Study on the Effectiveness and Safety of Ademetionine with Antidepressants for Patients with Major Depressive Disorder

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What is this study about?

This clinical trial is focused on studying Major Depressive Disorder (MDD), a condition characterized by persistent feelings of sadness and loss of interest. The study will evaluate the effectiveness and safety of a medication called Samyr (which contains the active ingredient Ademetionine) in comparison to a placebo. The trial aims to determine if Samyr, when used alongside other antidepressant treatments, can improve symptoms in patients with mild to moderate MDD.

Participants in the study will receive either Samyr or a placebo, in addition to their current antidepressant medication. The study will last for six weeks, during which the participants’ symptoms will be monitored and assessed. The goal is to see if Samyr can provide additional relief from depressive symptoms compared to the placebo.

The study is designed to be a double-blind trial, meaning neither the participants nor the researchers will know who is receiving Samyr or the placebo. This approach helps ensure that the results are unbiased and reliable. The primary focus will be on changes in the participants’ depression scores over the course of the study, using a standard scale to measure the severity of depression symptoms.

1 initial visit and consent

Upon joining the study, provide written and signed informed consent. This confirms understanding and agreement to participate in the study.

Ensure eligibility by meeting criteria such as age between 18 to 65 years, a primary diagnosis of major depressive disorder (MDD) for at least 12 weeks, and current treatment with a stable dose of an antidepressant that is not fully effective.

2 baseline assessment

Undergo a baseline assessment to confirm eligibility. This includes a Hamilton Depression Rating Scale (HDRS-17) score between 15-20, with no more than a 10% reduction in symptoms from screening to baseline.

3 randomization and medication

Participate in a randomization process to receive either the Samyr® 400 mg gastro-resistant tablet or a placebo tablet. This is in addition to the current antidepressant treatment.

Take the assigned tablet orally as directed, once daily, for a duration of six weeks.

4 weekly assessments

Attend weekly visits for assessments. These visits will monitor changes in symptoms and any side effects experienced.

Complete scales such as the Patient Global Impression (PGI) and Clinical Global Impression (CGI) to evaluate personal and clinical perspectives on symptom changes.

5 final assessment

At the end of six weeks, undergo a final assessment to measure changes in the HDRS-17 score from baseline.

Complete final evaluations using the PGI and CGI scales to assess overall treatment impact.

Who Can Join the Study?

The patient must provide a written and signed informed consent before starting any study-related procedures.
The patient must be a male or female between the ages of 18 to 65 years, including both ages.
The patient must be able and willing to follow the study requirements, including attending visits and completing assessments and scales.
The patient must have a primary diagnosis of Major Depression Disorder (MDD) for at least 12 weeks, confirmed by a specific interview called the Mini International Neuropsychiatric Interview (MINI).
The patient must be taking a prescribed SSRI (Selective Serotonin Reuptake Inhibitor) or SNRI (Serotonin-Norepinephrine Reuptake Inhibitor) antidepressant medication, such as citalopram, escitalopram, sertraline, paroxetine, fluoxetine, venlafaxine, desvenlafaxine, or duloxetine, at an approved and stable dose for at least 4 weeks before the screening. This treatment must be insufficient or ineffective.
The patient must have an inadequate response to their current antidepressant, meaning less than 50% symptom reduction, based on the investigator’s judgment and treatment history.
The patient must have a Hamilton Depression Rating Scale (HDRS-17) score between 15-20 at screening. The score at the start of the study must not be more than 20 and should not decrease by more than 10% between screening and the start of the study.

Who Cannot Join the Study?

Patients with a Hamilton Depression Rating Scale (HDRS-17) score outside the range of 15-20 cannot participate. This is a scale used to measure the severity of depression symptoms.
Patients who have more than a 10% reduction in their HDRS-17 score at the start of the study are not eligible.
Patients who have not had an inadequate response to antidepressants are excluded. This means if your current medication is working well, you cannot join.
Patients who are not between the ages of 18 and 65 cannot participate.
Patients who are part of a vulnerable population, such as those unable to give informed consent, are not eligible.

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania	Catania	Italy
ASST Fatebenefratelli Sacco	Milan	Italy
Azienda Ospedaliero-Universitaria Sant Andre	Rome	Italy
Fondazione IRCCS San Gerardo Dei Tintori	Monza	Italy
Fondazione Santa Lucia	Rome	Italy
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico	Milan	Italy
Ospedale San Raffaele S.r.l.	Milan	Italy
Aplegdy Srbdcfbro Lucfhk Do Soayyyt	Salerno	Italy
Axeigsk Sylgnfvnpnovlhg Tcwtmhwdhdxo da Prbsi	Pavia	Italy
Acxdzkr Oildfkmrgqz Neazrsmvt Sq Agglawj E Bafqvl E C Abibgz Alyrhqsqdcw	Alexandria	Italy
Atoprbz Oolmoodyylf Pkoj Gtiyuvkc Xgjhq	Bergamo	Italy
Cjzq dd Cqwo Vctxi Svl Bnmqsvwos Mzpeww Sljtz Onbudexwxny	Albese con Cassano	Italy

Trial status

Country	Status	Recruitment Start
Italy	Recruiting	22.03.2024

Trial locations

Investigated drugs:

Ademetionine

Samyr® is a medication being tested in this clinical trial for its potential to help people with major depression who have not fully responded to their current antidepressant treatments. It is used alongside other antidepressants to see if it can improve symptoms of depression. The goal is to determine if adding Samyr® to a patient’s treatment plan can make a noticeable difference in their mood and overall mental health after six weeks of use.

Major Depressive Disorder – Major Depressive Disorder is a mental health condition characterized by persistent feelings of sadness and a lack of interest in activities once enjoyed. It affects how a person feels, thinks, and handles daily activities, such as sleeping, eating, or working. The disorder can lead to a variety of emotional and physical problems, making it difficult to function at work and home. Symptoms may include changes in appetite or weight, sleep disturbances, loss of energy, and difficulty concentrating. The progression of the disorder can vary, with some individuals experiencing episodes that last for weeks or months. Over time, these episodes can become more frequent or severe if not addressed.

Trial ID:

2024-513019-29-00

Protocol code:

MYL-1603N-3001

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Effectiveness and Safety of Ademetionine with Antidepressants for Patients with Major Depressive Disorder

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?