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Study Comparing Lithium and Lamotrigine for Mood Stabilization in Patients with Bipolar Disorder Type II

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of two medications, lithium carbonate and lamotrigine, in individuals diagnosed with bipolar disorder, type II. Bipolar disorder is a mental health condition characterized by extreme mood swings, including emotional highs (mania or hypomania) and lows (depression). The purpose of this study is to compare how these medications help stabilize mood and prevent mood swings in patients with this condition.

Participants in the study will be randomly assigned to receive either lithium carbonate or lamotrigine. The study will last for six months, during which the effects of the medications on mood stabilization and other important health outcomes will be observed. The trial aims to determine whether lithium carbonate is more effective than lamotrigine in improving mood stability and preventing relapses into depressive or hypomanic states.

Throughout the study, participants will take the medication in tablet form by mouth. The trial is designed to be single-blinded, meaning that the participants will not know which medication they are receiving. The study will also include a placebo group to help compare the effects of the medications. The results will help to better understand the benefits and potential side effects of these treatments for managing bipolar disorder, type II.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, participation is confirmed for individuals diagnosed with bipolar disorder, type II. Eligibility includes being between 18 and 70 years old and having proficiency in Danish or English.
Participants are included during various states: depressive, hypomanic, or remission.
Step 2
Randomization and medication assignment
Participants are randomly assigned to receive either lithium carbonate or lamotrigine.
Lithium carbonate is provided as film-coated tablets, while lamotrigine is provided as regular tablets. Both medications are taken orally.
Step 3
Medication administration
The trial involves a 6-month period where the assigned medication is taken regularly. Dosage and frequency are determined by the study protocol and monitored by the research team.
Step 4
Mood monitoring
Mood stabilization is assessed using a mood instability score. Participants self-monitor their mood daily using the Monsenso system.
Step 5
Additional assessments
Secondary assessments include the Young Mania Rating Scale, Hamilton Rating Scale for Depression, and functional assessments.
Additional evaluations involve internet-based cognitive assessments, blood samples for inflammation markers, and hair cortisol level measurements.
Step 6
Completion of the trial
The trial is expected to conclude by January 31, 2027. Participants will have contributed to understanding the effects of lithium versus lamotrigine on mood stabilization in bipolar disorder, type II.

Who can join the trial?

6 criteria

Patients must be newly diagnosed with **Bipolar Disorder, Type II**. This is a mental health condition that affects mood.
The diagnosis must be confirmed by a **SCAN interview**, which is a structured interview used by professionals to assess mental health conditions.
Patients can be included if they are in a **depressive state** (feeling very down), a **hypomanic state** (feeling unusually high or irritable), or in **full or partial remission** (symptoms have improved or gone away).
Patients must be between the ages of **18 and 70 years**.
Patients must be able to speak and write **Danish or English** at a level similar to their first language.
Patients must be **habile**, meaning they are able to understand the study and give their agreement to participate.

Who cannot join the trial?

9 criteria

Patients who do not have Bipolar Disorder, Type II cannot participate. This is a specific type of mood disorder characterized by mood swings, including depressive and hypomanic episodes.
Individuals who are not within the specified age range for the study cannot participate. The age range is typically defined by the study but is not specified here.
Participants who are part of a vulnerable population, such as those unable to give informed consent, are excluded from the study.
Patients who are not able to follow the study procedures or take the study medications as required will be excluded.
Individuals with other medical conditions that might interfere with the study or pose a risk to their health if they participate will not be allowed to join.
Participants who are currently taking medications that could interfere with the study drugs, lithium or lamotrigine, will be excluded.
Patients who have a history of allergic reactions to lithium or lamotrigine cannot participate.
Individuals who are pregnant or breastfeeding are excluded from the study.
Participants who have been involved in another clinical trial recently may not be eligible to join this study.

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Psykiatrisk Center Kobenhavn
Copenhagen, Denmark

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Investigated drugs

Lithium
is a medication used in this trial to help stabilize mood in patients with bipolar disorder type II. It is being tested to see if it can effectively manage mood swings and prevent relapses. The trial aims to determine if lithium has antimanic, antidepressant, or preventive effects against mood episodes.
Lamotrigine
is another medication being tested in this trial for its ability to stabilize mood in individuals with bipolar disorder type II. The study compares lamotrigine to lithium to evaluate its effectiveness in managing mood and preventing relapses. The goal is to understand if lamotrigine can provide similar or better mood stabilization and protection against mood episodes.

What is already known about the treatment

Lithium
Lithium is typically administered orally in tablet or capsule form. It is well-established in medical literature as a treatment for mood disorders, particularly bipolar disorder. Its main therapeutic use is to stabilize mood and prevent episodes of mania and depression in individuals with bipolar disorder. At the molecular level, lithium is believed to work by affecting neurotransmitter activity and modulating signaling pathways in the brain. It is classified as a mood stabilizer.
Lamotrigine
Lamotrigine is usually taken orally in tablet form. It is recognized in medical literature as a treatment for epilepsy and bipolar disorder. Its primary therapeutic indication is to prevent mood episodes, especially depressive episodes, in bipolar disorder. Lamotrigine works by inhibiting voltage-sensitive sodium channels, which reduces the release of excitatory neurotransmitters in the brain. It is classified as an anticonvulsant and mood stabilizer.

Investigated diseases

Bipolar Disorder, Type II – This mental health condition is characterized by mood swings that include emotional highs, known as hypomanic episodes, and lows, known as depressive episodes. Unlike Bipolar Disorder, Type I, the hypomanic episodes in Type II are less severe and do not lead to full-blown mania. During hypomanic episodes, individuals may feel more energetic, talkative, and confident, but these episodes are not as extreme as manic episodes. Depressive episodes can be severe and may include feelings of sadness, hopelessness, and a lack of interest in activities. The disorder often begins in late adolescence or early adulthood and can affect daily functioning and relationships. The progression of the disorder involves alternating periods of hypomania and depression, with the potential for mood stabilization over time.