Lithium Versus Cariprazine in the Acute Phase Treatment of Bipolar Depression (DUAG9)

Recruiting now · Phase 4

Conditions studied: Depression, Bipolar

In brief

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.

Key facts

Study ID

NCT05913947

Run by

Aalborg University Hospital

People needed

122

Starts

2022-12-13

Expected to finish

2028-09-02

Last updated by the study team

2026-01-21

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Prior or ongoing acute treatment of a depressive episode lasting > 14 days with either lithium or cariprazine as judged by the investigator.
• ECT within the current depressive episode.
• A score of MAS > 6.
• A diagnosis of dementia.
• High risk of non-adherence at the investigator's discretion.
• Not understanding the Danish language as judged by the investigator
• Psychiatric coercion in the form of forced admission or detainment OR sentence to forensic psychiatric care.
• 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.
• 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.
• Current harmful use or dependency of alcohol or drugs according to DSM-5.
• Known allergy to any of the substances in the study medication.

Where it is running

• Aalborg University Hospital — Aalborg, Denmark (enrolling)

Full record on ClinicalTrials.gov

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