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

Last updated: February 3, 2025
Sponsor: MGGM LLC
Overall Status: Trial Not Available

Phase

3

Condition

Depression

Treatment

NMDA receptor antagonist (active drug)

Placebo

REL1017 (esmethadone HCI) (active drug)

Clinical Study ID

NCT06735079
REL-1017-305
  • Ages 18-65
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Written informed consent.

  2. Male or female participant, aged 18 to 65 years, inclusive, at Screening.

  3. Body mass index (BMI) between 18.5 and 30.0 kg/m2, inclusive, at Screening.

  4. Participant understands the study requirements, is willing and able to commit tomeet all study requirements, adhere to both approved ADT and study drug regimen, andcomplete all assessments and all scheduled visits, per Investigator judgment.

Exclusion

Exclusion Criteria:

  1. History or presence of clinically significant abnormality as assessed by physicalexamination, medical history, 12-lead ECG, vital signs, or laboratory values, whichin the opinion of the Investigator would jeopardize the safety of the participant orthe validity of the study results, including established QT prolongation, long QTsyndrome, torsades de pointes, bradyarrhythmia, ventricular tachycardia,uncompensated heart failure (greater than NYHA Class 1 CHF), uncontrolledhypokalemia, or uncontrolled hypomagnesemia.

  2. Any medical, psychiatric condition, or social context that, in the opinion of theInvestigator, is likely to unfavourably alter the risk-benefit of participant, tointerfere with protocol compliance, or to confound safety or efficacy assessments.

  3. Triplicate 12-lead ECG with average QTcF ≥450 msec, and/or a QRS interval ≥120 msecat Screening.

  4. Poorly controlled diabetes as defined by a glycosylated hemoglobin (HbA1c) >8.5% (69mmol/mol), despite standard care. (Note: re-screening of patients who has failed thescreening process due to not meeting this exclusion criterion is allowed afterdiabetes treatment adjustment and level of glycosylated hemoglobin (HbA1c) back to <8.5%)

Study Design

Treatment Group(s): 3
Primary Treatment: NMDA receptor antagonist (active drug)
Phase: 3
Study Start date:
December 27, 2024
Estimated Completion Date:
March 01, 2027

Connect with a study center

  • Mediolanum Cardio Research

    Milano, 20123
    Italy

    Site Not Available

  • Clinical Trial Unit - Ente Ospedaliero Cantonale (CTU-EOC) Area Formazione medica e Ricerca (AFRi)

    Lugano, 6900
    Switzerland

    Site Not Available

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