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

Study acronym: DUAG9
StatusRecruiting
PhasePhase 4
Started
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Record History

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  1. Primary completion date: Sep 2024 to Sep 1, 2028
    • Study completion date: Sep 2024 to Sep 2, 2028
    • Collaborators revised (4)
    v2
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05913947
Lead Sponsor Aalborg University Hospital
Collaborators: Glostrup University Hospital, Copenhagen, Mental Health Department Odense, University Clinic, Psychiatric Center Copenhagen, Rigshospitalet, Psychiatric Hospital, Hillerod
Conditions
(from sponsor)		 Depression, Bipolar
Related terms Bipolar Disorder
Enrollment 122 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov