{"protocolSection":{"identificationModule":{"nctId":"NCT03429075","orgStudyIdInfo":{"id":"17HH3790"},"secondaryIdInfos":[{"id":"2017-000219-18","type":"EUDRACT_NUMBER"},{"id":"2017","type":"NIH","link":"https://reporter.nih.gov/quickSearch/2017"}],"organization":{"fullName":"Imperial College London","class":"OTHER"},"briefTitle":"Psilocybin vs Escitalopram for Major Depressive Disorder: Comparative Mechanisms","officialTitle":"Psilocybin vs Escitalopram for Major Depressive Disorder: Comparative Mechanisms","acronym":"Psilodep-RCT"},"statusModule":{"statusVerifiedDate":"2024-08","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2019-01-07","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2020-04-17","type":"ACTUAL"},"completionDateStruct":{"date":"2020-10-17","type":"ACTUAL"},"studyFirstSubmitDate":"2017-12-06","studyFirstSubmitQcDate":"2018-02-05","studyFirstPostDateStruct":{"date":"2018-02-12","type":"ACTUAL"},"resultsFirstSubmitDate":"2021-08-05","resultsFirstSubmitQcDate":"2024-08-02","resultsFirstPostDateStruct":{"date":"2024-10-24","type":"ACTUAL"},"lastUpdateSubmitDate":"2024-08-02","lastUpdatePostDateStruct":{"date":"2024-10-24","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Imperial College London","class":"OTHER"},"collaborators":[{"name":"Alexander Mosely Charitable Trust","class":"OTHER"}]},"oversightModule":{"oversightHasDmc":false,"isFdaRegulatedDrug":false,"isFdaRegulatedDevice":false},"descriptionModule":{"briefSummary":"This is a randomised double-blind clinical trial. The aim is to compare the efficacy and mechanisms of action of psilocybin, the primary psychoactive substance in 'magic mushrooms', with the selective serotonin reuptake inhibitor (SSRI) escitalopram for major depressive disorder (MDD)."},"conditionsModule":{"conditions":["Depressive Disorder, Major"],"keywords":["depression","mdd","major depression","major depressive disorder","unipolar depression","psilocybin","psychedelics","psychedelic","escitalopram","ssri"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE2"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"DOUBLE","whoMasked":["PARTICIPANT","INVESTIGATOR"]}},"enrollmentInfo":{"count":59,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Psilocybin","type":"EXPERIMENTAL","description":"Patients receive Psilocybin","interventionNames":["Drug: Psilocybin + Placebo"]},{"label":"Escitalopram","type":"ACTIVE_COMPARATOR","description":"Patients receive Escitalopram","interventionNames":["Drug: Psilocybin + Escitalopram"]}],"interventions":[{"type":"DRUG","name":"Psilocybin + Placebo","description":"Multiple dosing days psilocybin vs 6 weeks of daily placebo","armGroupLabels":["Psilocybin"]},{"type":"DRUG","name":"Psilocybin + Escitalopram","description":"Multiple dosing days psilocybin vs 6 weeks of daily escitalopram","armGroupLabels":["Escitalopram"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Percentage Change of the BOLD Signal","description":"Patients were tested with functional magnetic resonance imaging (fMRI) to measure brain brain responses to emotional faces before and after the treatment. The 2 values of BOLD signal (before and after exposure to emotional faces) were used to estimate a percentage value per patient and then these were used to estimated a group percentage change.","timeFrame":"Baseline measure vs 6 weeks post 1st psilocybin dosing"},{"measure":"Change in QIDS-16: Quick Inventory of Depressive Symptomatology Self-Rated (QIDS-16)","description":"Change in QIDS-16 (self-rated measure of depressive symptoms). Scale is composed of 16 items that correlate with the 9 Diagnostic Statistical Manual (DSM-IV) symptom criteria for depression. Each response is graded 0-4 (none-severe symptoms). Questions 1-4 concern sleep disturbances, Question 5 addresses sad mood, Questions 6-9 appetite/weight, Question 10 concentration, Question 11 self-criticism, Question 12 suicidal ideation, Question 13 interest, Q14 energy/fatigue and Questions 15-16 psychomotor agitation/retardation. All questions that address the same topic are grouped and only the highest score from each group is summed up together with the other questions in order to produce a total score. Scores can range from 0-27 and depression severity is graded based on the total score in the following way: 1-5 = No depression 6-10 = Mild depression 11-15 = Moderate depression 16-20 = Severe depression 21-27 = Very severe depression\n\nLower score =better outcome (less depression)","timeFrame":"Baseline vs 6 weeks post 1st psilocybin dosing"}],"secondaryOutcomes":[{"measure":"Change in Hamilton Depression Scale (HAMD-17)","description":"HAMD-17: clinician rated Hamilton Depression Scale of depression severity. Range of scores: 0-52: where 0-7 is normal, 8-16 is mild, 17-23 is moderate, \\>23 is severe.