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The LiLa-Bipolar RCT
EU CTIS ID: 2023-509607-32-00
What this study is testing
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.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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)
You likely can't join if
- Past non-response or intolerance to lamotrigine or lithium with > 6 weeks treatment at an adequate dosage
- Currently taking mod stabilizers at enrollment in CADIC
- Chronic kidney disease with GFR 0-10 ml/min
- Severe cardiac insufficiency (NYHA IIIb-IV)
- Brugadas syndrome
- Severe hypothyroidism despite treatment
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.