[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100530269":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":29,"centralContacts":30,"locations":36,"responsibleParty":51,"collaborators":29,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":61,"eligibilityCriteria":62,"healthyVolunteers":57,"sex":63,"minAge":64,"maxAge":65,"enrollmentInfo":66,"targetDuration":29,"studyType":69,"phases":70,"briefSummary":72,"conditions":73,"keywords":29,"overallStatus":39,"whyStopped":29,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},{"fullName":5,"class":6},"University Hospital Bispebjerg and Frederiksberg","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Lithium","EXPERIMENTAL","tablet",[13],"Drug: Lithium Carbonate",{"label":15,"type":16,"description":11,"interventionNames":17},"Lamotrigine","ACTIVE_COMPARATOR",[18],"Drug: Lamotrigine",[20,27],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Lithium Carbonate","The trial is designed as a single-blinded two-armed, parallel randomized trial with randomization 1:1 to lamotrigine versus lithium.",[9],[26],"lithium citrate",{"type":21,"name":15,"description":23,"armGroupLabels":28,"otherNames":29},[15],null,[31],{"name":32,"role":33,"phone":34,"phoneExt":29,"email":35},"Lars Vedel Kessing, professor, MD, DMSc.","CONTACT","+45 38 64 70 81","lars.vedel.kessing@regionh.dk",[37],{"facility":38,"status":39,"city":40,"state":29,"zip":29,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Psychiatric Center Copenhagen","RECRUITING","Copenhagen","Denmark","DK",{"type":44,"coordinates":45},"Point",[46,47],12.56553,55.67594,{"lat":47,"lon":46},[50],{"name":32,"role":33,"phone":34,"phoneExt":29,"email":35},{"type":52,"investigatorFullName":53,"investigatorTitle":54,"investigatorAffiliation":5,"oldNameTitle":29,"oldOrganization":29},"PRINCIPAL_INVESTIGATOR","Lars Vedel Kessing","professor, MD, DMSc.","100530269","phase-4-lithium-versus-lamotrigine-in-bipolar-disorder-type-ii-100530269",false,"NCT06184581","Lithium Versus Lamotrigine in Bipolar Disorder, Type II","Lithium Versus Lamotrigine in Bipolar Disorder, Type II - a Single Blinded Randomized Controlled Trial (the LiLa-Bipolar RCT)","LiLa-Bipolar","Inclusion Criteria:\n\n* Bipolar disorder, type II with diagnosis confirmed by SCAN interview\n* Age 18-70 years\n* Habile (i.e., able to give informed consent)\n\nExclusion Criteria:\n\n* Past non-response or intolerance to lamotrigine or lithium with \\> 6 weeks treatment at an adequate dosage\n* Currently taking mood stabilizers at enrollment in CADIC\n* Severe chronic kidney disease\n* Severe cardiac insufficiency\n* Brugadas syndrome\n* Severe hypothyroidism despite treatment\n* Women who are pregnant, breastfeeding or planning pregnancy in near future.","ALL","18 Years","70 Years",{"count":67,"type":68},200,"ESTIMATED","INTERVENTIONAL",[71],"PHASE4","The investigators want in a 6-month randomized controlled trial (RCT) to compare effects of lithium versus lamotrigine on mood stabilization and other critical patient outcomes in patients with BDII.",[74],"Bipolar II Disorder","2026-03-17",{"date":77,"type":78},"2026-03-20","ACTUAL",{"date":80,"type":78},"2024-05-08",{"date":82,"type":68},"2027-12-01",{"name":5,"class":6},1]