomarkers of stress and plasticity","cortisol, ACTH, BDNF","from baseline to dosing session (one week post-baseline) to follow-up 1 (one week post doing session) to follow-up 2 (one month post dosing session)",{"measure":23,"description":24,"timeFrame":25},"Mood","Mood will be assessed using the Positive and Negative Affect Schedule. The questionnaire has two sub-scales: the positive affect score (scores range from 10-50, higher scores represent better outcome) and the negative affect score (scores range from 10-50, higher scores represent worse outcome)","from baseline to one week and one month post-dosing",{"measure":27,"description":28,"timeFrame":25},"Well-being","Well-being will be assessed using the Warwick-Edinburgh Mental Wellbeing Scale. The total score ranges from 14-70; a higher score represents a better outcome.",{"measure":30,"description":31,"timeFrame":25},"Anxiety","Anxiety will be measured using the State-Trait Anxiety Inventory. The total score ranges from 20-80; a higher score represents a worse outcome.",{"measure":33,"description":34,"timeFrame":25},"Cognitive Flexibility","The Berg Card Sorting Task is a set-shifting measure of cognitive flexibility modeled after the Wisconsin Card Sorting task. Participants must select the stimulus that is different from others based on feedback and adapt their responses once the criteria for correct choice switches. Perseverative errors are defined as the number of instances in which three incorrect responses are made based on a previous rule, and they are thought to reflect less cognitive flexibility (or cognitive rigidity).",{"measure":36,"description":37,"timeFrame":25},"Spontaneous Thought","To measure spontaneous thought, participants will complete a Think Aloud task where they narrate their stream of thought in real time.",{"measure":39,"description":40,"timeFrame":25},"Reinforcement Learning","Reinforcement learning will be assessed using a three-armed bandit task. This is a decision-making task in which participants must choose between three alternative targets whose values (probability of reward) changes over the trials.",null,{"allocation":43,"interventionModel":44,"interventionModelDescription":41,"primaryPurpose":6,"observationalModel":41,"timePerspective":41,"maskingInfo":45},"RANDOMIZED","FACTORIAL",{"masking":46,"maskingDescription":41,"whoMasked":47},"QUADRUPLE",[48,49,50,51],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR","The overall goal of this clinical trial is to systematically explore the relationship between the subjective psychedelic experience, improvements in well-being, and the stress response following psilocybin administration.\n\nThe investigators aim to determine whether blocking the acute subjective effects (via risperidone) will influence the acute or protracted effects of psilocybin as measured via self-report, biochemical, or psychophysiological measures. The study also aims to determine if individual variability in stress reactivity or regulation predicts acute (day of dosing) or protracted (1-week later) effects of psilocybin.\n\nA single site will recruit 128 participants aged 18 to 65 who do not meet criteria for any psychiatric diagnoses. A series of questionnaires, blood labs, and medical exams including electrocardiogram will determine inclusion into the study. Once accepted into the study, participants will complete baseline measures assessing biomarkers such as cortisol and brain-derived neurotrophic factor (BDNF) levels, cognitive flexibility, mood, well-being, personality traits, and anxiety levels.\n\nParticipants will then be randomly assigned into one of the following groups:\n\ni) high dose psilocybin in combination with placebo pretreatment ii) high dose psilocybin in combination with risperidone pretreatment iii) low dose psilocybin in combination with placebo pretreatment iv) low dose psilocybin in combination with risperidone pretreatment\n\nOutcome measures will be assessed at 1-week and 1-month after each dosing session.",[54,61,65,71],{"label":55,"type":56,"description":57,"interventionNames":58},"High-dose psilocybin + placebo","ACTIVE_COMPARATOR","placebo + psilocybin (+60 min)",[59,60],"Drug: Psilocybin high-dose","Drug: Placebo",{"label":62,"type":56,"description":57,"interventionNames":63},"Low-dose psilocybin + placebo",[64,60],"Drug: Psilocybin low-dose",{"label":66,"type":67,"description":68,"interventionNames":69},"High-dose psilocybin + risperidone","EXPERIMENTAL","risperidone + psilocybin (+60 min)",[59,70],"Drug: Risperidone 1 MG",{"label":72,"type":56,"description":68,"interventionNames":73},"Low-dose psilocybin + risperidone",[64,70],[75,83,89,95],{"type":76,"name":77,"description":78,"armGroupLabels":79,"otherNames":80},"DRUG","Psilocybin high-dose","The drug product (DP) PEX010 is a capsule for