Comparing Lithium and Lamotrigine Tablets for Treating Bipolar Disorder Type II in a 6-Month Randomized Trial

What this Trial Is About

Researchers are evaluating the effects of lithium versus lamotrigine on mood stabilization and other important outcomes in patients with Bipolar Disorder, Type II BDII. This randomized controlled trial RCT addresses the need for more knowledge about pharmacological treatments for BDII, which has a higher disease burden and more depressive episodes than Bipolar Disorder, Type I. The study is sponsored by University Hospital Bispebjerg and Frederiksberg and focuses on comparing these two commonly used drugs. The trial is a single-blinded, two-armed, parallel randomized study where participants are randomly assigned in a 11 ratio to receive either lithium carbonate or lamotrigine tablets. Treatment will be administered over a period of six months, with the possibility of extending follow-up to twelve months to evaluate longer-term effects. Both drugs represent active treatments being assessed for their impact on mood stabilization and patient outcomes. Participants will be involved for at least six months, during which researchers will monitor mood stabilization as the primary outcome. Secondary outcomes include non-response to treatment and levels of depression at six months. The study includes regular assessments to track these outcomes and ensure safety. Participants eligible for the study are adults aged 18 to 70 years with confirmed BDII diagnosis and the ability to give informed consent.

Lithium Versus Lamotrigine in Bipolar Disorder, Type II