Clinical trial Recruiting at 1 site Phase 4 Interventional Ages 18 to 70

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

PhasePhase 4
Study typeInterventional
Ages18 Years to 70 Years
SexAll
Enrollment200 (estimated)
SponsorUniversity Hospital Bispebjerg and Frederiksberg
Academic / other
Locations1 site (Copenhagen)
StatusRecruiting
StartedMay 8, 2024
Main results expectedDecember 1, 2027
Study endsDecember 1, 2027
Registry record updatedMarch 20, 2026
Trial IDNCT06184581 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.