[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100599087":3},{"organization":4,"outcomesModule":7,"designInfo":47,"detailedDescription":54,"studyPopulation":46,"armGroups":55,"interventions":86,"overallOfficials":46,"centralContacts":196,"locations":202,"responsibleParty":222,"collaborators":46,"id":224,"slug":46,"hasResults":225,"nctId":226,"briefTitle":227,"officialTitle":227,"acronym":46,"eligibilityCriteria":228,"healthyVolunteers":229,"sex":230,"minAge":231,"maxAge":232,"enrollmentInfo":233,"targetDuration":46,"studyType":236,"phases":237,"briefSummary":239,"conditions":240,"keywords":242,"overallStatus":205,"whyStopped":46,"lastUpdateSubmitDate":244,"lastUpdatePostDateStruct":245,"startDateStruct":248,"completionDateStruct":250,"leadSponsor":252,"locationsCount":253},{"fullName":5,"class":6},"Hadassah Medical Organization","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":46},[9],{"measure":10,"description":11,"timeFrame":12},"Incidence and severity of treatment-emergent adverse events (TEAEs) following administration of psilocybin and D-serine","The number, type, severity, timing, and relatedness of treatment-emergent adverse events following administration of psilocybin and D-serine. Adverse events will be assessed through continuous clinical monitoring, spontaneous reports, and structured instruments including the UKU Side Effect Rating Scale. Safety will also be evaluated via changes in vital signs, ECG, and laboratory tests (SMAC-20, CBC, urinalysis). Events will be classified using standard regulatory definitions and graded for severity and relatedness to study treatment.","From time of dosing (Day 1) through Day 84 (final follow-up visit)",[14,18,22,26,30,33,36,39,43],{"measure":15,"description":16,"timeFrame":17},"Change in subjective psychedelic experience measured by the 5D-ASC scale","Assessment of subjective altered states of consciousness using the 5-Dimensional Altered States of Consciousness scale.\n\nFull questionnaire consists of 94 items, each item reflects a subjective experience during the altered state.\n\nEach rated on a visual analog scale from 0 to 100, where:\n\n0 = \"not at all\" 100 = \"extremely\"\n\nThe items are grouped into 5 empirically derived dimensions, each representing a core aspect of altered consciousness:\n\nOceanic Boundlessness- Positively experienced ego dissolution, unity, bliss High scores = mystical-type experiences Anxious Ego Dissolution- Anxiety, loss of ego control, cognitive impairment High scores = difficult or fearful experiences Visionary Restructuralization -Visual imagery, hallucinations, synesthesia High scores = complex visual phenomena Auditory Alterations - Changes in auditory perception, e.g., hearing sounds or voices Reduction of Vigilance- Reduced alertness or drowsiness (less relevant in classic psychedelic states)","6 hours post-dosing and Day 2 follow-up",{"measure":19,"description":20,"timeFrame":21},"Change in mood states assessed by the Profile of Mood States (POMS)","Change in emotional and mood states as measured by the POMS scale. Participants complete the questionnaire at multiple time points to evaluate transient mood fluctuations in response to treatment.\n\nThe administered version of the POMS questionnaire consists of 28 adjectives describing various feelings and emotions, and participants rate the extent to which they have experienced each over a specified period (e.g., the past week), typically using a 5-point Likert scale ranging from 0 (\"not at all\") to 4 (\"extremely\").","Baseline, 8 and 20 hours post-dosing, Day 2, Week 1, and Day 84",{"measure":23,"description":24,"timeFrame":25},"Change in anxiety and stress measured by the Subjective Units of Distress Scale (SUDS)","Subjective assessment of distress and anxiety using the SUDS, a self-report scale ranging from 0 (no distress) to 100 (extreme distress). Assessed multiple times to track acute and residual anxiety responses.","Baseline, 8 and 20 hours post-dosing, Day 2",{"measure":27,"description":28,"timeFrame":29},"Change in plasma D-serine concentration","Measurement of plasma D-serine (in micromoles per liter (µmol\u002FL)) to explore potential neurobiological correlates of treatment. Blood collected at baseline and follow-up.","Baseline and