Lithium Versus Lamotrigine in Bipolar Disorder, Type II
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Lithium Carbonate, Lamotrigine.
- Who it may be relevant to
- Registry conditions: Bipolar II Disorder. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Lithium Versus Lamotrigine in Bipolar Disorder, Type II - a Single Blinded Randomized Controlled Trial (the LiLa-Bipolar RCT)
Overview
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.
Detailed description
Although BDII is more prevalent and with a higher disease burden, including more and longer depressive episodes and lower functioning, than bipolar disorder, type I (BDI), effects of pharmacological treatment including the most frequently used drugs in clinical practice lithium and lamotrigine, is substantially understudied. 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.
Interventions
- Drug Lithium Carbonate
The trial is designed as a single-blinded two-armed, parallel randomized trial with randomization 1:1 to lamotrigine versus lithium. - Drug Lamotrigine
The trial is designed as a single-blinded two-armed, parallel randomized trial with randomization 1:1 to lamotrigine versus lithium.
Primary outcome measures
- Mood stabilization [Time frame: 6 (possibility of 12) months follow-up]
Secondary outcome measures (2)
- Non-response [Time frame: 6 (possibility of 12) months follow-up]
- Depression [Time frame: 6 months]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Denmark · 1 center
- Psychiatric Center Copenhagen — Copenhagen
Publications
- Fredskild MU, Fussing Bruun CF, Miskowiak KW, Budtz-Jorgensen E, Vinberg M, Faurholt-Jepsen M, Kessing LV. Lithium versus lamotrigine in bipolar disorder type II: protocol for a single-blinded, pragmatic, randomised controlled trial (the LiLa-Bipolar RCT). BMJ Open. 2026 May 8;16(5):e116196. doi: 10.1136/bmjopen-2026-116196. PMID 42103384
Identifiers
NCT: NCT06184581 · 2023-509607-32-00 · 10.46540/2096-00007B