The LiLa-Bipolar RCT
Key facts
- Where
- Copenhagen Nv, DániaSee the site
- Phase
- 4. fázis
Where in Dánia
- Psykiatrisk Center KobenhavnCopenhagen Nv, DániaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Region Hovedstaden
- Trial code
- EU 2023-509607-32-00
- Record updated
- 2026. március 10.
- Original description
Lithium versus Lamotrigine in bipolar disorder, type II – a single blinded randomized controlled trial (the LiLa-Bipolar RCT). To conduct a 6-month RCT comparing effects of lithium versus lamotrigine on mood stabilization and other critical patient outcomes in patients with BDII and to test whether principal effects are antimanic, antidepressant and/or prophylactic against relapse. Primary hypothesis: Lithium improves mood stabilization compared with lamotrigine.Read full original descriptionShow less
Lithium versus Lamotrigine in bipolar disorder, type II – a single blinded randomized controlled trial (the LiLa-Bipolar RCT)
Lithium versus Lamotrigine in bipolar disorder, type II – a single blinded randomized controlled trial (the LiLa-Bipolar RCT). To conduct a 6-month RCT comparing effects of lithium versus lamotrigine on mood stabilization and other critical patient outcomes in patients with BDII and to test whether principal effects are antimanic, antidepressant and/or prophylactic against relapse. Primary hypothesis: Lithium improves mood stabilization compared with lamotrigine.
Inclusion: All patients referred to the clinic as newly diagnosed with BDII will routinely be asked for inclusion in the RCT. Patients are included during 1) depressive state, 2) hypomanic state or 3) full or partial remission; Bipolar disorder, type II with diagnoses confirmed by SCAN interview; Age 18-70 years; Speaks and writes Danish or English at a level equal to mother tongue; Habile (i.e., able to give informed consent).
Exclusion: Currently taking mod stabilizers at enrollment in CADIC; Severe cardiac insufficiency (NYHA IIIb-IV); Brugadas syndrome; Chronic kidney disease with GFR 0-10 ml/min; Past non-response or intolerance to lamotrigine or lithium with > 6 weeks treatment at an adequate dosage; Severe hypothyroidism despite treatment.