Recruiting

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

Verified siteInvestigational

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

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 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.

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
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.
Step 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.
Step 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.
Step 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.
Step 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 trial?

8 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 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 trial?

8 criteria

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.

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

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

Verified
Centre Hospitalier Universitaire De Nantes
Nantes, France
Verified
Centre Hospitalier Universitaire De Nimes
Nimes, France
Responsive
Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer
Barcelona, Spain

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Recruiting

Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

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.

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 as an adjunctive treatment for Major Depressive Disorder (MDD), particularly for patients who do not respond adequately to standard antidepressant therapies. The medication works by modulating neurotransmitter systems in the brain, including serotonin, dopamine, and glutamate, which are believed to play a role in mood regulation. Lumateperone is classified as an atypical antipsychotic, and its unique mechanism of action involves balancing these neurotransmitter systems to improve depressive symptoms.

Investigated diseases

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.