Week 1 (Day 7)",{"measure":31,"description":32,"timeFrame":29},"Change in plasma inflammatory markers concentration.","Measurement of plasma inflammatory markers to explore potential neurobiological correlates of treatment. Blood collected at baseline and follow-up.",{"measure":34,"description":35,"timeFrame":29},"Change in plasma BDNF concentration","Measurement of plasma PLASMA Brain-Derived Neurotrophic Factor (in micromoles per picograms per milliliter (pg\u002FmL)) to explore potential neurobiological correlates of treatment. Blood collected at baseline and follow-up.",{"measure":37,"description":38,"timeFrame":29},"Change in plasma glutamate concentration","Measurement of plasma glutamate (in micromoles per liter (µmol\u002FL)) to explore potential neurobiological correlates of treatment. Blood collected at baseline and follow-up.",{"measure":40,"description":41,"timeFrame":42},"Beck Depression Inventory-II (BDI-II) total score","Self-reported symptoms of depression will be assessed using the 21-item Beck Depression Inventory-II, which provides a standardized index of depressive severity.\n\nEach corresponding to a symptom of depression, rated on a scale from 0 to 3 based on intensity. The total score ranges from 0 to 63, with higher scores indicating more severe depressive symptoms. Score interpretation is as follows: 0-13 = minimal depression, 14-19 = mild depression, 20-28 = moderate depression, and 29-63 = severe depression.","Baseline (Day -1), Day 2, Day 7, and Day 84",{"measure":44,"description":45,"timeFrame":42},"State-Trait Anxiety Inventory (STAI) - State and Trait scores","Anxiety symptoms will be measured using the STAI, which provides separate scores for State Anxiety (how participants feel in the moment) and Trait Anxiety (how they generally feel).\n\nThe STAI consists of 40 items - 20 assessing state anxiety and 20 assessing trait anxiety - each rated on a 4-point Likert scale. Scores for each subscale range from 20 to 80, with higher scores indicating greater levels of anxiety. Generally, a score of 20-37 suggests low anxiety, 38-44 moderate anxiety, and 45-80 high anxiety.",null,{"allocation":48,"interventionModel":49,"interventionModelDescription":50,"primaryPurpose":51,"observationalModel":46,"timePerspective":46,"maskingInfo":52},"NON_RANDOMIZED","SEQUENTIAL","The study will include 2 cohorts:\n\nFirst cohort of 5 participants will be recruited and administered a single dose of 15 mg of Psilocybin and 5 gr of D-Serine. Safety data will be collected, and an interim safety report will be submitted to the Ethics Committee (EC).\n\nFollowing administration to the initial cohort, safety and tolerability will be evaluated, and if no significant concerns are identified, the second cohort will be enrolled to receive a higher dose in order to determine the optimal dosage\n\nThe second cohort of 5 participants will receive an increased one time dose of 25 mg of Psilocybin and 7 gr of D-Serine to determine the effective dose.\n\nThe following visits will be conducted for both cohorts: Screening, Preparation, Administration (Day 1), and follow-up visits on Day 2, Day 7, Day 28, and Day 84.","TREATMENT",{"masking":53,"maskingDescription":46,"whoMasked":46},"NONE","This is a first-in-human, Phase I, exploratory clinical trial designed to evaluate the safety, tolerability, and initial psychological and physiological responses to a single administration of psilocybin in combination with D-Serine in healthy adult volunteers. The rationale for this combination stems from preclinical evidence indicating that D-Serine, a naturally occurring co-agonist at the NMDA receptor, may attenuate the acute psychedelic effects of psilocybin while preserving its neuroplastic and therapeutic properties.\n\nPreclinical studies demonstrated that D-Serine reduced the psilocybin-induced head-twitch response (HTR) in rodent models and enhanced the expression of synaptic plasticity markers (e.g., GAP43, PSD95, SV2A, synaptophysin) across multiple brain regions, with effects sustained up to 12 days post-treatment. These findings suggest that the combination may improve the safety and tolerability of psilocybin, particularly for populations sensitive to its psychoactive effects.