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

Depression, Bipolar Clinical Trial

Official title: 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)

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

The primary aim is to investigate whether cariprazine is superior to lithium or vice versa in the acute treatment of patients with bipolar type 1 or 2 in a current depressive episode measured as change on the Hamilton Depression Scale, 6 item version (HDS-6) from baseline to 8 weeks of treatment. Secondarily, we aimed at comparing the two study medications on various other clinically relevant variables.

These include depressive and manic symptomatology, sleep patterns, general well-being, cognitive function, social functioning and suicidal ideation. ;

Related Conditions & MeSH terms

• Bipolar Disorder
• Depression
• Depression, Bipolar
• Depressive Disorder

• NCT number: NCT05913947
• Study type: Interventional
• Source: Aalborg University Hospital
• Contact: Sanne V. Hovgesen, MD
• Phone: +45 25487706
• Email: sanne.hovgesen@rn.dk
• Status: Recruiting
• Phase: Phase 4
• Start date: December 13, 2022
• Completion date: September 2024