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)

What this Trial Is About

Researchers are evaluating the effects of lithium compared to cariprazine in adults with bipolar disorder experiencing a current depressive episode. The main focus is to see the difference in improvement on the Hamilton Depression Scale, 6-item version (HDS-6), from the start of treatment to after 8 weeks. The study also compares these medications on other important factors like mood symptoms, sleep, cognitive function, social functioning, and suicidal thoughts. Participants will be randomly assigned to receive either lithium or cariprazine. Lithium treatment starts at 12 mmol once daily before bedtime and may be adjusted to maintain specific blood levels. Cariprazine begins at 1.5 mg daily with possible adjustment to 3 mg after at least two weeks. The study lasts 8 weeks, during which participants have scheduled visits for interviews, ratings, blood samples, ECGs, and urine samples. Telephone interviews are also conducted six times throughout the study. During the study, participants will attend four visits for interviews and assessments, including blood tests and heart monitoring. They will also participate in six telephone interviews. Researchers will measure changes in depression scores and other clinical outcomes. Safety and treatment adherence will be monitored closely. The trial runs until September 2028, allowing thorough assessment of both treatments over the acute phase of bipolar depression.

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