\n\nThe trial will consist of four sequential components:\n\nScreening Phase - to assess eligibility.\n\nPreparation Phase - to establish therapeutic rapport and baseline assessments.\n\nAdministration Phase - involving a single oral administration of the investigational combination (psilocybin + D-Serine).\n\nFollow-up Phase - including in-person follow-up visits on Day 2, Day 7, Day 28, and Day 84 post-treatment to monitor safety outcomes, subjective responses, and potential delayed effects.",[56,82],{"label":57,"type":58,"description":59,"interventionNames":60},"15 mg of Psilocybin and 5 gr of D-Serine","EXPERIMENTAL","The investigational drug, 15 mg of Psilocybin and 5 g of D-Serine, will be administered as a single oral dose in solution form.",[61,62,63,64,65,66,67,68,69,70,71,72,73,74,75,76,77,78,79,80,81],"Drug: Psilocybin and D-Serine","Diagnostic Test: Physical Examination","Diagnostic Test: Vital signs","Diagnostic Test: ECG test","Diagnostic Test: Comprehensive Blood Panel","Diagnostic Test: Complete Blood Count","Diagnostic Test: Urinalysis","Diagnostic Test: Urine Toxicology Screen","Diagnostic Test: A pregnancy Urine test","Diagnostic Test: Electroencephalogram","Diagnostic Test: Plasma Amino Acid Levels","Diagnostic Test: Plasma Inflammation Markers","Diagnostic Test: Plasma Brain-Derived Neurotrophic Facto","Other: Mini International Neuropsychiatric Interview","Other: Family Psychiatric History Assessment","Other: Beck Depression Inventory","Other: State-Trait Anxiety Inventory","Behavioral: Profile of Mood States","Behavioral: Subjective Units of Distress Scale","Other: Five-Dimensional Altered States of Consciousness questionnaire","Behavioral: Integration",{"label":83,"type":58,"description":84,"interventionNames":85},"25 mg of Psilocybin and 7 gr of D-Serine","The investigational drug, 25 mg of Psilocybin and 7 g of D-Serine, will be administered as a single oral dose in solution form.",[61,62,63,64,65,66,67,68,69,70,71,72,73,74,75,76,77,78,79,80,81],[87,92,97,101,105,111,117,121,125,129,135,139,143,149,155,161,167,173,180,186,192],{"type":88,"name":89,"description":90,"armGroupLabels":91,"otherNames":46},"DRUG","Psilocybin and D-Serine","A single administration of the drug, with dosage divided as follows:\n\nCohort 1: 15 mg of Psilocybin and 5 gr of D-Serine Cohort 2: 25 mg of Psilocybin and 7 gr of D-Serine",[57,83],{"type":93,"name":94,"description":95,"armGroupLabels":96,"otherNames":46},"DIAGNOSTIC_TEST","Physical Examination","The physical examination will include diagnosis and documentation of any significant clinical abnormalities or diseases. It will be performed during the baseline rating visit (preparation phase).",[57,83],{"type":93,"name":98,"description":99,"armGroupLabels":100,"otherNames":46},"Vital signs","Vital sign measurements (blood pressure, pulse, and oxygen saturation) will be taken at screening, preparation, baseline rating, administration day, day 2, day 28, and day 84.\n\nVital signs will be assessed at the following time points on the administration day and on day 2: pre-administration, and at 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, and 24 hours post-administration.",[57,83],{"type":93,"name":102,"description":103,"armGroupLabels":104,"otherNames":46},"ECG test","A 12-lead ECG will be performed to rule out underlying cardiac abnormalities. An ECG will be conducted for each patient during the screening and Day 2 visits.",[57,83],{"type":93,"name":106,"description":107,"armGroupLabels":108,"otherNames":109},"Comprehensive Blood Panel","A comprehensive blood panel will be performed to assess kidney and liver function, electrolyte balance, and glucose levels.\n\nIt will be conducted during the Screening visit, and on Day 2, Day 28, and Day 84.",[57,83],[110],"SMAC-20",{"type":93,"name":112,"description":113,"armGroupLabels":114,"otherNames":115},"Complete Blood Count","Complete Blood Count will be performed to check for hematological abnormalities.