[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100509478":3},{"organization":4,"outcomesModule":7,"designInfo":113,"detailedDescription":119,"studyPopulation":112,"armGroups":120,"interventions":132,"overallOfficials":144,"centralContacts":149,"locations":159,"responsibleParty":179,"collaborators":182,"id":192,"slug":112,"hasResults":193,"nctId":194,"briefTitle":195,"officialTitle":196,"acronym":197,"eligibilityCriteria":198,"healthyVolunteers":193,"sex":199,"minAge":200,"maxAge":201,"enrollmentInfo":202,"targetDuration":112,"studyType":205,"phases":206,"briefSummary":208,"conditions":209,"keywords":112,"overallStatus":161,"whyStopped":112,"lastUpdateSubmitDate":211,"lastUpdatePostDateStruct":212,"startDateStruct":215,"completionDateStruct":217,"leadSponsor":219,"locationsCount":220},{"fullName":5,"class":6},"Aalborg University Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":112},[9],{"measure":10,"description":11,"timeFrame":12},"Change in Hamilton Depressions scale, version 6 (HDS-6)","The primary aim is to investigate whether cariprazine is superior to lithium or vice versa in the acute treatment of patients with bipolar type 1 or 2 in a current depressive episode measured as change on the Hamilton Depression Scale, 6 item version, HDS-6. (Values 0- 22, higher scores mean a worse outcome).","8 weeks",[14,18,21,25,28,32,35,38,41,44,47,50,53,56,59,62,65,68,72,75,78,81,84,87,90,94,97,100,103,106,109],{"measure":15,"description":16,"timeFrame":17},"Difference-in-difference for HDS-17","Difference-in-differences for secondary continuous measures: Hamilton Depression Scale, 17 item version, HDS-17. (Values 0- 52, higher scores mean a worse outcome)","Week 4 and 8",{"measure":19,"description":20,"timeFrame":12},"Difference-in-differences in HDS-6 for the PP 8 population","Difference-in-differences (baseline to 8 weeks) in HDS-6 for the PP 8 population.\n\nHamilton Depression Scale, 6 item version, HDS-6. (Values 0- 22, higher scores mean a worse outcome).",{"measure":22,"description":23,"timeFrame":24},"Between-groups difference in proportion of responders and remitters in HDS-6 Scores.","Between-groups difference in proportion of responders and remitters at week 4 and 8 in HDS-6 scores.\n\nHamilton Depression Scale, 6 item version, HDS-6. (Values 0- 22, higher scores mean a worse outcome).","Week 4 and week 8",{"measure":26,"description":27,"timeFrame":17},"Between-groups difference in proportion of responders and remitters","Between-groups difference in proportion of responders and remitters with response and remission defined by HDS-6 score without clinical relevant manic symptoms (MAS \\\u003C7) at planned or premature endpoint.\n\nHamilton Depression Scale, 6 item version, HDS-6. (Values 0- 22, higher scores mean a worse outcome).",{"measure":29,"description":30,"timeFrame":31},"Between-groups difference in the proportion of patients with 'acceptable wellbeing'","Between-groups difference in the proportion of patients with 'acceptable wellbeing', defined as the subject reporting ≥50 on the WHO-5 questionnaire at endpoint. WHO-five Well-being Index, WHO-5 (Values 0- 100, higher scores mean a better outcome).","up to 8 weeks",{"measure":33,"description":34,"timeFrame":31},"Between-groups difference in proportion of switches to mania\u002Fhypomania.","Between-groups difference in proportion of switches to mania\u002Fhypomania with or without mixed features, defined as mania\u002Fhypomania after DSM-5 or symptoms requiring treatment (switch or response occurring at any time in the study period)",{"measure":36,"description":37,"timeFrame":31},"Between-groups difference in \"(switch to mania or hypomania) \u002F (response) -ratio\",","Between-groups difference in \"(switch to mania or hypomania) \u002F (response) -ratio\", defined as the number of subjects switching to mania or hypomania (as defined above) divided by the total number of responders, including those responders switching to mania",{"measure":39,"description":40,"timeFrame":31},"Between-group differences in reason for and time to all cause treatment discontinuation","Between-group differences in reason for and time to all cause treatment discontinuation (lack of effect, lack of tolerability, lost to follow-up, or other cause).",{"measure":42,"description":43,"timeFrame":31},"Between-group difference in treatment compliance.","Between-group difference in treatment compliance. Treatment compliance is defined as the proportion of received treatments out of the planned until drop-out or end of study.",{"measure":45,"description":46,"timeFrame":31},"Between-group difference in reasons for premature discontinuation","Between-group difference for the ITT population in reasons for premature discontinuation",{"measure":48,"description":49,"timeFrame":17},"Difference-in-difference for MAS","Difference-in-differences for secondary continuous measures: MAS Bech-Rafaelsens Mania scale .