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Study on the Effectiveness and Safety of Ademetionine Injections for Patients with Major Depressive Disorder Not Responding to Antidepressants

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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 the effectiveness and safety of a treatment called Samyr for individuals with Major Depression Disorder. Major Depression Disorder is a mental health condition characterized by persistent feelings of sadness and loss of interest in activities. The treatment being tested, Samyr, is administered as an injection and contains the active substance ademetionine. The study aims to determine if Samyr can enhance the effects of existing antidepressant medications in patients who have not experienced sufficient improvement in their symptoms.

Participants in the study will receive either the Samyr injection or a placebo injection, which is a substance with no active medication. The study is designed to compare the outcomes of these two groups to see if Samyr provides additional benefits. The trial will take place over a period of time, during which participants will continue their regular antidepressant tablet treatment. The main goal is to observe changes in the severity of depression symptoms after 7 days of treatment, using a scale known as the Montgomery-Asberg Depression Rating Scale (MADRS).

Throughout the study, participants will attend scheduled visits where their progress will be monitored. The researchers will assess changes in depression symptoms and overall well-being using various measures, including the HRDS-6 and other scales. The study is conducted in a way that ensures neither the participants nor the researchers know who is receiving the actual medication or the placebo, which helps maintain the study's objectivity. The results will help determine if Samyr is a beneficial addition to current antidepressant treatments for those with Major Depression Disorder.

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 assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying the diagnosis of major depression disorder and ensuring the current antidepressant treatment is stable.

    The Montgomery-Asberg Depression Rating Scale (MADRS) score is evaluated to establish a baseline.

  2. Step 2

    Randomization

    Participants are randomly assigned to receive either Samyr or a placebo. This process is double-blind, meaning neither the participant nor the study team knows which treatment is being administered.

  3. Step 3

    Treatment administration

    The treatment involves intramuscular injections of either Samyr (400 mg/5ml) or a placebo (saline solution).

    Injections are administered according to the study schedule, which is designed to enhance the current antidepressant treatment.

  4. Step 4

    Monitoring and assessments

    Regular visits are scheduled to monitor progress and assess the effectiveness of the treatment.

    The primary focus is on changes in the MADRS score after 7 days of treatment, with additional assessments at scheduled visits.

  5. Step 5

    Completion of study

    The study concludes with a final assessment to evaluate the overall change in depression symptoms.

    Participants' experiences and outcomes are documented for analysis.

Who can join the trial?

7 criteria

  • The patient must provide written and signed informed consent before starting any study-related procedures.
  • The patient must be between 18 and 65 years old, including both ages.
  • The patient must be able and willing to follow the study's requirements, including attending visits and completing assessments.
  • The patient must have a primary diagnosis of **Major Depression Disorder (MDD)** for at least 12 weeks, according to the **Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)**, which is a guide used by healthcare professionals to diagnose mental disorders.
  • The patient must be taking a prescribed **SSRI** (such as citalopram, escitalopram, sertraline, or paroxetine) or **SNRI** (such as venlafaxine or duloxetine) antidepressant at an approved and stable dose for at least 4 weeks before the screening. **SSRI** and **SNRI** are types of medications used to treat depression.
  • The patient must have shown a partial response to the prescribed antidepressant in the last 8 weeks before screening. A partial response means less than 50% reduction in symptoms, based on the doctor's judgment and treatment history.
  • The patient must have a **Montgomery-Asberg Depression Rating Scale (MADRS)** score of at least 22 at screening and less than 15% reduction at baseline after initial treatment. Additionally, the patient must have a MADRS score of 19 or higher at the time of randomization. The **MADRS** is a tool used to measure the severity of depression symptoms.

Who cannot join the trial?

4 criteria

  • Patients who have a different condition than Major Depression Disorders cannot participate.
  • Patients who are not within the specified age range for the study cannot participate.
  • Patients who are part of a vulnerable population, meaning they might need special protection or care, cannot participate.
  • Patients who are not eligible based on other specific criteria set by the study cannot participate.
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Investigated drugs

Samyr IM is being tested in this clinical trial as an additional treatment to help improve the effects of antidepressants in patients with major depression disorder. The goal is to see if adding Samyr IM can enhance the overall treatment and lead to better improvement in depression symptoms for those who haven't had enough relief from their current antidepressant medications.

What is already known about the treatment

Samyr – Samyr is administered through intramuscular injection and is currently being studied in clinical trials as an adjunctive treatment for major depression disorders. It is being evaluated for its potential to enhance the effects of existing antidepressant therapies in patients who have not experienced sufficient improvement. The medication is believed to work by influencing neurotransmitter activity in the brain, which may help improve mood and alleviate depressive symptoms. Samyr is classified as a psychotropic agent, and its efficacy and safety are being compared to a placebo in ongoing research.

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 how a person thinks, feels, and handles daily activities, such as sleeping, eating, or working. The disorder often involves changes in sleep patterns, appetite, energy level, concentration, daily behavior, or self-esteem. Symptoms must be present for at least two weeks for a diagnosis. The condition can vary in severity and may occur as a single episode or recur over time. It is a common disorder that can significantly impact a person's quality of life.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-513022-29-00Protocol codeMYL-1603N-3002Estimated enrolment468 patientsSponsorMylan Inc.

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