Not recruiting

Study on the Effectiveness and Safety of REL-1017 for Patients with Major Depression Who Have Not Responded to Current Treatment

Fast replyInvestigationalNo placebo

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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 effects of a new treatment for Major Depressive Disorder (MDD), a condition characterized by persistent feelings of sadness and loss of interest. The treatment being tested is a medication called REL-1017, which contains the active ingredient dextromethadone hydrochloride. This study aims to evaluate how effective and safe REL-1017 is when used alongside existing antidepressant treatments for individuals who have not responded adequately to their current medications.

Participants in the study will be randomly assigned to receive either REL-1017 or a placebo, which looks like the real medication but does not contain the active ingredient. The study will last for 28 days, during which participants will take the medication in tablet form by mouth. Throughout the study, participants will be monitored to assess changes in their symptoms and overall well-being. The primary goal is to see if REL-1017 can help reduce symptoms of depression more effectively than the placebo.

During the trial, participants' progress will be measured using various scales and assessments, such as the Montgomery-Åsberg Depression Rating Scale (MADRS), which helps evaluate the severity of depression. The study will also look at other factors, including any side effects experienced by participants and changes in their overall health. The results of this study could provide valuable insights into the potential benefits of REL-1017 for people with Major Depressive Disorder who have not found relief with their current treatments.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, the participant will be required to provide written informed consent. This ensures understanding and agreement to participate in the trial.
Eligibility is confirmed through various assessments, including the Montgomery-Åsberg Depression Rating Scale (MADRS) and other diagnostic tools, to ensure a diagnosis of major depressive disorder (MDD) with inadequate response to current antidepressant treatment.
Step 2
Baseline assessment
On Day 1, a baseline assessment is conducted. This includes measuring the MADRS score, which should not exceed 30% and should be more than 20% compared to the screening score.
Participants must continue their current antidepressant treatment regimen, which has been stable for at least six weeks prior to this assessment.
Step 3
Medication administration
Participants will receive either the study drug, REL-1017, or a placebo. The medication is administered in the form of tablets taken orally.
The study drug contains dextromethadone hydrochloride and is taken alongside the participant's ongoing antidepressant treatment.
Step 4
Follow-up assessments
Regular assessments are conducted to monitor the participant's response to the treatment. These include evaluations on Day 7 and Day 28 using the MADRS and other scales.
The primary goal is to observe a decrease in the MADRS score from baseline to Day 28, indicating an improvement in depressive symptoms.
Step 5
Safety monitoring
Throughout the study, safety is monitored through various measures, including vital signs, physical examinations, and laboratory tests.
Potential side effects or adverse events are recorded and assessed to ensure participant safety.
Step 6
Completion of the study
The study concludes with a final assessment on Day 28. This includes a comprehensive evaluation of the participant's mental health status and any changes in symptoms.
Participants are provided with information on the next steps and any necessary follow-up care.

Who can join the trial?

11 criteria

You must provide written informed consent, which means you agree to participate after understanding the study details.
Your medical records must show a diagnosis of **Major Depression** with an inadequate response to antidepressants, confirmed by specific assessments.
Your score on a depression rating scale called **MADRS** must be 26 or higher to join the study.
Your initial **MADRS** score on the first day of the study should not be more than 30% higher or 20% lower than your score during the screening.
You must be between 18 and 65 years old.
Your **Body Mass Index (BMI)**, which is a measure of body fat based on height and weight, should be between 18.5 and 30.0.
You need to understand and be willing to follow all study requirements, including taking the study medication and attending all visits.
If you are a woman who can have children or a man with a partner who can have children, you must use a highly effective birth control method during the study and for at least 2 months after the last dose of the study drug.
You must have a diagnosis of **Major Depressive Disorder (MDD)**, confirmed by a specific interview process.
Your current depressive episode must have lasted between 8 weeks and 24 months, confirmed by specific assessments.
You must have been treated with antidepressants for at least 6 weeks before the study and have shown some improvement, but not complete recovery, while on a stable dose of medication.

Who cannot join the trial?

8 criteria

Participants who have a medical condition other than Major Depression that could interfere with the study.
Individuals who have not shown an inadequate response to ongoing Antidepressant Therapy (ADT) by Day 28.
Participants who are not within the specified age range for the study.
Individuals who are not willing or able to comply with the study procedures.
Participants who are part of a vulnerable population, which means they might need special protection or care.
Individuals who are currently participating in another clinical trial.
Participants who have a history of substance abuse or dependency that could affect the study results.
Individuals with any other condition that the study doctors believe would make it unsafe or inappropriate for them to participate.

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Verified sites

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

Verified
Azienda Ospedaliera Nazionale Ss Antonio E Biagio E C Arrigo Alessandria
Alexandria, Italy
Responsive
Azienda Ospedaliero-Universitaria Sant Andre
Rome, Italy
Responsive
Universita Degli Studi Di Roma La Sapienza
Rome, Italy

Trial locations

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Investigated drugs

REL-1017 is a medication being studied as an additional treatment for people with major depressive disorder who have not responded well to their current antidepressant therapy. The trial aims to determine if REL-1017 can improve symptoms of depression when used alongside existing treatments.

Dextromethadone Hydrochloride

What is already known about the treatment

REL-1017 – REL-1017 is administered orally and is currently being studied in clinical trials as an adjunctive treatment for major depressive disorder. It is in the phase 3 stage of clinical trials, indicating it is in the later stages of testing before potential approval for general medical use. The main therapeutic indication for REL-1017 is major depression, particularly in patients who have not responded adequately to existing antidepressant therapies. At the molecular level, REL-1017 works by modulating the NMDA receptor, which is involved in mood regulation and synaptic plasticity. It is classified pharmacologically as an NMDA receptor antagonist.

Investigated diseases

Major Depression – Major Depression, also known as Major Depressive Disorder, 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, feelings, and sense of well-being. Individuals with this disorder may experience changes in appetite, sleep disturbances, fatigue, and difficulty concentrating. The condition can lead to emotional and physical problems, impacting daily functioning. Symptoms can vary in severity and may occur in episodes, with periods of remission in between. The progression of Major Depression can differ from person to person, with some experiencing chronic symptoms and others having more episodic occurrences.