\n\nA threshold score of 17 is the entry: a score of 17 or higher indicated moderate-severe depression and was a requirement for entry into this trial at the screening point. This baseline does not refer to the screening point, it refers to the HAMD conducted 7-10 days before psilocybin dosing.\n\nA higher decrease in the HAMD (larger negative change score) is a better outcome.","timeFrame":"Change from baseline (7-10 days pre-dosing) to 6 weeks after the first psilocybin dose"},{"measure":"Change in Beck Depression Inventory (BDI-IA)","description":"BDI-IA: patient-rated Beck Depression Inventory, depressive symptomatology scale. Higher score = worse depression. The total score range is 0-63: where 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe\n\nHigher negative score = greater decrease in depression scores 6 weeks after each treatment arm = better outcome.","timeFrame":"Change from baseline (7-10 days pre-dosing) to 6 weeks after the first psilocybin dose"},{"measure":"Change in MADRS","description":"MADRS - Montgomery-Asberg Depression Rating Scale, clinician-rated measure of depression. This scale is clinician-rated and consists of 10 items; each item is rated on a 0-6 scale, resulting in a maximum total score of 60 points, with higher scores indicative of greater depressive symptomology.36 The MADRS scoring instructions indicate that a total score ranging from 0 to 6 indicates that the patient is in the normal range (no depression), a score ranging from 7 to 19 indicates \"mild depression,\" 20 to 34 indicates \"moderate depression,\" a score of 35 and greater indicates \"severe depression,\" and a total score of 60 or greater indicates \"very severe depression.\"\n\nA higher decrease in the MADRS (larger negative change score) is a better outcome.","timeFrame":"Change from baseline (7-10 days pre-dosing) to 6 weeks after the first psilocybin dose"},{"measure":"Number of Patients Who \"Responded\": Quick Inventory of Depressive Symptomatology (QIDS-16) Response at 6 Weeks","description":"Number of patients who \"responded\" on the QIDS-16 scale (Quick Inventory of Depressive Symptomatology, self-rated). \"Response\" is defined by a decrease in QIDS score of 50% from baseline.\n\nHigher number of patients who responded = better outcome for treatment arm.","timeFrame":"Change from baseline (7-10 days pre-dosing) to 6 weeks after the first psilocybin dose"},{"measure":"Number of Patients Who \"Remitted\": QIDS-16 Remission Rate","description":"Number of patients who \"remitted\" on the QIDS-16 scale (Quick Inventory of Depressive Symptomatology, self-rated). \"Remission\" is defined by having a QIDS score below 5 at the 6 week point = no depression.\n\nHigher remission rate = better outcome (less depressed patients after treatment)","timeFrame":"Change from baseline (7-10 days pre-dosing) to 6 weeks after the first psilocybin dose"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n1. Major depressive disorder (DSM-IV)\n2. Depression of moderate to severe degree (17+ on the 17-item Hamilton Depression Scale (HAM-D)).\n3. No Magnetic Resonance Imaging (MRI) contraindications\n4. No SSRI contraindications\n5. Has a general practitioner (GP) or other mental healthcare professional who can confirm diagnosis\n6. 18-80 years of age\n7. Males and females\n8. Sufficiently competent with English language\n\nKey exclusion criteria:\n\n1. Current or previously diagnosed psychotic disorder\n2. Immediate family member with a diagnosed psychotic disorder\n3. Medically significant condition rendering unsuitability for the study (e.g., diabetes, epilepsy, severe cardiovascular disease, hepatic or renal failure e.g. creatine clearance:renal clearance (CLRC) \\< 30 ml/min etc.)