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

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What is this study about?

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.

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.

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.

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.

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.

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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

No sites found in this category

Other Sites

Site Name	City	Country
Centru De Evaluare Si Tratament A Toxicodependentelor Pentru Tineri Sf. Stelian	Bucharest	Romania
Diagnostic-consultative center “Aleksandrovska” EOOD	Sofia	Bulgaria
MBAL Dr. Ivan Seliminski – Sliven AD	Sliven	Bulgaria
Institutul De Psihiatrie Socola Lasi	Iasi	Romania
Multiprofile Hospital For Active Treatment Dr. Hristo Stambolski EOOD	Kazanlak	Bulgaria
Cqownc Frx Mvfpww Hvvijy Pwfol Dmd Ijxh Tizqxr Buddoe Eefc	Burgas	Bulgaria
Suzjliaw Cntdzr Dx Pcqcxfilrr Sb Npygoggntz Bdoagt	loc Sanpetru, jud Brasov	Romania

Trial status

Country	Status	Recruitment Start
Bulgaria	Not recruiting	02.01.2025
Romania	Not recruiting	02.01.2025

Trial locations

Investigated drugs:

Lumateperone

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.

Investigated diseases:

Bipolar disorder

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.

Trial ID:

2024-513037-20-00

Protocol code:

ITI-007-452

Trial Phase:

Therapeutic confirmatory (Phase III)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?