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Study on Lumateperone for Treating Manic Episodes in Bipolar I Disorder Patients

Fast replyInvestigationalNo placebo

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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 a medication called lumateperone on individuals experiencing Bipolar I Disorder, specifically during manic episodes. Bipolar I Disorder is a mental health condition characterized by extreme mood swings, including emotional highs known as mania. The study will compare the effects of lumateperone, taken as a capsule once daily, to a placebo, which looks like the lumateperone capsule but does not contain the active ingredient.

The purpose of the study is to evaluate how effective and safe lumateperone is in treating manic episodes associated with Bipolar I Disorder. Participants will be randomly assigned to receive either lumateperone or a placebo for a period of three weeks. During this time, the study will monitor changes in the participants' symptoms to determine the impact of the treatment.

Throughout the study, participants will be closely observed to ensure their safety and to assess any changes in their condition. The goal is to gather information that could help improve treatment options for those experiencing manic episodes due to Bipolar I Disorder.

The research process

The trial runs in 5 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, the patient will be required to provide written informed consent. This is a formal agreement to participate in the study after understanding its nature and potential risks.
The patient must be between the ages of 18 and 75 and have a diagnosis of bipolar I disorder with a current episode of mania or mania with mixed features.
Step 2
Screening and baseline assessment
The patient will undergo a screening process to confirm eligibility. This includes a diagnostic interview to verify the diagnosis of bipolar I disorder.
The patient must have a Young Mania Rating Scale (YMRS) total score of 20 or higher and meet other specific criteria related to the severity of symptoms.
Step 3
Randomization and treatment
The patient will be randomly assigned to receive either lumateperone or a placebo. Lumateperone is administered in a dosage of 42 mg once daily.
The treatment will last for a period of 3 weeks, during which the patient will take the assigned medication orally in capsule form.
Step 4
Monitoring and assessments
Throughout the 3-week treatment period, the patient's symptoms will be regularly monitored using the Young Mania Rating Scale (YMRS) and the Clinical Global Impressions-Severity (CGI-S) scale.
These assessments will help determine any changes in the patient's condition from the start of the study to the end of the treatment period.
Step 5
End of treatment evaluation
At the end of the 3-week treatment period, the patient will undergo a final evaluation to assess the overall change in symptoms.
The primary focus will be on the change in the YMRS total score, with secondary attention to changes in the CGI-S score.

Who can join the trial?

7 criteria

The patient must provide written informed consent, which means they agree to participate in the study after understanding what it involves.
The patient can be either male or female and must be between 18 and 75 years old.
The patient must have **Bipolar I Disorder**, specifically experiencing a current episode of mania or mania with mixed features. This can include symptoms like feeling overly excited, irritable, or having mixed feelings.
The current manic episode must have started 4 weeks or less before the first screening visit.
The patient must have a **Young Mania Rating Scale (YMRS)** total score of 20 or higher. This scale measures the severity of manic symptoms. They must also score at least 4 on two specific symptoms: irritability, speech, content, and disruptive/aggressive behavior.
The patient must have at least moderate severity of illness, shown by a **Clinical Global Impressions-Severity (CGI-S)** total score of 4 or higher. This score helps assess how severe the disorder is.
The patient must be hospitalized voluntarily before the first screening visit or admitted to an inpatient unit at the first visit due to the current manic episode. The hospital stay should not be more than 14 days before the first screening visit.

Who cannot join the trial?

9 criteria

Patients who do not have a diagnosis of Bipolar I Disorder cannot participate. Bipolar I Disorder is a mental health condition characterized by extreme mood swings, including manic episodes.
Patients who are not experiencing a manic episode or a manic episode with mixed features cannot participate. A manic episode is a period of abnormally elevated mood and high energy, often with impulsive behavior.
Patients who are not within the specified age range for the study cannot participate. The age range is typically defined by the study and may include specific age groups.
Patients who are not willing or able to comply with the study procedures cannot participate. This means they must be able to follow the instructions and attend all required appointments.
Patients who have certain medical conditions or are taking medications that might interfere with the study treatment cannot participate. This is to ensure the safety and accuracy of the study results.
Patients who are pregnant or breastfeeding cannot participate. This is to protect the health of the mother and the baby.
Patients who have a history of substance abuse or dependence within a certain time frame before the study cannot participate. Substance abuse refers to the harmful or hazardous use of substances like alcohol or drugs.
Patients who have participated in another clinical trial within a certain time frame before this study cannot participate. This is to avoid interference with the results of either study.
Patients who have a known allergy or sensitivity to the study medication or its ingredients cannot participate. An allergy is an immune system reaction to a substance that is not typically harmful.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Center for Mental Health “Prof. N. Shipkovenski” EOOD
Sofia, Bulgaria
Verified
KBC Split
Split, Croatia
Responsive
KBC Zagreb
Zagreb, Croatia

Trial locations

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Investigated drugs

Lumateperone is being studied for its effectiveness and safety in treating patients experiencing manic episodes or manic episodes with mixed features associated with Bipolar I Disorder. The trial aims to determine how well this medication can reduce symptoms of mania over a three-week period.

Lumateperone

What is already known about the treatment

Lumateperone – Lumateperone is administered orally in the form of a tablet, taken once daily. It is currently being studied in clinical trials for its effectiveness in treating manic episodes associated with Bipolar I Disorder. The medication is primarily indicated for managing symptoms of mania or mixed features in this condition. At the molecular level, lumateperone works by modulating neurotransmitter activity in the brain, particularly affecting serotonin, dopamine, and glutamate pathways, which are believed to play a role in mood regulation. It is classified pharmacologically as an atypical antipsychotic.

Investigated diseases

Bipolar I Disorder (Bipolar Mania) – This mental health condition is characterized by extreme mood swings that include emotional highs, known as mania or hypomania, and lows, known as depression. During manic episodes, individuals may feel euphoric, full of energy, or unusually irritable. These episodes can lead to impulsive behavior, rapid speech, and a decreased need for sleep. The disorder can significantly impact daily life, affecting relationships and work performance. Manic episodes may be accompanied by mixed features, where symptoms of depression occur simultaneously. The progression of the disorder varies, with episodes occurring sporadically or in rapid succession.