\n4. History of serious suicide attempts requiring hospitalisation.\n5. Significant history of mania (determined by study psychiatrist and medical records)\n6. Psychiatric condition judged to be incompatible with establishment of rapport with therapy team and/or safe exposure to psilocybin, e.g. borderline personality disorder\n7. Blood or needle phobia\n8. Positive pregnancy test at screening or during the study, women who are planning a pregnancy and/or women who are nursing/breastfeeding.\n9. Participants who do not agree to use an acceptable contraceptive method throughout their participation in study.\n10. Current drug or alcohol dependence\n11. No email access\n12. Use of contraindicated medication\n13. Patients presenting with abnormal QT interval prolongation at screening or with a history of this (QTc at screening above 440ms for men and above 470ms for women)","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","maximumAge":"80 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"David J Nutt, Medicine","affiliation":"Imperial College London","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"Imperial College Hammersmith campus","city":"London","zip":"W12 0NN","country":"United Kingdom","geoPoint":{"lat":51.50853,"lon":-0.12574}}]},"referencesModule":{"references":[{"pmid":"29119217","type":"BACKGROUND","citation":"Carhart-Harris RL, Bolstridge M, Day CMJ, Rucker J, Watts R, Erritzoe DE, Kaelen M, Giribaldi B, Bloomfield M, Pilling S, Rickard JA, Forbes B, Feilding A, Taylor D, Curran HV, Nutt DJ. Psilocybin with psychological support for treatment-resistant depression: six-month follow-up. Psychopharmacology (Berl). 2018 Feb;235(2):399-408. doi: 10.1007/s00213-017-4771-x. Epub 2017 Nov 8."},{"pmid":"33852780","type":"RESULT","citation":"Carhart-Harris R, Giribaldi B, Watts R, Baker-Jones M, Murphy-Beiner A, Murphy R, Martell J, Blemings A, Erritzoe D, Nutt DJ. Trial of Psilocybin versus Escitalopram for Depression. N Engl J Med. 2021 Apr 15;384(15):1402-1411. doi: 10.1056/NEJMoa2032994."},{"pmid":"39764567","type":"DERIVED","citation":"Erritzoe D, Barba T, Greenway KT, Murphy R, Martell J, Giribaldi B, Timmermann C, Murphy-Beiner A, Jones MB, Nutt D, Weiss B, Carhart-Harris R. Effect of psilocybin versus escitalopram on depression symptom severity in patients with moderate-to-severe major depressive disorder: observational 6-month follow-up of a phase 2, double-blind, randomised, controlled trial. EClinicalMedicine. 2024 Sep 21;76:102799. doi: 10.1016/j.eclinm.2024.102799. eCollection 2024 Oct."},{"pmid":"38605658","type":"DERIVED","citation":"Peill J, Marguilho M, Erritzoe D, Barba T, Greenway KT, Rosas F, Timmermann C, Carhart-Harris R. Psychedelics and the 'inner healer': Myth or mechanism? J Psychopharmacol. 2024 May;38(5):417-424. doi: 10.1177/02698811241239206. Epub 2024 Apr 12."},{"pmid":"38247730","type":"DERIVED","citation":"Szigeti B, Weiss B, Rosas FE, Erritzoe D, Nutt D, Carhart-Harris R. Assessing expectancy and suggestibility in a trial of escitalopram v. psilocybin for depression. Psychol Med. 2024 Jun;54(8):1717-1724. doi: 10.1017/S0033291723003653. Epub 2024 Jan 22."},{"pmid":"37337526","type":"DERIVED","citation":"Nayak SM, Bari BA, Yaden DB, Spriggs MJ, Rosas FE, Peill JM, Giribaldi B, Erritzoe D, Nutt DJ, Carhart-Harris R. A Bayesian Reanalysis of a Trial of Psilocybin versus Escitalopram for Depression. Psychedelic Med (New Rochelle). 2023 Mar;1(1):18-26. doi: 10.1089/psymed.2022.0002. Epub 2022 Oct 28."},{"pmid":"35431912","type":"DERIVED","citation":"Murphy R, Kettner H, Zeifman R, Giribaldi B, Kartner L, Martell J, Read T, Murphy-Beiner A, Baker-Jones M, Nutt D, Erritzoe D, Watts R, Carhart-Harris R. Therapeutic Alliance and Rapport Modulate Responses to Psilocybin Assisted Therapy for Depression. Front Pharmacol. 2022 Mar 31;12:788155. doi: 10.3389/fphar.2021.788155. eCollection 2021."},{"pmid":"35411074","type":"DERIVED","citation":"Daws RE, Timmermann C, Giribaldi B, Sexton JD, Wall MB, Erritzoe D, Roseman L, Nutt D, Carhart-Harris R. Increased global integration in the brain after psilocybin therapy for depression. Nat Med. 2022 Apr;28(4):844-851. doi: 10.1038/s41591-022-01744-z. Epub 2022 Apr 11."}]},"ipdSharingStatementModule":{"ipdSharing":"NO"}},"resultsSection":{"participantFlowModule":{"groups":[{"id":"FG000","title":"Psilocybin","description":"Patients receive two doses of 25mg psilocybin, 3 weeks apart. After the first dose of 25mg psilocybin, patients start taking one daily placebo tablet every morning for 3 weeks. After their second 25mg psilocybin session, patients start taking two daily placebo tablets for another 3 weeks.\n\nAll tablets are identical and visit procedures are identical otherwise."},{"id":"FG001","title":"Escitalopram","description":"Patients receive two doses of 1mg psilocybin (considered to be virtually placebo), 3 weeks apart. After the first dose of 1mg psilocybin, patients start taking one daily 10mg escitalopram tablet every morning for 3 weeks. After their second 1mg psilocybin session, patients start taking two daily tablets of escitalopram (10mg each, 20mg in total) for another 3 weeks.\n\nAll tablets are identical and visit procedures are identical otherwise."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"30"},{"groupId":"FG001","numSubjects":"29"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"30"},{"groupId":"FG001","numSubjects":"29"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Psilocybin","description":"Patients receive two doses of 25mg psilocybin, 3 weeks apart. After the first dose of 25mg psilocybin, patients start taking one daily placebo tablet every morning for 3 weeks. After their second 25mg psilocybin session, patients start taking two daily placebo tablets for another 3 weeks.\n\nAll tablets are identical and visit procedures are identical otherwise."},{"id":"BG001","title":"Escitalopram","description":"Patients receive two doses of 1mg psilocybin (considered to be virtually placebo), 3 weeks apart. After the first dose of 1mg psilocybin, patients start taking one daily 10mg escitalopram tablet every morning for 3 weeks. After their second 1mg psilocybin session, patients start taking two daily tablets of escitalopram (10mg each, 20mg in total) for another 3 weeks.\n\nAll tablets are identical and visit procedures are identical otherwise."},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"30"},{"groupId":"BG001","value":"29"},{"groupId":"BG002","value":"59"}]}],"measures":[{"title":"Age, Categorical","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"<=18 years","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Between 18 and 65 years","measurements":[{"groupId":"BG000","value":"30"},{"groupId":"BG001","value":"29"},{"groupId":"BG002","value":"59"}]},{"title":">=65 years","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]}]}]},{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"43.3","spread":"11.7"},{"groupId":"BG001","value":"39.1","spread":"9.7"},{"groupId":"BG002","value":"41.2","spread":"10.9"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"11"},{"groupId":"BG001","value":"9"},{"groupId":"BG002","value":"20"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"19"},{"groupId":"BG001","value":"20"},{"groupId":"BG002","value":"39"}]}]}]},{"title":"Race/Ethnicity, Customized","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"White","categories":[{"measurements":[{"groupId":"BG000","value":"28"},{"groupId":"BG001","value":"24"},{"groupId":"BG002","value":"52"}]}]},{"title":"Asian","categories":[{"measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"4"},{"groupId":"BG002","value":"5"}]}]},{"title":"Mixed Asian + White","categories":[{"measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"2"}]}]}]},{"title":"Region of Enrollment","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"United Kingdom","categories":[{"measurements":[{"groupId":"BG000","value":"30"},{"groupId":"BG001","value":"29"},{"groupId":"BG002","value":"59"}]}]}]},{"title":"No previous psilocybin use","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"22"},{"groupId":"BG001","value":"21"},{"groupId":"BG002","value":"43"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Percentage Change of the BOLD Signal","description":"Patients were tested with functional magnetic resonance imaging (fMRI) to measure brain brain responses to emotional faces before and after the treatment. The 2 values of BOLD signal (before and after exposure to emotional faces) were used to estimate a percentage value per patient and then these were used to estimated a group percentage change.","populationDescription":"The data obtained from an imaging group in the trial, in which functional MRI was used to predict responses to the trial drugs, have not been analyzed.