NCT06184581RecruitingPhase 4
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)
Source: ClinicalTrials.gov · Last updated 20 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- First submitted
- 14 Dec 2023
- Start date
- 8 May 2024
- Primary completion date
- 1 Dec 2027
- Lead sponsor
- University Hospital Bispebjerg and Frederiksberg
- Diseases
- Bipolar disorder
- NCT number
- NCT06184581
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 200
- From 8 May 2024 to the primary completion date, 1 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Currently taking mood stabilizers at enrollment in CADIC
Other illness
- Severe chronic kidney disease
- Severe cardiac insufficiency
- Brugadas syndrome
Other
- Past non-response or intolerance to lamotrigine or lithium with \> 6 weeks treatment at an adequate dosage
- Severe hypothyroidism despite treatment
- Women who are pregnant, breastfeeding or planning pregnancy in near future.
Who the study is looking for
- Bipolar disorder, type II with diagnosis confirmed by SCAN interview
- Age 18-70 years
- Habile (i.e., able to give informed consent)
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Psychiatric Center Copenhagen Coordinator of this site? Confirm its status | Copenhagen | Denmark | Recruiting |
Related publications
- Lithium versus lamotrigine in bipolar disorder type II: protocol for a single-blinded, pragmatic, randomised controlled trial (the LiLa-Bipolar RCT).BMJ Open · 2026 · PMID 42103384
- Cross-sectional analysis of ongoing clinical trials involving lamotrigine for mental disorders: Insights from ClinicalTrials.gov and the EU clinical trials.Psychiatry Res · 2026 · PMID 41401709
This page is information, not medical advice. Discuss any trial with your doctor.