[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100646148":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":37,"responsibleParty":54,"collaborators":58,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":71,"eligibilityCriteria":72,"healthyVolunteers":67,"sex":73,"minAge":74,"maxAge":75,"enrollmentInfo":76,"targetDuration":26,"studyType":79,"phases":80,"briefSummary":83,"conditions":84,"keywords":87,"overallStatus":40,"whyStopped":26,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"fullName":5,"class":6},"Universidade do Sul de Santa Catarina","OTHER_GOV",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"CBD Full Spectrum 100 mg\u002FmL","EXPERIMENTAL","Participants assigned to this arm will receive full-spectrum cannabidiol (CBD) oil containing 100 mg\u002FmL of CBD administered sublingually for 12 weeks under double-blind conditions. The formulation contains cannabidiol and naturally occurring phytocannabinoids and terpenes derived from Cannabis sativa. Clinical assessments will be conducted at baseline, Week 4, and Week 12 to evaluate efficacy, safety, tolerability, and treatment adherence.",[13],"Drug: Full-spectrum CBD oil 100 mg\u002FmL",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo (MCT oil)","PLACEBO_COMPARATOR","Participants assigned to this arm will receive a placebo formulation consisting of medium-chain triglyceride (MCT) oil administered sublingually for 12 weeks under double-blind conditions. The placebo will be identical in appearance, color, viscosity, taste, and packaging to the active full-spectrum CBD oil to ensure maintenance of treatment blinding. Clinical assessments will be conducted at baseline, Week 4, and Week 12 to evaluate study outcomes, safety, tolerability, and adherence.",[19],"Drug: Placebo oil (MCT oil)",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Full-spectrum CBD oil 100 mg\u002FmL","Full-spectrum Cannabis sativa extract containing cannabidiol (CBD) 100 mg\u002FmL and tetrahydrocannabinol (THC) 3.33 mg\u002FmL, administered sublingually for 12 weeks according to a structured dose titration schedule. Treatment will begin with low doses and may be gradually adjusted based on clinical response and tolerability, respecting predefined safety limits established in the study protocol.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Placebo oil (MCT oil)","Placebo comparator consisting of medium-chain triglyceride (MCT) oil administered sublingually for 12 weeks according to the same dose titration schedule used in the experimental group. The placebo formulation is matched to the active intervention in appearance, color, viscosity, packaging, and administration conditions to maintain blinding throughout the study. Treatment adherence, tolerability, and adverse events will be monitored throughout the intervention period.",[15],[32],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Rafael Mariano Bitencourt, PhD","CONTACT","+55 48 9 8833-6460","bitencourtrm@gmail.com",[38],{"facility":39,"status":40,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Universidade do Sul de Santa Catarina - UNISUL","RECRUITING","Tubarão","Santa Catarina","88704900","Brazil","BR",{"type":47,"coordinates":48},"Point",[49,50],-49.00694,-28.46667,{"lat":50,"lon":49},[53],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},{"type":55,"investigatorFullName":56,"investigatorTitle":57,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Rafael Mariano de Bitencourt","Principal Investigator",[59,62],{"name":60,"class":61},"Federal University of Latin American Integration","OTHER",{"name":63,"class":64},"Associação Cannabis Sem Fronteiras - ACSF","UNKNOWN","100646148","phase-1-cannabidiol-oil-for-treatment-resistant-major-depression-100646148",false,"NCT07696871","Cannabidiol Oil for Treatment-Resistant Major Depression","Effects of Full-Spectrum Cannabidiol Oil on Symptoms of Treatment-Resistant Major Depressive Disorder: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Clinical Trial","ANANDA","Inclusion Criteria:\n\n* Adults aged 18 to 69 years\n* Diagnosis of Major Depressive Disorder (MDD)\n* Persistent depressive symptoms despite ongoing antidepressant treatment\n* Stable antidepressant treatment for at least four weeks before enrollment\n* Residence in Brazil\n* Ability to understand study procedures and comply with study requirements\n* Provision of written informed consent\n\nExclusion Criteria:\n\n* Current use of cannabis-derived products or cannabinoid-based medications\n* Diagnosis of bipolar disorder, schizophrenia, or other psychotic disorders\n* Current substance use disorder, except nicotine or caffeine\n* Pregnancy or breastfeeding\n* Severe or unstable medical conditions that may interfere with study participation\n* History of hypersensitivity or allergy to Cannabis sativa products or MCT oil\n* Active suicidal ideation or significant suicide risk requiring immediate intervention\n* Participation in another clinical trial within the previous 30 days\n* Inability to comply with study procedures or follow-up assessments","ALL","18 Years","69 Years",{"count":77,"type":78},120,"ESTIMATED","INTERVENTIONAL",[81,82],"PHASE1","PHASE2","Major depressive disorder is one of the leading causes of disability worldwide, and a substantial proportion of patients do not achieve adequate improvement with conventional antidepressant treatments. Cannabidiol (CBD), a non-intoxicating cannabinoid derived from Cannabis sativa, has shown potential anxiolytic, anti-inflammatory, and neurobiological effects that may be relevant for depressive disorders.\n\nThe ANANDA trial is a multicenter, randomized, double-blind, placebo-controlled clinical trial designed to evaluate the efficacy, safety, and tolerability of full-spectrum cannabidiol oil as an adjunctive treatment in adults with treatment-resistant major depressive disorder.\n\nA total of 120 participants will be randomly assigned to receive either full-spectrum cannabidiol oil or placebo for 12 weeks while maintaining stable antidepressant treatment. Clinical assessments of depressive symptoms, anxiety, sleep quality, perceived stress, and adverse effects will be performed at baseline, Week 4, and Week 12. Blood samples will be collected at baseline and after 12 weeks to investigate inflammatory and neuroendocrine biomarkers.\n\nThe primary objective is to evaluate changes in depressive symptoms after 12 weeks of treatment. Secondary objectives include the assessment of anxiety, sleep quality, perceived stress, biological markers, safety, and tolerability.\n\nThe findings of this study may contribute to the development of new therapeutic approaches for treatment-resistant depression and provide additional evidence regarding the clinical use of cannabidiol in psychiatric disorders.",[85,86],"Major Depressive Disorder (MDD)","Treatment-resistant Depression (TRD)",[88,89,90,91,92],"Cannabidiol","Cannabinoids","Major Depressive Disorder","Treatment-Resistant Depression","Mood Disorders","2026-07-08",{"date":95,"type":96},"2026-07-10","ACTUAL",{"date":98,"type":96},"2026-06-01",{"date":100,"type":78},"2026-12-31",{"name":5,"class":6},1]