Actively Recruiting
Led by University Hospital Bispebjerg and Frederiksberg · Updated on 2026-03-20
200
Participants Needed
1
Research Sites
N/A
Total Duration
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 1:1 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.
CONDITIONS
Lithium Versus Lamotrigine in Bipolar Disorder, Type II
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 months
Participants receive either lithium or lamotrigine tablets to stabilize mood and manage bipolar disorder, type II symptoms.
Regular visits during the 6-month treatment period
Total: 1 location
1
Psychiatric Center Copenhagen
Copenhagen, Denmark
Actively Recruiting
L
Lars Vedel Kessing, professor, MD, DMSc.
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Mette Ungermann Fredskild, Caroline Fussing Fussing Bruun, Kamilla Woznica Miskowiak...
https://pubmed.ncbi.nlm.nih.gov/42103384