(Values 0- 44, higher scores mean a worse outcome).",{"measure":51,"description":52,"timeFrame":17},"Difference-in-difference for MES","Difference-in-differences for secondary continuous measures: MES Bech-Rafaelsens Melancholia scale, MES .(Values 0- 44, higher scores mean a worse outcome).",{"measure":54,"description":55,"timeFrame":17},"Difference-in-differences for MADRS","Difference-in-differences for secondary continuous measures: MADRS Montgomery-Aaberg Depression Rating Scale, MADRS .(Values 0- 60, higher scores mean a worse outcome).",{"measure":57,"description":58,"timeFrame":17},"Difference-in-difference for YMRS","Difference-in-differences for secondary continuous measures:YMRS Young Mania Rating Scale, YMRS .(Values 0- 60, higher scores mean a worse outcome).",{"measure":60,"description":61,"timeFrame":17},"Difference-in-differences for ASRM-14","Difference-in-differences for secondary continuous measures:ASRM-14 Altman Self-Rating Mania Scale-14, .(Values 0- 56, higher scores mean a worse outcome).",{"measure":63,"description":64,"timeFrame":17},"Difference-in-differences for MDI","Difference-in-differences for secondary continuous measures:MDI Major Depression Inventory, MDI (Values 0- 58, higher scores mean a worse outcome).",{"measure":66,"description":67,"timeFrame":17},"Difference-in-differences for WHO-5 questionnaire","Difference-in-differences for secondary continuous measures: WHO-5 questionnaire.\n\nWHO-five Well-beeing Index, WHO-5 (Values 0- 100, higher scores mean a better outcome).",{"measure":69,"description":70,"timeFrame":71},"Difference-in-difference for SCIP","Difference-in-differences for secondary continuous measures: SCIP Screen for Cognitive Impairment in Psychiatry, SCIP (Values 0- 64+, higher scores mean a better outcome)","Week 8",{"measure":73,"description":74,"timeFrame":71},"Difference-in-difference for COBRA","Difference-in-differences for secondary continuous measures: COBRA Cognitive complaints in bipolar disorder Ratings assessment, COBRA, (Values 0- 48, higher scores mean a worse outcome).",{"measure":76,"description":77,"timeFrame":17},"Difference-in-difference for FAST","Difference-in-differences for secondary continuous measures: FAST Functioning Assessment Short Test, FAST (Values 0 - 72, higher scores mean a worse outcome).",{"measure":79,"description":80,"timeFrame":17},"Difference-in-difference for PSQI","Difference-in-differences for secondary continuous measures:PSQI PIttsburgh Sleep Quality Index, PSQI (Values 0 - 21, higher scores mean a worse outcome).",{"measure":82,"description":83,"timeFrame":17},"Difference-in-difference for CGI-S","Difference-in-differences for secondary continuous measures: CGI-S Clinical Global Impression Scale - Severity, CGI-S (Values 1 -7, higher scores mean a worse outcome).",{"measure":85,"description":86,"timeFrame":17},"Difference-in-difference for CGI-I","Difference-in-differences for secondary continuous measures:CGI-I Clinical Global Impression Scale - Global Improvement CGI- I (Values 1 -7, higher scores mean a worse outcome).",{"measure":88,"description":89,"timeFrame":17},"Difference-in-difference for C-SSRS","Difference-in-differences for secondary continuous measures: C-SSRS Columbia-Suicide Severity Rating Scale, C-SSRS (Values 1 - 5, higher scores mean a worse outcome).",{"measure":91,"description":92,"timeFrame":93},"Difference-in-difference for accumulated benzodiazepine dose","Difference-in-differences for secondary continuous measures: accumulated benzodiazepine dose as diazepam equivalents (DSKP)","Up to 8 weeks",{"measure":95,"description":96,"timeFrame":93},"Difference-in-difference for time to all-causes discontinuation","Difference-in-differences for secondary continuous measures: for time to all-causes