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"percentage change in BOLD signal","timeFrame":"Baseline measure vs 6 weeks post 1st psilocybin dosing","groups":[{"id":"OG000","title":"Psilocybin","description":"Patients receive Psilocybin\n\nPsilocybin + Placebo: Multiple dosing days psilocybin vs 6 weeks of daily placebo"},{"id":"OG001","title":"Escitalopram","description":"Patients receive Escitalopram\n\nPsilocybin + Escitalopram: Multiple dosing days psilocybin vs 6 weeks of daily escitalopram"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"25"},{"groupId":"OG001","value":"21"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.08","spread":"0.45"},{"groupId":"OG001","value":"0.43","spread":"0.62"}]}]}]},{"type":"PRIMARY","title":"Change in QIDS-16: Quick Inventory of Depressive Symptomatology Self-Rated (QIDS-16)","description":"Change in QIDS-16 (self-rated measure of depressive symptoms). Scale is composed of 16 items that correlate with the 9 Diagnostic Statistical Manual (DSM-IV) symptom criteria for depression. Each response is graded 0-4 (none-severe symptoms). Questions 1-4 concern sleep disturbances, Question 5 addresses sad mood, Questions 6-9 appetite/weight, Question 10 concentration, Question 11 self-criticism, Question 12 suicidal ideation, Question 13 interest, Q14 energy/fatigue and Questions 15-16 psychomotor agitation/retardation. All questions that address the same topic are grouped and only the highest score from each group is summed up together with the other questions in order to produce a total score. Scores can range from 0-27 and depression severity is graded based on the total score in the following way: 1-5 = No depression 6-10 = Mild depression 11-15 = Moderate depression 16-20 = Severe depression 21-27 = Very severe depression\n\nLower score =better outcome (less depression)","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"score on a scale","timeFrame":"Baseline vs 6 weeks post 1st psilocybin dosing","groups":[{"id":"OG000","title":"Psilocybin","description":"Patients receive two doses of 25mg psilocybin, 3 weeks apart. After the first dose of 25mg psilocybin, patients start taking one daily placebo tablet every morning for 3 weeks. After their second 25mg psilocybin session, patients start taking two daily placebo tablets for another 3 weeks.\n\nAll tablets are identical and visit procedures are identical otherwise."},{"id":"OG001","title":"Escitalopram","description":"Patients receive two doses of 1mg psilocybin (considered to be virtually placebo), 3 weeks apart. After the first dose of 1mg psilocybin, patients start taking one daily 10mg escitalopram tablet every morning for 3 weeks. After their second 1mg psilocybin session, patients start taking two daily tablets of escitalopram (10mg each, 20mg in total) for another 3 weeks.\n\nAll tablets are identical and visit procedures are identical otherwise."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"30"},{"groupId":"OG001","value":"29"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-8","spread":"1"},{"groupId":"OG001","value":"-6","spread":"1"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"EQUIVALENCE","nonInferiorityComment":"ANCOVA","pValue":"0.17","statisticalMethod":"ANCOVA"}]},{"type":"SECONDARY","title":"Change in Hamilton Depression Scale (HAMD-17)","description":"HAMD-17: clinician rated Hamilton Depression Scale of depression severity. Range of scores: 0-52: where 0-7 is normal, 8-16 is mild, 17-23 is moderate, \\>23 is severe.\n\nA threshold score of 17 is the entry: a score of 17 or higher indicated moderate-severe depression and was a requirement for entry into this trial at the screening point. This baseline does not refer to the screening point, it refers to the HAMD conducted 7-10 days before psilocybin dosing.