Not recruiting

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

Verified siteInvestigationalNo 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 aims to evaluate the safety and effectiveness of lumateperone, which is taken in the form of capsules, in treating these manic episodes. Participants in the study will receive either lumateperone or a placebo, which looks like the lumateperone capsule but does not contain the active ingredient.

The purpose of the study is to determine how well lumateperone works in reducing the symptoms of mania over a period of three weeks. During this time, participants will take the medication daily and will be monitored by healthcare professionals. The study will compare the changes in symptoms from the beginning to the end of the three-week period to assess the medication's impact.

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 provides written informed consent.
The patient is an inpatient, aged between 18 and 75 years, diagnosed with Bipolar I Disorder, specifically experiencing a manic episode or a manic episode with mixed features.
Step 2
Screening and baseline assessment
The patient undergoes a screening process to confirm the diagnosis using a structured clinical interview.
The patient must have a Young Mania Rating Scale (YMRS) total score of 20 or higher and a score of at least 4 on specific items such as irritability and speech.
The patient is assessed for the severity of illness using the Clinical Global Impressions-Severity (CGI-S) scale, requiring a score of 4 or higher.
Step 3
Treatment phase
The patient receives either lumateperone or a placebo, administered orally in capsule form.
The dosage of lumateperone is 42 mg, taken once daily.
The treatment lasts for a period of 3 weeks.
Step 4
Monitoring and evaluation
Throughout the 3-week treatment period, the patient's symptoms are monitored.
The primary measure of effectiveness is the change in the YMRS total score from the start to the end of the 3 weeks.
Secondary evaluation includes changes in the CGI-S score over the same period.
Step 5
Completion of the study
At the end of the 3-week treatment period, the patient's participation in the study concludes.
Final assessments are conducted to evaluate the overall impact of the treatment.

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 a male or female who is staying in a hospital, and they must be between 18 and 75 years old.
The patient must have **Bipolar I Disorder**, specifically experiencing a current episode of **mania** (a period of very high energy and mood) or mania with mixed features (having both manic and depressive symptoms at the same time). This must be confirmed by a trained professional using a special interview process.
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 during the screening and baseline visits.
The patient must have at least moderate severity of illness, which is determined by a **Clinical Global Impressions-Severity (CGI-S)** total score of 4 or higher during the screening and baseline visits. This score helps assess how severe the disorder is.
The patient must have been hospitalized voluntarily before the screening visit or admitted to an inpatient unit at the first visit with a primary diagnosis of mania. This hospital admission must be due to the current manic episode and should not be more than 14 days before the screening visit.

Who cannot join the trial?

10 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.
Patients who are not within the specified age range for the study cannot participate. The age range is typically defined by the study organizers.
Patients who are not able to follow the study procedures or take the study medication as directed cannot participate.
Patients who have other medical conditions that might interfere with the study or the safety of the patient cannot participate.
Patients who are pregnant or breastfeeding cannot participate.
Patients who are currently participating in another clinical trial cannot participate.
Patients who have a history of substance abuse or dependence that might interfere with the study cannot participate.
Patients who have a known allergy or sensitivity to the study medication cannot participate.
Patients who have a history of non-compliance with medical treatment cannot participate.

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Verified sites

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

Verified
Diagnostic-consultative center “Aleksandrovska” EOOD
Sofia, Bulgaria
Verified
Institutul De Psihiatrie Socola Lasi
Iasi, Romania

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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. It is classified pharmacologically as an atypical antipsychotic.

Investigated diseases

Bipolar I Disorder (Bipolar Mania) – Bipolar I Disorder is a mental health condition characterized by extreme mood swings that include emotional highs, known as mania or manic episodes, and lows, known as depression. During a manic episode, individuals may experience elevated mood, increased energy, reduced need for sleep, and impulsive behavior. These episodes can significantly impact daily functioning and may last for a week or more. The disorder often involves periods of normal mood between episodes. It is a chronic condition that requires ongoing management.