Actively Recruiting
Lithium Versus Cariprazine in the Acute Phase Treatment of Bipolar Depression (DUAG9)
Led by Aalborg University Hospital · Updated on 2026-01-21
122
Participants Needed
1
Research Sites
298 weeks
Total Duration
On this page
Sponsors
A
Aalborg University Hospital
Lead Sponsor
G
Glostrup University Hospital, Copenhagen
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Lithium Versus Cariprazine in the Acute Phase Treatment of Bipolar Depression (DUAG9)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- A diagnosis of bipolar disorder, type 1 or type 2, with a current depressive episode according to DSM-5
- A score of at least 21 on the Major Depression Inventory (MDI) self-report
- No start or dose increase of psychotropic medication (except benzodiazepines and similar drugs) in the 2 weeks before inclusion
- No new formal psychotherapy sessions (except psychoeducation) started in the 4 weeks before inclusion
- Age between 18 and 65 years at randomization
- Current depressive episode duration between 4 and 52 weeks as judged by the investigator
- Clinical uncertainty about whether cariprazine or lithium is the better treatment option
- Female participants must be sterile, non-fertile, or if fertile, have a negative pregnancy test and use safe contraception
- Signed informed consent form
You will not qualify if you...
- Prior or ongoing acute treatment of current depressive episode lasting more than 14 days with lithium or cariprazine
- Electroconvulsive therapy (ECT) during the current depressive episode
- A Mania Rating Scale (MAS) score greater than 6
- Diagnosis of dementia
- High risk of non-adherence as judged by the investigator
- Not understanding Danish language
- Psychiatric coercion such as forced admission, detainment, or forensic psychiatric care
- Presence of delusions, hallucinations, or other psychotic symptoms
- Suicidality with positive response to C-SSRS question 4 or 5 or as judged by investigator
- Medical conditions interfering with study safety or outcome, such as cancer, kidney failure, epilepsy, or deep brain stimulation device
- Current harmful use or dependency of alcohol or drugs
- Known allergy to substances in the study medications
AI-Screening
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Trial Site Locations
Total: 1 location
1
Aalborg University Hospital
Aalborg, Denmark, 9000
Actively Recruiting
Research Team
S
Sanne V. Hovgesen, MD
CONTACT
S
Simon Johnsen, MsN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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