\n\nIt will be conducted during the Screening visit, and on Day 2, Day 28, and Day 84.",[57,83],[116],"CBC",{"type":93,"name":118,"description":119,"armGroupLabels":120,"otherNames":46},"Urinalysis","Urinalysis will be conducted during the Screening visit, and on Day 2, Day 28, and Day 84.",[57,83],{"type":93,"name":122,"description":123,"armGroupLabels":124,"otherNames":46},"Urine Toxicology Screen","Urine Toxicology Screen will be performed to rule out illicit drug use. It will be conducted during the Screening visit, and on Day 2, Day 28, and Day 84.",[57,83],{"type":93,"name":126,"description":127,"armGroupLabels":128,"otherNames":46},"A pregnancy Urine test","A urine pregnancy test will be performed for women of childbearing potential only. It will be conducted during the screening and baseline rating visits. If the urine test is positive, a serum β-hCG test will be performed for confirmation.",[57,83],{"type":93,"name":130,"description":131,"armGroupLabels":132,"otherNames":133},"Electroencephalogram","EEG will be performed during the baseline rating scale and Day 7 visits to evaluate brain activity",[57,83],[134],"EEG",{"type":93,"name":136,"description":137,"armGroupLabels":138,"otherNames":46},"Plasma Amino Acid Levels","The following blood test parameters - D-Serine, L-Serine, and Glycine - will be assessed during the Screening and Day 28 visits.",[57,83],{"type":93,"name":140,"description":141,"armGroupLabels":142,"otherNames":46},"Plasma Inflammation Markers","The following blood test parameters - Tumor Necrosis Factor Alpha (TNF-α), Interleukin-6 (IL-6), and C-Reactive Protein (CRP) - will be assessed during the Screening and Day 28 visits.",[57,83],{"type":93,"name":144,"description":145,"armGroupLabels":146,"otherNames":147},"Plasma Brain-Derived Neurotrophic Facto","Plasma BDNF (Brain-Derived Neurotrophic Factor) levels will be measured during the screening and Day 28 visits.",[57,83],[148],"Plasma BDNF",{"type":6,"name":150,"description":151,"armGroupLabels":152,"otherNames":153},"Mini International Neuropsychiatric Interview","The Mini International Neuropsychiatric Interview (MINI) will be administered during the screening visit to rule out any current or past major psychiatric disorders.",[57,83],[154],"MINI",{"type":6,"name":156,"description":157,"armGroupLabels":158,"otherNames":159},"Family Psychiatric History Assessment","The Family Psychiatric History Assessment (FPHA) will be administered during the screening visit to help rule out any current or past major psychiatric disorders.",[57,83],[160],"FPHA",{"type":6,"name":162,"description":163,"armGroupLabels":164,"otherNames":165},"Beck Depression Inventory","The Beck Depression Inventory (BDI) will be administered at the following visits: screening, baseline, day 7, day 28, and day 84. It will be used to assess baseline mood and to rule out depressive symptoms.",[57,83],[166],"BDI",{"type":6,"name":168,"description":169,"armGroupLabels":170,"otherNames":171},"State-Trait Anxiety Inventory","State-Trait Anxiety Inventory (STAI) will be administered at the following visits: screening, baseline, day 7, day 28, and day 84. It will be used to screen for anxiety disorders.",[57,83],[172],"STAI",{"type":174,"name":175,"description":176,"armGroupLabels":177,"otherNames":178},"BEHAVIORAL","Profile of Mood States","The Profile of Mood States (POMS) will be administered to assess baseline mood and emotional state.\n\nIt will be administered at the following visits: screening, baseline, administration day, day 2, day 7, day 28, and day 84.\n\nOn the administration day and on day 2, it will be administered at the following time points: pre-administration, and 8 and 20 hours post-administration.",[57,83],[179],"POMS",{"type":174,"name":181,"description":182,"armGroupLabels":183,"otherNames":184},"Subjective Units of Distress Scale","Subjective Units of Distress Scale (SUDS) will be administered to assess anxiety and stress levels.\n\nIt will be administered at the following visits: screening, baseline, administration day, day 2, day 7, day 28, and day 84.