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)
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.
• A diagnosis of bipolar disorder, type 1 or type 2, and a current episode of depression according to DSM-5
• Severity of depression: A score of at least 21 on the self-reported Major Depression Inventory (MDI).
• 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.
• No new start of formalized psychotherapy sessions, excluding psychoeducation, during the 4 weeks prior to inclusion.
• Age criteria: Subjects must be at least 18 years old and below 65 at the time of randomization.
• The duration of the current depressive episode must be between 4 and 52 weeks as judged by the investigator at the time of randomization.
• Clinical uncertainty regarding which of the alternatives, cariprazine and lithium, would be the better choice in the specific case.
• 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.
• Signed document of informed consent.