A Study to Evaluate the Efficacy and Safety of REL-1017 As Adjunctive Treatment of Major Depressive Disorder (MDD)

Summary

Study Overview This clinical trial is a Phase 3 research study designed to test the safety and effectiveness of an investigational drug called REL-1017 (esmethadone HCl). The goal is to determine if REL-1017 can help people with major depressive disorder (MDD) who are already taking other antidepressant medications but have not experienced enough improvement.

Why This Study Is Important MDD is a serious condition that affects mood, cognition, motivation, energy, and daily life. Some people do not respond fully to standard antidepressants. REL-1017 is being tested as an additional treatment to see if it can improve symptoms more effectively.

Who Can Participate The study is enrolling adults diagnosed with major depressive disorder who do not have enough relief from their current antidepressant medications. Specific criteria must be met to join the study.

What Happens in the Study Participants will be randomly assigned to receive either REL-1017 or a placebo (an inactive substance) along with their current antidepressant. This process helps researchers understand the effects of the drug. Neither the participants nor the researchers will know who receives REL-1017 or the placebo during the study.

Study Details Duration: The study involves several weeks of treatment and follow-up visits. Assessments: Participants will complete health evaluations, including physical exams and questionnaires, to monitor progress and side effects.

Costs: Study-related treatments and assessments are provided at no cost to participants.

Potential Benefits and Risks Benefits: Participants may experience improvements in depressive symptoms. Risks: As with any investigational medication, there may be side effects. All participants will be closely monitored by the study team.

Conditions

• Major Depressive Disorder (MDD)

Interventions

DRUG

REL1017 (esmethadone HCI) (active drug)

REL-1017 is an investigational drug administered as an oral tablet, once daily. The dosing regimen includes a 75 mg dose on Day 1 (three tablets) in the clinic, followed by 25 mg daily (one tablet) at home from Day 2 to Day 28, with regular safety, efficacy, and tolerability assessments REL-1017 (esmethadone HCl) is under investigation as a novel NMDAR antagonist. Unlike racemic methadone, it lacks opioid-like effects such as dependency or respiratory depression. REL-1017 also lacks dissociative effects seen with more potent NMDAR antagonists such as ketamine. Finally, REL-1017 does not appear to have metabolic or neurological side effects.

DRUG

Placebo

The placebo serves as a control to evaluate the effectiveness and safety of REL-1017. It is an inactive substance that matches the active drug in appearance but contains no active ingredients. The placebo group allows researchers to compare outcomes, such as changes in depressive symptoms, with the active drug group. The double-blind design ensures neither participants nor researchers know who is receiving the active treatment or placebo, eliminating bias. The placebo also helps assess whether observed side effects are due to the drug or unrelated factors. Participants are randomly assigned to receive either REL-1017 or the placebo, both administered once daily for 28 days. This helps establish REL-1017's clinical effectiveness and safety in treating Major Depressive Disorder (MDD).

Sponsors & Collaborators

• MGGM LLC

  lead INDUSTRY

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-12-27

Primary Completion

2026-12-01

Completion

2027-03-01

FDA Drug

Yes

Countries

• Italy
• Switzerland

Study Locations