\n\nOn the administration day and on day 2, it will be administered at the following time points: pre-administration, and 8 and 20 hours post-administration.",[57,83],[185],"SUDS",{"type":6,"name":187,"description":188,"armGroupLabels":189,"otherNames":190},"Five-Dimensional Altered States of Consciousness questionnaire","The Five-Dimensional Altered States of Consciousness questionnaire (5D-ASC) will be used to assess the acute subjective psychedelic experience. It will be administered after the acute effects have subsided - at 6.0 hours post-administration on the administration day, and again on day 2 - to evaluate five key experiential dimensions: visual restructuralization, oceanic boundlessness, reduction of vigilance, anxious ego dissolution, and auditory alterations. Each item will be rated using a Visual Analogue Scale (VAS) ranging from \"NO, not more than usually\" (0 mm) to \"YES, much more than usually\" (100 mm).",[57,83],[191],"5D-ASC",{"type":174,"name":193,"description":194,"armGroupLabels":195,"otherNames":46},"Integration","The integration process is conducted to support participants in processing and incorporating their therapeutic experience into daily life, with the aim of enhancing emotional insight and psychological well-being. Integration will take place at the following visits: 8.0 hours post-treatment on the administration day, day 2, day 7, day 28, and day 84.",[57,83],[197],{"name":198,"role":199,"phone":200,"phoneExt":46,"email":201},"Bernard Lerer, MD","CONTACT","+972-50-7874575","lerer@mail.huji.ac.il",[203],{"facility":204,"status":205,"city":206,"state":46,"zip":46,"country":207,"countryCode":208,"cosmosGeoPoint":209,"geoPoint":214,"contacts":215},"Hadassah Medical Organization, Jerusalem, Israel","RECRUITING","Jerusalem","Israel","IL",{"type":210,"coordinates":211},"Point",[212,213],35.21633,31.76904,{"lat":213,"lon":212},[216,220],{"name":217,"role":199,"phone":218,"phoneExt":46,"email":219},"Hadas Lemberg, PhD","00 972 2 6777572","lhadas@hadassah.org.il",{"name":198,"role":221,"phone":46,"phoneExt":46,"email":46},"PRINCIPAL_INVESTIGATOR",{"type":223,"investigatorFullName":46,"investigatorTitle":46,"investigatorAffiliation":46,"oldNameTitle":46,"oldOrganization":46},"SPONSOR","100599087",false,"NCT07079930","Safety and Psychological Effects of Psilocybin and D-Serine Formulation in Healthy Volunteers","Inclusion Criteria:\n\n1. Aged 25-60 years, male or female.\n2. Medically healthy, as confirmed by a comprehensive clinical assessment.\n3. Written informed consent provided.\n\nExclusion Criteria:\n\n1. History of any Axis 1 psychiatric disorder requiring pharmacotherapy such as schizophrenia, schizoaffective disorder, any other psychotic disorder, bipolar disorder, as well as non-psychotic disorders such as generalized anxiety disorder, major depressive disorder, obsessive-compulsive disorder, posttraumatic stress disorder.\n2. Family history (among first-degree relatives) of schizophrenia, bipolar disorder, or other psychotic disorder\n3. History of cardiovascular disorders.\n4. Pregnant or breastfeeding women or women of childbearing age not using effective contraception.\n5. Use of psilocybin or other psychedelic compound in the 12 months preceding the study\n6. Use of medications that interact with psilocybin or D-Serine.\n7. Positive urinary drug screening.",true,"ALL","25 Years","60 Years",{"count":234,"type":235},10,"ESTIMATED","INTERVENTIONAL",[238],"PHASE1","The goal of this open-label, dose-escalation, prospective study is to evaluate the safety and psychological effects of a Psilocybin and D-Serine formulation in healthy volunteers.\n\nThe main objectives are:\n\n1. To assess the psychological and physiological effects of psilocybin administered with D-Serine in healthy adults.\n2. To determine whether D-Serine modulates or attenuates the psychedelic effects of psilocybin.\n3. To evaluate the safety and tolerability of psilocybin and D-Serine co-administration.\n\nStudy population includes: 10 healthy male or female volunteers aged 25-60 years with no history of psychiatric or major medical disorders and no current evidence of such disorders.\n\nThe study includes two cohorts. The first cohort of 5 participants will receive 15 mg of Psilocybin and 5 g of D-Serine. Safety data will be collected and submitted in an interim report to the Ethics Committee. If no safety concerns arise, the second cohort will receive an increased dose of 25 mg of Psilocybin and 7 g of D-Serine to help determine the optimal dose for a future Phase IIa clinical trial.",[241],"Healthy Volunteers",[243],"psilocybin D-Serine healthy volunteers","2026-02-03",{"date":246,"type":247},"2026-02-05","ACTUAL",{"date":249,"type":247},"2025-12-11",{"date":251,"type":235},"2027-02",{"name":5,"class":6},1]