Study on Lumateperone for Patients with Major Depressive Disorder Not Responding to Antidepressants

3 1

What is this study about?

This clinical trial is focused on studying the effects of a medication called lumateperone in patients with Major Depressive Disorder (MDD). MDD is a mental health condition characterized by persistent feelings of sadness and loss of interest in activities. The study aims to evaluate how effective and safe lumateperone is when used alongside existing antidepressant treatments for individuals who have not responded adequately to their current medication.

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 study will last for several weeks, during which participants will take the medication daily. The main goal is to observe changes in the severity of depression symptoms over this period. The study will also monitor any side effects or safety concerns related to the treatment.

Throughout the study, participants will have regular check-ins to assess their progress and any changes in their condition. The effectiveness of the treatment will be measured by changes in specific depression rating scales, which help to quantify the severity of symptoms. This research hopes to provide valuable insights into the potential benefits of lumateperone as an additional treatment option for those struggling with MDD.

1 Initial Visit and Baseline Assessment

Upon joining the study, an initial visit is conducted to confirm eligibility. This includes a review of medical history and current medications.

A baseline assessment is performed, which involves evaluating the severity of depression using the Montgomery-Åsberg Depression Rating Scale (MADRS) and other relevant scales.

2 Randomization and Start of Treatment

Participants are randomly assigned to receive either lumateperone 42 mg or a placebo. The treatment is administered once daily.

The treatment is taken orally in the form of capsules, alongside ongoing antidepressant therapy.

3 Treatment Period

The treatment period lasts for 43 days. During this time, participants continue taking their assigned treatment daily.

Regular assessments are conducted to monitor changes in depression symptoms and overall health.

4 Final Assessment

At the end of the 43-day treatment period, a final assessment is conducted.

The primary focus is on the change in the MADRS total score from the baseline to the end of the study.

5 Follow-up and Safety Monitoring

Safety parameters, including any side effects, are monitored throughout the study.

Additional assessments may include clinical laboratory tests, vital signs, and other health evaluations.

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 male or female and must be between 18 and 65 years old.
The patient must have Major Depressive Disorder (MDD), which is a type of depression. This must be confirmed by a healthcare professional using a special interview process.
The current episode of depression must have started at least 8 weeks ago but not more than 18 months ago.
The patient must have a moderate level of depression severity, as measured by specific tests used by healthcare professionals.
The patient must have a history and medical records that confirm their depression is causing significant distress or problems in important areas of their life, like work or social activities.
The patient must currently be experiencing an inadequate response to their antidepressant treatment, meaning their symptoms have improved by less than 50%.
The patient must be taking at least the minimum effective dose of one of the following antidepressants for at least 6 weeks: citalopram, escitalopram, fluoxetine, paroxetine, sertraline, duloxetine, levomilnacipran, milnacipran, venlafaxine, desvenlafaxine, bupropion, vilazodone, or vortioxetine.

Who Cannot Join the Study?

Patients who are not diagnosed with Major Depressive Disorder cannot participate. This is a condition characterized by persistent feelings of sadness and loss of interest.
Patients who have a good response to their current antidepressant therapy are not eligible. This means if your current medication is working well, you cannot join the study.
Patients who are under 18 years old or over 65 years old cannot participate. The study is only for adults within this age range.
Patients who are pregnant or breastfeeding are not eligible to join the study.
Patients with certain other medical conditions that might interfere with the study cannot participate. This means if you have other health issues that could affect the study results, you may not be able to join.
Patients who are currently participating in another clinical trial are not eligible. This means if you are already part of another study, you cannot join this one.
Patients who have a history of substance abuse or dependence within the past year cannot participate. This refers to the misuse of drugs or alcohol.
Patients who have a known allergy or sensitivity to the study medication or similar drugs cannot participate. This means if you have had allergic reactions to similar medications, you cannot join the study.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name	City	Country
Centre Hospitalier Universitaire De Nimes	Nimes	France
Medical Center Mentalcare Ltd.	Plovdiv	Bulgaria
Medical Center Hera EOOD	Sofia	Bulgaria
Diagnostic-consultative center “Aleksandrovska” EOOD	Sofia	Bulgaria
Centre Hospitalier Universitaire De Nantes	Nantes	France
Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer	Barcelona	Spain
Hopital Beaujon	Clichy	France
Umbal – Prof. D-R Stoyan Kirkovich AD	Stara Zagora	Bulgaria
Diagnostics-Consultancy Center Mladost M Varna OOD	Varna	Bulgaria
Complejo Asistencial De Zamora Hospital Provincial De Zamora	Zamora	Spain
Dr. Ivo Natsov Outpatient Clinic For Individual Practice For Specialized Medical Care In Psychiatry ET	Cherven Bryag	Bulgaria
Medical Center Intermedica Ltd.	Sofia	Bulgaria
Ptym Txvnj Hgbiwexh Ukyptnlonpfx	Sabadell	Spain
Cmvhqa Hfjnkqgcsvl Hxjmz Lycihjn	Poitiers	France
Dptskncuo Rctwthejg	Douai	France
Rvycbpk Kxfnvwyw Jbl	Kaunas	Lithuania
Mmzmez Hiafhj Cgganu Sybjs Envx	Sofia	Bulgaria
Hayeeshz Vkex dcpvavnd	Barcelona	Spain
Mckxjfm Cvppss Mazdvyskrh Pkzeky Onr	Pleven	Bulgaria

Trial status

Country	Status	Recruitment Start
Bulgaria	Recruiting	01.02.2024
France	Recruiting	01.02.2024
Lithuania	Recruiting	01.02.2024
Spain	Recruiting	01.02.2024

Trial locations

Investigated drugs:

Lumateperone

Lumateperone is being studied as an additional treatment for patients with Major Depressive Disorder (MDD) who do not respond adequately to their current antidepressant therapy. The trial aims to determine if adding lumateperone to the existing treatment can improve symptoms of depression, as measured by a specific depression rating scale.

Major Depressive Disorder – This is a mental health condition characterized by persistent feelings of sadness, hopelessness, and a lack of interest or pleasure in activities. It can affect a person’s thoughts, behavior, and physical health, leading to changes in sleep, appetite, and energy levels. The disorder often involves episodes that can last for weeks or months, with symptoms varying in intensity. Individuals may experience difficulty concentrating, making decisions, or remembering details. Emotional symptoms can include feelings of worthlessness or excessive guilt. The progression of the disorder can vary, with some experiencing recurrent episodes and others having a single episode.

Trial ID:

2023-503836-41-00

Protocol code:

ITI-007-505

NCT ID:

NCT05850689

Trial Phase:

Therapeutic confirmatory (Phase III)

Other Trials to Consider

#1 Clinical Trials Search in Europe

Study on Lumateperone for Patients with Major Depressive Disorder Not Responding to Antidepressants

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?