protocolSection identificationModule nctId: NCT06319378, orgStudyIdInfo id: CAPSI no 2 date 231024, secondaryIdInfos id: 2023-505532-35-00, type: OTHER, domain: CTIS, briefTitle: Cancer Related Major Depression Treated With a Single Dose of Psilocybin, acronym: CAPSI, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-17, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: Section for Affective Disorders; Northern Stockholm Psychiatry, class: OTHER, collaborators name: Uppsala University Hospital, collaborators name: Region Örebro County, collaborators name: Vastra Gotaland Region, collaborators name: Karolinska Institutet, descriptionModule briefSummary: The goal of this randomized placebo controlled trial is to compare the antidepressant effect of a single oral dose of psilocybin 25 mg compared to 1 mg in 100 patients with cancer related major depressive disorder. The main question it aims to answer is:The primary objective of this study is to evaluate the efficacy of a single 25 mg oral dose of psilocybin for major depressive disorder (MDD) compared to an active placebo (psilocybin 1 mg) assessed as the difference between groups in changes in depressive symptoms, in the following Population: 20-80 (inclusive) years old, current depressive episode (according to Patient Health Questionnaire (PHQ-9)≥10), \>1 month after cancer diagnosis, with at least 12 months of life expectancy, willingness to abstain from other psychotherapeutic or antidepressant treatments during the study (wash out time 5 half-lives)., conditionsModule conditions: MDD, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomized Controlled Trial, active placebo, randomization ratio 2:1, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: psilocybin 25 mg sod, interventions name: psilocybin 1 mg sod, outcomesModule primaryOutcomes measure: MADRS at day 42, secondaryOutcomes measure: MADRS day 8, secondaryOutcomes measure: MADRS-S at all evaluations between Day 0 and Day 42 (Mixed Models for Repeated Measures (MMRM) x1), secondaryOutcomes measure: SDS at Day 42, secondaryOutcomes measure: CGI at Day 8 and Day 42 (analysis of covariance (ANCOVA) x6), secondaryOutcomes measure: EQ-5D-5L at Day 8 and Day 42 (ANCOVA x6), secondaryOutcomes measure: AQOL-6D at Day 42 (ANCOVA x1), secondaryOutcomes measure: MADRS at Day 90 and Day 180 (ANCOVA x2), secondaryOutcomes measure: MADRS-S at all evaluations between Day 43 and Day 180 (MMRM x1), secondaryOutcomes measure: SDS at Day 180 (ANCOVA x3), secondaryOutcomes measure: GAD-7 at Day 180 (ANCOVA x3), secondaryOutcomes measure: HADS at Day 180 (ANCOVA x3), secondaryOutcomes measure: CGI at Day 90 and Day 180 (ANCOVA x6), secondaryOutcomes measure: EQ-5D-5L at Day 90 and Day 180 (ANCOVA x6), secondaryOutcomes measure: AQOL-6D at Day 90 and Day 180 (ANCOVA x2), secondaryOutcomes measure: GAD-7 at Day 42, secondaryOutcomes measure: HADS at Day 42, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: region Västra Götaland, status: RECRUITING, city: Göteborg, country: Sweden, contacts name: Helena Werin Sjögren, MD, role: CONTACT, email: helena.werin.sjogren@vgregion.se, contacts name: Mikael Landén, MD PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 57.70716, lon: 11.96679, locations facility: Norra Stockholms Psykiatri, status: RECRUITING, city: Stockholm, country: Sweden, contacts name: Evana Lopez, MD, role: CONTACT, email: evana.lopez@ki.se, contacts name: Carl-Johan Ekman, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 59.33258, lon: 18.0649, locations facility: Psykiatriska Kliniken, Akademiska Sjukhuset, status: RECRUITING, city: Uppsala, country: Sweden, contacts name: Evana Lopez, role: CONTACT, email: evana.lopez@ki.se, contacts name: robert Bodén, MD PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 59.85882, lon: 17.63889, locations facility: Örebro sjukhus, status: RECRUITING, city: Örebro, country: Sweden, contacts name: Axel Nordenskjöld, MD PhD, role: CONTACT, contacts name: Evana Lopez, MD, role: CONTACT, email: evana.lopez@ki.se, contacts name: axel Nordenskjöld, MD PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 59.27412, lon: 15.2066, hasResults: False