Lithium Versus Lamotrigine in Bipolar Disorder, Type II - a Single Blinded Randomized Controlled Trial

Study Overview
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Brief Summary
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We 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
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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. We 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.

Official Title
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Lithium Versus Lamotrigine in Bipolar Disorder, Type II - a Single Blinded Randomized Controlled Trial (the LiLa-Bipolar RCT)

Conditions
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Bipolar II Disorder

Intervention / Treatment
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* Drug: Lithium Carbonate
* Drug: Lamotrigine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Bipolar disorder, type II with diagnoses confirmed by SCAN interview Age 18-65 years Speaks and writes Danish at a level equal to mother tongue 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 Chronic kidney disease with GFR 0-10 ml/min Severe cardiac insufficiency (NYHA IIIb-IV) Brugadas syndrome Severe hypothyroidism despite treatment

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: single-blinded two-armed, parallel randomized trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lithium<br>tablet | Drug: Lithium Carbonate<br>* The trial is designed as a single-blinded two-armed, parallel randomized trial with randomization 1:1 to lamotrigine versus lithium.<br>* Other names: lithium citrate;|
| Active Comparator: Lamotrigine<br>tablet | Drug: Lamotrigine<br>* The trial is designed as a single-blinded two-armed, parallel randomized trial with randomization 1:1 to lamotrigine versus lithium.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mood stabilization | Mood Stabilization will be measured by a mood instability score reflecting the daily variability in self-monitored mood collected via the Monsenso system. | 6 (possibility of 12) months follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Non-response | Add-on of Quetiapin >50mg/day during the RCT-period | 6 (possibility of 12) months follow-up |