\n\nA higher decrease in the HAMD (larger negative change score) is a better outcome.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"units on a scale","timeFrame":"Change from baseline (7-10 days pre-dosing) to 6 weeks after the first psilocybin dose","groups":[{"id":"OG000","title":"Psilocybin","description":"Patients receive two doses of 25mg psilocybin, 3 weeks apart. After the first dose of 25mg psilocybin, patients start taking one daily placebo tablet every morning for 3 weeks. After their second 25mg psilocybin session, patients start taking two daily placebo tablets for another 3 weeks.\n\nAll tablets are identical and visit procedures are identical otherwise."},{"id":"OG001","title":"Escitalopram","description":"Patients receive two doses of 1mg psilocybin (considered to be virtually placebo), 3 weeks apart. After the first dose of 1mg psilocybin, patients start taking one daily 10mg escitalopram tablet every morning for 3 weeks. After their second 1mg psilocybin session, patients start taking two daily tablets of escitalopram (10mg each, 20mg in total) for another 3 weeks.\n\nAll tablets are identical and visit procedures are identical otherwise."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"30"},{"groupId":"OG001","value":"29"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-10.5","spread":"1"},{"groupId":"OG001","value":"-5.1","spread":"1"}]}]}]},{"type":"SECONDARY","title":"Change in Beck Depression Inventory (BDI-IA)","description":"BDI-IA: patient-rated Beck Depression Inventory, depressive symptomatology scale. Higher score = worse depression. The total score range is 0-63: where 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe\n\nHigher negative score = greater decrease in depression scores 6 weeks after each treatment arm = better outcome.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"95% Confidence Interval","unitOfMeasure":"units on a scale","timeFrame":"Change from baseline (7-10 days pre-dosing) to 6 weeks after the first psilocybin dose","groups":[{"id":"OG000","title":"Psilocybin","description":"Patients receive two doses of 25mg psilocybin, 3 weeks apart. After the first dose of 25mg psilocybin, patients start taking one daily placebo tablet every morning for 3 weeks. After their second 25mg psilocybin session, patients start taking two daily placebo tablets for another 3 weeks.\n\nAll tablets are identical and visit procedures are identical otherwise."},{"id":"OG001","title":"Escitalopram","description":"Patients receive two doses of 1mg psilocybin (considered to be virtually placebo), 3 weeks apart. After the first dose of 1mg psilocybin, patients start taking one daily 10mg escitalopram tablet every morning for 3 weeks. After their second 1mg psilocybin session, patients start taking two daily tablets of escitalopram (10mg each, 20mg in total) for another 3 weeks.\n\nAll tablets are identical and visit procedures are identical otherwise."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"30"},{"groupId":"OG001","value":"29"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-18.4","lowerLimit":"-22.6","upperLimit":"-13.8"},{"groupId":"OG001","value":"-10.8","lowerLimit":"-14.3","upperLimit":"-7.3"}]}]}]},{"type":"SECONDARY","title":"Change in MADRS","description":"MADRS - Montgomery-Asberg Depression Rating Scale, clinician-rated measure of depression. This scale is clinician-rated and consists of 10 items; each item is rated on a 0-6 scale, resulting in a maximum total score of 60 points, with higher scores indicative of greater depressive symptomology.36 The MADRS scoring instructions indicate that a total score ranging from 0 to 6 indicates that the patient is in the normal range (no depression), a score ranging from 7 to 19 indicates \"mild depression,\" 20 to 34 indicates \"moderate depression,\" a score of 35 and greater indicates \"severe depression,\" and a total score of 60 or greater indicates \"very severe depression.\"\n\nA higher decrease in the MADRS (larger negative change score) is a better outcome.