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

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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 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.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 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. Step 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. Step 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. Step 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. Step 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 trial?

7 criteria

  • 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 trial?

5 criteria

  • 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.
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Investigated drugs

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.

What is already known about the treatment

Samyr – Samyr is administered in tablet form and is taken orally. It is currently being studied in clinical trials for its effectiveness in treating Major Depression Disorder (MDD) with mild to moderate symptoms, particularly in patients who have not fully responded to other antidepressants. The main therapeutic indication for Samyr is to improve depressive symptoms when used alongside other antidepressant treatments. At the molecular level, Samyr works by influencing neurotransmitter activity in the brain, which can help improve mood and emotional balance. It is classified pharmacologically as an antidepressant.

Investigated diseases

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 detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-513019-29-00Protocol codeMYL-1603N-3001Estimated enrolment600 patientsSponsorMylan Inc.

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