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Study Comparing Lithium and Cariprazine for Treating Bipolar Depression in Patients with Bipolar Type 1 or 2 During a Depressive Episode

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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 treatment of bipolar depression, a condition characterized by episodes of depression in individuals with bipolar disorder. The study compares two treatments: lithium and cariprazine. Cariprazine is also known by its code name, RGH-188. The purpose of the study is to determine which of these treatments is more effective in managing the symptoms of bipolar depression during its acute phase.

Participants in the study will receive either lithium or cariprazine, both of which are taken orally. The study will last for a period of eight weeks, during which the effects of the treatments will be monitored and compared. The effectiveness of the treatments will be assessed using a scale that measures changes in depression symptoms. This will help researchers understand how each medication impacts the condition and which might be more beneficial for patients experiencing a depressive episode in bipolar disorder.

Throughout the study, participants will be regularly evaluated to track their progress and any changes in their condition. The study aims to provide valuable insights into the treatment of bipolar depression, potentially leading to improved management strategies for those affected by this challenging condition.

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
Initial assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying a diagnosis of bipolar disorder, type 1 or 2, and ensuring the current depressive episode has lasted between 4 and 52 weeks.
A score of at least 21 on the Major Depression Inventory is required. No recent changes in psychotropic medication or psychotherapy sessions should have occurred before joining.
Step 2
Randomization
Participants are randomly assigned to receive either lithium or cariprazine for the treatment of bipolar depression.
The study aims to compare the effectiveness of these two medications in reducing symptoms of depression.
Step 3
Medication administration
Participants take the assigned medication orally. Lithium is administered in a form and dosage determined by the study protocol.
Cariprazine is provided as Reagila 1.5 mg hard capsules, taken as directed by the study team.
Step 4
Monitoring and assessments
Regular assessments are conducted to monitor the participant's response to treatment. This includes measuring changes in depression symptoms using the Hamilton Depression Scale, 6 item version.
Additional assessments may include the Hamilton Depression Scale, 17 item version, and other scales to evaluate mood and well-being.
Step 5
Follow-up visits
Participants attend scheduled follow-up visits to track progress and any side effects. These visits occur at specified intervals throughout the study.
The study team evaluates treatment compliance and any reasons for discontinuation if applicable.
Step 6
Study completion
The study concludes with a final assessment to determine the overall effectiveness of the treatment.
Participants may be asked to complete questionnaires regarding their experience and well-being at the end of the study.

Who can join the trial?

9 criteria

You must have a diagnosis of bipolar disorder, either type 1 or type 2.
Your depression must be severe, with a score of at least 21 on the Major Depression Inventory (MDI), which is a self-reported questionnaire.
You should not have started or increased the dose of any psychotropic medication (medicines that affect your mind) in the two weeks before joining, except for certain medications like benzodiazepines, zopiclone, zolpidem, and melatonin.
You should not have started any new formal psychotherapy sessions (talk therapy) in the four weeks before joining, except for psychoeducation, which is a type of therapy that helps you understand your condition better.
You must be at least 18 years old and younger than 65 at the time of joining the study.
Your current depressive episode should have lasted between 4 and 52 weeks, as determined by the study doctor.
There should be uncertainty about whether cariprazine or lithium would be the better treatment option for you.
If you are a female participant, you should be sterile or non-fertile, or if you are fertile, you must have a negative pregnancy test and use safe birth control methods.
You must sign a document to show that you understand the study and agree to participate.

Who cannot join the trial?

10 criteria

Patients who are not currently experiencing a depressive episode in bipolar disorder.
Patients who are not diagnosed with bipolar disorder type 1 or 2.
Patients who are not within the specified age range for the study.
Patients who are part of a vulnerable population, which means they might need special protection or care.
Patients who are not able to take the study medications, cariprazine or lithium, for any reason.
Patients who have other medical conditions that might interfere with the study or make it unsafe for them to participate.
Patients who are currently participating in another clinical trial.
Patients who have a history of not following medical advice or treatment plans.
Patients who are pregnant or breastfeeding.
Patients who have a known allergy or sensitivity to the study medications.

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Verified sites

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Verified
Aalborg University Hospital
Aalborg, Denmark
Verified
Hillerod Hospital
Hillerød, Denmark
Responsive
Region Midtjylland
Aarhus, Denmark

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Investigated drugs

Lithium
is a medication commonly used to treat mood disorders, such as bipolar disorder. In this trial, it is being tested to see how effective it is in treating the depressive episodes of bipolar disorder. Lithium helps to stabilize mood and reduce the severity and frequency of mood swings.
Cariprazine
is an antipsychotic medication that is also used to treat mood disorders, including bipolar disorder. In this study, it is being compared to lithium to determine which is more effective in treating the depressive episodes of bipolar disorder. Cariprazine works by affecting certain chemicals in the brain to help improve mood, thinking, and behavior.

Cariprazine

What is already known about the treatment

Lithium
Lithium is typically administered orally in tablet or capsule form. It is a well-established medication in the treatment of bipolar disorder, particularly effective in managing depressive episodes. Lithium works by stabilizing mood and reducing the frequency and severity of mood swings. It is classified as a mood stabilizer and is thought to affect neurotransmitter activity in the brain, although its exact mechanism at the molecular level is not fully understood.
Cariprazine
Cariprazine is administered orally, usually in capsule form. It is currently used in the treatment of bipolar disorder and schizophrenia, with ongoing research to evaluate its effectiveness in depressive episodes of bipolar disorder. Cariprazine acts as a partial agonist at dopamine D2 and D3 receptors, which helps to balance dopamine levels in the brain, contributing to its antipsychotic and mood-stabilizing effects. It is classified as an atypical antipsychotic.

Investigated diseases

Depressive Episode in Bipolar Disorder – This condition is characterized by a period of low mood and energy levels in individuals diagnosed with bipolar disorder. It involves feelings of sadness, hopelessness, and a lack of interest or pleasure in most activities. People may experience changes in sleep patterns, appetite, and concentration. This depressive phase can occur in both Bipolar I and Bipolar II disorders. The episodes can vary in duration and intensity, impacting daily functioning and quality of life. It is part of the cyclical nature of bipolar disorder, alternating with periods of mania or hypomania.