2023-509607-32-00RecruitingPhase 4
The LiLa-Bipolar RCT
Lithium versus Lamotrigine in bipolar disorder, type II – a single blinded randomized controlled trial (the LiLa-Bipolar RCT)
Source: EU CTIS (euclinicaltrials.eu) · Last updated 10 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- First submitted
- 1 Dec 2023
- Start date
- 29 Apr 2024
- Lead sponsor
- Region Hovedstaden
- Diseases
- Bipolar disorder
- EU CT number
- 2023-509607-32-00
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 200
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Currently taking mod stabilizers at enrollment in CADIC
Other illness
- Severe cardiac insufficiency (NYHA IIIb-IV)
- Brugadas syndrome
Lab values
- Chronic kidney disease with GFR 0-10 ml/min
Other
- Past non-response or intolerance to lamotrigine or lithium with > 6 weeks treatment at an adequate dosage
- Severe hypothyroidism despite treatment
Who the study is looking for
- 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)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Psykiatrisk Center Kobenhavn | Copenhagen Nv | Denmark | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.