Comparing Lithium and Cariprazine for Depression in Bipolar Disorder
Compares lithium with cariprazine in adults with bipolar depression, randomly assigned to one.
Plain-language title generated from the registry record
Registry title: Lithium Versus Cariprazine in the Acute Phase Treatment of Bipolar Depression (DUAG9)
Key facts
- Where
- Aalborg, Aarhus N, and Hilleroed, DenmarkSee the 3 sites
- Phase
- Phase 4
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT05913947, who can take part
Where in Denmark
- Aalborg University HospitalAalborg, DenmarkTaking people
- Region MidtjyllandAarhus N, DenmarkTaking people
- Psykiatrisk Center NordsjaellandHilleroed, DenmarkTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Aalborg University Hospital
- Trial code
- NCT05913947EU 2024-517170-20-01
- Record updated
- 29 October 2026
- Original description
The goal is to study the effect of lithium compared to cariprazine in patients with depression in a bipolar disease.Read full original descriptionShow less
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.
Inclusion: 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.
Exclusion: Prior or ongoing acute treatment of a depressive episode lasting > 14 days with either lithium or cariprazine as judged by the investigator; Current harmful use or dependency of alcohol or drugs according to DSM-5; A diagnosis of dementia; Psychiatric coercion in the form of forced admission or detainment OR sentence to forensic psychiatric care; 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; Known allergy to any of the substances in the study medication; ECT within the current depressive episode; A score of MAS > 6; High risk of non-adherence at the investigator's discretion; Not understanding the Danish language as judged by the investigator; Presence of clinically relevant delusions, hallucinations or other psychotic symptoms as judged by the investigator; Suicidality according to C-SSRS with a positive response to question 4 or 5 or upon investigator's discretion.