Comparing lithium and lamotrigine for treating Bipolar II Disorder
Official title: Lithium Versus Lamotrigine in Bipolar Disorder, Type II - a Single Blinded Randomized Controlled Trial (the LiLa-Bipolar RCT)
Run by University Hospital Bispebjerg and Frederiksberg · NCT06184581 · Data updated 2026-11-12
This study is testing whether lithium or lamotrigine works better to stabilize mood in people with Bipolar II Disorder.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | University Hospital Bispebjerg and Frederiksberg Academic / other |
| Locations | 1 site (Copenhagen) |
| Status | Recruiting |
| Started | May 8, 2024 |
| Main results expected | December 1, 2027 |
| Study ends | December 1, 2027 |
| Registry record updated | March 20, 2026 |
| Trial ID | NCT06184581 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults aged 18-65 who have a confirmed diagnosis of Bipolar II Disorder and can provide informed consent.
✕Probably not a fit
Patients with a history of non-response or intolerance to lamotrigine or lithium, as well as those with severe chronic conditions, may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial aims to compare the effects of lithium carbonate and lamotrigine on mood stabilization and other important outcomes in patients diagnosed with Bipolar II Disorder. Conducted over a 6-month period, the study will utilize a randomized controlled trial design to assess the efficacy of these two commonly used medications. The research addresses a significant gap in understanding the pharmacological treatment options for Bipolar II Disorder, which is often overlooked despite its prevalence and impact on patients' lives.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into more effective treatment options for patients with Bipolar II Disorder.
How similar studies have gone: While the specific comparison of lithium and lamotrigine in Bipolar II Disorder is less studied, both medications have been widely used in treating mood disorders, suggesting potential for meaningful findings.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Bipolar disorder, type II with diagnosis confirmed by SCAN interview * Age 18-70 years * Habile (i.e., able to give informed consent) Exclusion Criteria: * 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.
Where it's running
-
Psychiatric Center Copenhagen
Copenhagen, Denmark Recruiting
Study contacts
- Study coordinator: Lars Vedel Kessing, professor, MD, DMSc.
- Email: lars.vedel.kessing@regionh.dk
- Phone: +45 38 64 70 81
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.