oral administration and is manufactured with DS PYEX (12.5-14.0% psilocybin), excipients, and HPMC capsules. The product is manufactured in two product strengths, and this represents the high-dose",[55,66],[81,82],"PEX010","high-dose psilocybin",{"type":76,"name":84,"description":85,"armGroupLabels":86,"otherNames":87},"Psilocybin low-dose","The drug product (DP) PEX010 is a capsule for oral administration and is manufactured with DS PYEX (12.5-14.0% psilocybin), excipients, and HPMC capsules. The product is manufactured in two product strengths, and this represents the low-dose.",[62,72],[81,88],"low-dose psilocybin",{"type":76,"name":90,"description":91,"armGroupLabels":92,"otherNames":93},"Risperidone 1 MG","risperidone 1mg capsules",[66,72],[94],"Risperdal",{"type":76,"name":96,"description":97,"armGroupLabels":98,"otherNames":41},"Placebo","inactive placebo",[55,62],[100],{"name":101,"affiliation":5,"role":102},"Leah Mayo, PhD","PRINCIPAL_INVESTIGATOR",[104],{"name":105,"role":106,"phone":107,"phoneExt":41,"email":108},"Ana Deutsch, MSc","CONTACT","587-893-0257","ana.deutsch@ucalgary.ca",[110],{"facility":5,"status":111,"city":112,"state":113,"zip":114,"country":115,"countryCode":116,"cosmosGeoPoint":117,"geoPoint":122,"contacts":123},"RECRUITING","Calgary","Alberta","T2N 4N1","Canada","CA",{"type":118,"coordinates":119},"Point",[120,121],-114.08529,51.05011,{"lat":121,"lon":120},[124,126],{"name":105,"role":106,"phone":107,"phoneExt":41,"email":125},"pactlab@ucalgary.ca",{"name":101,"role":102,"phone":41,"phoneExt":41,"email":41},{"type":128,"investigatorFullName":41,"investigatorTitle":41,"investigatorAffiliation":41,"oldNameTitle":41,"oldOrganization":41},"SPONSOR","100575181",false,"NCT06768944","Subjective Experience Following Psilocybin","The Role of the Subjective Experience in Supporting Positive Effects Following Psilocybin: a Randomized, Controlled Clinical Trial Using Risperidone in Healthy Adults","SEP-1","Inclusion Criteria:\n\n* Individuals of all sexes, gender identities, and ethnicities\n* Ages 18 to 65 years of age at the time of screening\n* Ability to read\u002Fwrite in English\n* Agree not to consume psychoactive drugs 24 hours before dosing sessions or consume psychedelics during duration of study participation\n\nExclusion Criteria:\n\n* Any notable abnormality on electrocardiogram or routine medical blood or urinalysis laboratory tests\n* Current psychiatric diagnoses, such as: major depressive disorder, generalized anxiety disorder, panic disorder, social anxiety disorder, obsessive compulsive disorder, moderate to severe substance use disorders, eating disorders, personality disorders, post-traumatic stress disorder\n* Lifetime or current psychiatric diagnoses of: psychosis, schizophrenia, bipolar disorder\n* Family history: a first- or second degree relative with a history of schizophrenia or other psychotic disorders, bipolar I or II\n* Medication: Any medication with the potential to interact with the investigational medicinal products, especially those with serotonergic mechanisms of actions like SSRIs, SNRIs or MAO-Inhibitors as well as other antipsychotics\n* Currently pregnancy or nursing, trying to become pregnant, or unwilling to use acceptable method of contraception during the study\n* Current or recent (within 12 weeks) participation in a clinical trial involving medication administration\n* Cognitive impairment (Folsetin Mini Mental State Exam score \\\u003C 24)\n* A disorder that may interfere with drug absorption, distribution, metabolism, or excretion (including gastrointestinal surgery).\n* Suffered a traumatic brain injury with one of the following symptoms Loss of consciousness \\>30min Alteration of consciousness\u002Fmental state \\>24h Post-traumatic amnesia \\>1 day Glasgow Coma Scale (best available score in first 24 hours) \\\u003C13\n* Any other circumstances that, in the opinion of the investigators, compromises participant safety",true,"ALL","18 Years","65 Years",{"count":141,"type":142},128,"ESTIMATED","INTERVENTIONAL",[145],"PHASE2","The purpose of this study is to determine the importance of the acute subjective experience induced by psilocybin (the primary component of \"magic mushrooms\") in facilitating positive outcomes. Participants in this study will be given psilocybin in combination with either a placebo or risperidone, an atypical antipsychotic that block the subjective effects of psilocybin.",[148],"Investigating the Importance of the Subjective Psychedelic Experience",[150,151,152,153,154,155,156],"psychedelics","psilocybin","stress response","cortisol","healthy participants","risperidone","subjective effects","2026-05-29",{"date":159,"type":160},"2026-06-02","ACTUAL",{"date":162,"type":160},"2026-05-15",{"date":164,"type":142},"2028-01",{"name":5,"class":6},1]