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"score on a scale","timeFrame":"Change from baseline (7-10 days pre-dosing) to 6 weeks after the first psilocybin dose","groups":[{"id":"OG000","title":"Psilocybin","description":"Patients receive two doses of 25mg psilocybin, 3 weeks apart. After the first dose of 25mg psilocybin, patients start taking one daily placebo tablet every morning for 3 weeks. After their second 25mg psilocybin session, patients start taking two daily placebo tablets for another 3 weeks.\n\nAll tablets are identical and visit procedures are identical otherwise."},{"id":"OG001","title":"Escitalopram","description":"Patients receive two doses of 1mg psilocybin (considered to be virtually placebo), 3 weeks apart. After the first dose of 1mg psilocybin, patients start taking one daily 10mg escitalopram tablet every morning for 3 weeks. After their second 1mg psilocybin session, patients start taking two daily tablets of escitalopram (10mg each, 20mg in total) for another 3 weeks.\n\nAll tablets are identical and visit procedures are identical otherwise."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"30"},{"groupId":"OG001","value":"29"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"14.4","spread":"1.7"},{"groupId":"OG001","value":"-7.2","spread":"1.7"}]}]}]},{"type":"SECONDARY","title":"Number of Patients Who \"Responded\": Quick Inventory of Depressive Symptomatology (QIDS-16) Response at 6 Weeks","description":"Number of patients who \"responded\" on the QIDS-16 scale (Quick Inventory of Depressive Symptomatology, self-rated). \"Response\" is defined by a decrease in QIDS score of 50% from baseline.\n\nHigher number of patients who responded = better outcome for treatment arm.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"participants","timeFrame":"Change from baseline (7-10 days pre-dosing) to 6 weeks after the first psilocybin dose","groups":[{"id":"OG000","title":"Psilocybin","description":"Patients receive two doses of 25mg psilocybin, 3 weeks apart. After the first dose of 25mg psilocybin, patients start taking one daily placebo tablet every morning for 3 weeks. After their second 25mg psilocybin session, patients start taking two daily placebo tablets for another 3 weeks.\n\nAll tablets are identical and visit procedures are identical otherwise."},{"id":"OG001","title":"Escitalopram","description":"Patients receive two doses of 1mg psilocybin (considered to be virtually placebo), 3 weeks apart. After the first dose of 1mg psilocybin, patients start taking one daily 10mg escitalopram tablet every morning for 3 weeks. After their second 1mg psilocybin session, patients start taking two daily tablets of escitalopram (10mg each, 20mg in total) for another 3 weeks.\n\nAll tablets are identical and visit procedures are identical otherwise."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"30"},{"groupId":"OG001","value":"29"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"21"},{"groupId":"OG001","value":"14"}]}]}]},{"type":"SECONDARY","title":"Number of Patients Who \"Remitted\": QIDS-16 Remission Rate","description":"Number of patients who \"remitted\" on the QIDS-16 scale (Quick Inventory of Depressive Symptomatology, self-rated). \"Remission\" is defined by having a QIDS score below 5 at the 6 week point = no depression.\n\nHigher remission rate = better outcome (less depressed patients after treatment)","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"participants","timeFrame":"Change from baseline (7-10 days pre-dosing) to 6 weeks after the first psilocybin dose","groups":[{"id":"OG000","title":"Psilocybin","description":"Patients receive two doses of 25mg psilocybin, 3 weeks apart. 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After their second 25mg psilocybin session, patients start taking two daily placebo tablets for another 3 weeks.\n\nAll tablets are identical and visit procedures are identical otherwise.","deathsNumAffected":0,"deathsNumAtRisk":30,"seriousNumAffected":0,"seriousNumAtRisk":30,"otherNumAffected":26,"otherNumAtRisk":30},{"id":"EG001","title":"Escitalopram","description":"Patients receive two doses of 1mg psilocybin (considered to be virtually placebo), 3 weeks apart. After the first dose of 1mg psilocybin, patients start taking one daily 10mg escitalopram tablet every morning for 3 weeks. 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