[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100509478":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":31,"centralContacts":36,"locations":47,"responsibleParty":67,"collaborators":70,"id":80,"slug":81,"hasResults":82,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":86,"eligibilityCriteria":87,"healthyVolunteers":82,"sex":88,"minAge":89,"maxAge":90,"enrollmentInfo":91,"targetDuration":41,"studyType":94,"phases":95,"briefSummary":97,"conditions":98,"keywords":41,"overallStatus":49,"whyStopped":41,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":109},{"fullName":5,"class":6},"Aalborg University Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Lithium","EXPERIMENTAL","Lithium citrate from 12 mmol increased to result in af 12-hour se-lithium between 0.6 and 0.8 mmol\u002Fl",[13],"Drug: Lithium",{"label":15,"type":10,"description":16,"interventionNames":17},"Cariprazine","Cariprazine from 1.5 mg to 3 mg daily in a single dose.",[18],"Drug: Cariprazine",[20,26],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG","The starting dose (day one) of lithium citrate is 12 mmol (one tablet of lithium citrate contains 6 mmol lithium) given once a day before bedtime. On day three the dose is increased to 18 mmol. Dose adjustments are permitted after 7 days in a flexible manner to result in a 12-hour se-lithium between 0.6 and 0.8 mmol\u002Fl, aiming for the upper limit at the treating physician's discretion.",[9],[25],"Litarex, ATC; N05AN01",{"type":21,"name":15,"description":27,"armGroupLabels":28,"otherNames":29},"The starting dose for cariprazine is 1.5 mg daily in a single dose, and subsequently, after a minimum of two weeks, the dose can be increased to 3 mg and decreased again to 1.5 mg daily at the treating physician's discretion.",[15],[30],"Reagila, ATC: N05AX15",[32],{"name":33,"affiliation":34,"role":35},"René E. Nielsen, Prof, MD,PhD","Psychiatry, Aalborg University Hospital","PRINCIPAL_INVESTIGATOR",[37,43],{"name":38,"role":39,"phone":40,"phoneExt":41,"email":42},"Sanne V. Hovgesen, MD","CONTACT","+45 25487706",null,"sanne.hovgesen@rn.dk",{"name":44,"role":39,"phone":45,"phoneExt":41,"email":46},"Simon Johnsen, MsN","+45 50589034","simonjohnsen@rn.dk",[48],{"facility":5,"status":49,"city":50,"state":41,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"RECRUITING","Aalborg","9000","Denmark","DK",{"type":55,"coordinates":56},"Point",[57,58],9.9187,57.048,{"lat":58,"lon":57},[61,63],{"name":38,"role":39,"phone":62,"phoneExt":41,"email":42},"+45 29217805",{"name":64,"role":39,"phone":65,"phoneExt":41,"email":66},"Simon Johnsen","+45 61395631","simon.johnsen@rn.dk",{"type":35,"investigatorFullName":68,"investigatorTitle":69,"investigatorAffiliation":5,"oldNameTitle":41,"oldOrganization":41},"René Ernst Nielsen","MD, PhD, Professor",[71,73,76,78],{"name":72,"class":6},"Glostrup University Hospital, Copenhagen",{"name":74,"class":75},"Mental Health Department Odense, University Clinic","UNKNOWN",{"name":77,"class":75},"Psychiatric Center Copenhagen, Rigshospitalet",{"name":79,"class":6},"Psychiatric Hospital, Hillerod","100509478","phase-4-lithium-versus-cariprazine-in-the-acute-phase-treatment-of-bipolar-depression-duag9-100509478",false,"NCT05913947","Lithium Versus Cariprazine in the Acute Phase Treatment of Bipolar Depression (DUAG9)","Lithium Versus Cariprazine in the Acute Phase Treatment of Bipolar Depression: a Pragmatic Head-to-head Open, Randomized Multicenter Study: The 9th Study of the Danish University Antidepressant Group (DUAG 9)","DUAG9","Inclusion Criteria:\n\n* A diagnosis of bipolar disorder, type 1 or type 2, and a current episode of depression according to DSM-5\n* Severity of depression: A score of at least 21 on the self-reported Major Depression Inventory (MDI).\n* No start or dose increase of psychotropic medication (except for benzodiazepines and benzodiazepine-like drugs (zopiclone, zolpidem, and melatonin)) in the two weeks prior to inclusion.\n* No new start of formalized psychotherapy sessions, excluding psychoeducation, during the 4 weeks prior to inclusion.\n* Age criteria: Subjects must be at least 18 years old and below 65 at the time of randomization.\n* The duration of the current depressive episode must be between 4 and 52 weeks as judged by the investigator at the time of randomization.\n* Clinical uncertainty regarding which of the alternatives, cariprazine and lithium, would be the better choice in the specific case.\n* Female participants should be sterile or non-fertile or, in case of being fertile, they must have a negative pregnancy test AND use safe anticonception.\n* Signed document of informed consent.\n\nExclusion Criteria:\n\n* Prior or ongoing acute treatment of a depressive episode lasting \\> 14 days with either lithium or cariprazine as judged by the investigator.\n* ECT within the current depressive episode.\n* A score of MAS \\> 6.\n* A diagnosis of dementia.\n* High risk of non-adherence at the investigator's discretion.\n* Not understanding the Danish language as judged by the investigator\n* Psychiatric coercion in the form of forced admission or detainment OR sentence to forensic psychiatric care.\n* Presence of clinically relevant delusions, hallucinations or other psychotic symptoms as judged by the investigator.\n* Suicidality according to C-SSRS with a positive response to question 4 or 5 or upon investigator's discretion.\n* Medical conditions like cancer, kidney failure, epilepsy, deep brain stimulation device, or other medical conditions interfering with study the outcome and safety as judged by investigator's discretion.\n* Current harmful use or dependency of alcohol or drugs according to DSM-5.\n* Known allergy to any of the substances in the study medication.","ALL","18 Years","65 Years",{"count":92,"type":93},122,"ESTIMATED","INTERVENTIONAL",[96],"PHASE4","The goal is to study the effect of lithium compared to cariprazine in patients with depression in a bipolar disease.\n\nThe main question it aims to answer is:\n\nDifference in change between the two groups from baseline to after 8 weeks treatment on Hamilton Ratings Scale for Depression, 6-item version (HDS-6)\n\nParticipants will be randomized to treatment with either lithium or cariprazin.\n\n* Will meet for interview and ratings 4 times during study period.\n* In two meetings, there will be made blood samples and ECG. At one meeting also a Urine sample.\n* Will be contacted for telephone interviews at 6 occasions.",[99],"Depression, Bipolar","2026-01-19",{"date":102,"type":103},"2026-01-21","ACTUAL",{"date":105,"type":103},"2022-12-13",{"date":107,"type":93},"2028-09-02",{"name":5,"class":6},1]