Lithium Versus Lamotrigine in Bipolar Disorder, Type II
Lithium Versus Lamotrigine in Bipolar Disorder, Type II - a Single Blinded Randomized Controlled Trial (the LiLa-Bipolar RCT)
University Hospital Bispebjerg and Frederiksberg
200 participants
May 8, 2024
INTERVENTIONAL
Conditions
Summary
The investigators want in a 6-month randomized controlled trial (RCT) to compare effects of lithium versus lamotrigine on mood stabilization and other critical patient outcomes in patients with BDII.
Eligibility
Inclusion Criteria3
- Bipolar disorder, type II with diagnosis confirmed by SCAN interview
- Age 18-70 years
- Habile (i.e., able to give informed consent)
Exclusion Criteria7
- Past non-response or intolerance to lamotrigine or lithium with > 6 weeks treatment at an adequate dosage
- Currently taking mood stabilizers at enrollment in CADIC
- Severe chronic kidney disease
- Severe cardiac insufficiency
- Brugadas syndrome
- Severe hypothyroidism despite treatment
- Women who are pregnant, breastfeeding or planning pregnancy in near future.
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Interventions
The trial is designed as a single-blinded two-armed, parallel randomized trial with randomization 1:1 to lamotrigine versus lithium.
The trial is designed as a single-blinded two-armed, parallel randomized trial with randomization 1:1 to lamotrigine versus lithium.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06184581