Life sciences · Phase 4 Trial
ClinicalTrials.gov · October 29, 2026
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Phase 4 Trial.
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Registry record from ClinicalTrials.gov (NCT05913947). This is a study registration, not published results. Lead sponsor: Aalborg University Hospital. Recruitment status: RECRUITING. Phase: PHASE4. Study type: INTERVENTIONAL. Enrollment: 122 participants (ESTIMATED). Conditions: Depression, Bipolar. Interventions: DRUG: Lithium; DRUG: Cariprazine. Primary outcome measures: Change in Hamilton Depressions scale, version 6 (HDS-6) , 8 weeks. Brief summary: The goal is to study the effect of lithium compared to cariprazine in patients with depression in a bipolar disease. The main question it aims to answer is: Difference in change between the two groups from baseline to after 8 weeks treatment on Hamilton Ratings Scale for Depression, 6-item version (HDS-6) Participants will be randomized to treatment with either lithium or cariprazin. * Will meet for interview and ratings 4 times during study period. * In two meetings, there will be made blood samples and ECG. At one meeting also a Urine sample. * Will be contacted for telephone interviews at 6 occasions.