discontinuation",{"measure":98,"description":99,"timeFrame":93},"Difference-in-difference for time to all-causes. all-causes study endpoint.","Difference-in-differences for secondary continuous measures: all-causes study endpoint.",{"measure":101,"description":102,"timeFrame":93},"Between-group difference in reasons for time to all cause discontinuation.","Between-group difference for the ITT population in reasons for time to all cause discontinuation.",{"measure":104,"description":105,"timeFrame":93},"Between-group difference in reasons for treatment expectation.","Between-group difference for the ITT population in reasons for treatment expectation.",{"measure":107,"description":108,"timeFrame":93},"Between-group difference in reasons for adverse events.","Between-group difference for the ITT population in reasons for adverse events.",{"measure":110,"description":111,"timeFrame":93},"Between-group difference in reasons for serious adverse events.","Between-group difference for the ITT population in reasons for serious adverse events.",null,{"allocation":114,"interventionModel":115,"interventionModelDescription":112,"primaryPurpose":116,"observationalModel":112,"timePerspective":112,"maskingInfo":117},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":118,"maskingDescription":112,"whoMasked":112},"NONE","The primary aim is to investigate whether cariprazine is superior to lithium or vice versa in the acute treatment of patients with bipolar type 1 or 2 in a current depressive episode measured as change on the Hamilton Depression Scale, 6 item version (HDS-6) from baseline to 8 weeks of treatment. Secondarily, we aimed at comparing the two study medications on various other clinically relevant variables.\n\nThese include depressive and manic symptomatology, sleep patterns, general well-being, cognitive function, social functioning and suicidal ideation.",[121,127],{"label":122,"type":123,"description":124,"interventionNames":125},"Lithium","EXPERIMENTAL","Lithium citrate from 12 mmol increased to result in af 12-hour se-lithium between 0.6 and 0.8 mmol\u002Fl",[126],"Drug: Lithium",{"label":128,"type":123,"description":129,"interventionNames":130},"Cariprazine","Cariprazine from 1.5 mg to 3 mg daily in a single dose.",[131],"Drug: Cariprazine",[133,139],{"type":134,"name":122,"description":135,"armGroupLabels":136,"otherNames":137},"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.",[122],[138],"Litarex, ATC; N05AN01",{"type":134,"name":128,"description":140,"armGroupLabels":141,"otherNames":142},"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.",[128],[143],"Reagila, ATC: N05AX15",[145],{"name":146,"affiliation":147,"role":148},"René E. Nielsen, Prof, MD,PhD","Psychiatry, Aalborg University Hospital","PRINCIPAL_INVESTIGATOR",[150,155],{"name":151,"role":152,"phone":153,"phoneExt":112,"email":154},"Sanne V. Hovgesen, MD","CONTACT","+45 25487706","sanne.hovgesen@rn.dk",{"name":156,"role":152,"phone":157,"phoneExt":112,"email":158},"Simon Johnsen, MsN","+45 50589034","simonjohnsen@rn.dk",[160],{"facility":5,"status":161,"city":162,"state":112,"zip":163,"country":164,"countryCode":165,"cosmosGeoPoint":166,"geoPoint":171,"contacts":172},"RECRUITING","Aalborg","9000","Denmark","DK",{"type":167,"coordinates":168},"Point",[169,170],9.9187,57.048,{"lat":170,"lon":169},[173,175],{"name":151,"role":152,"phone":174,"phoneExt":112,"email":154},"+45 29217805",{"name":176,"role":152,"phone":177,"phoneExt":112,"email":178},"Simon Johnsen","+45 61395631","simon.johnsen@rn.dk",{"type":148,"investigatorFullName":180,"investigatorTitle":181,"investigatorAffiliation":5,"oldNameTitle":112,"oldOrganization":112},"René Ernst Nielsen","MD, PhD, Professor",[183,185,188,190],{"name":184,"class":6},"Glostrup University Hospital, Copenhagen",{"name":186,"class":187},"Mental Health Department Odense, University Clinic","UNKNOWN",{"name":189,"class":187},"Psychiatric Center Copenhagen, Rigshospitalet",{"name":191,"class":6},"Psychiatric Hospital, Hillerod","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":203,"type":204},122,"ESTIMATED","INTERVENTIONAL",[207],"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.",[210],"Depression, Bipolar","2026-01-19",{"date":213,"type":214},"2026-01-21","ACTUAL",{"date":216,"type":214},"2022-12-13",{"date":218,"type":204},"2028-09-02",{"name":5,"class":6},1]