REL-1017 for Depression

(RELIGHT Trial)

No longer recruiting at 1 trial location

Overseen By Senior Vice President

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Relmada Therapeutics, Inc.

Disqualifiers: Psychiatric hospitalization, Significant health conditions, Suicide risk, Pregnancy, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 4

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called REL-1017 for individuals with major depressive disorder (MDD). The aim is to determine if REL-1017, when combined with current antidepressants, reduces depression symptoms more effectively than a placebo (a look-alike pill with no active ingredient). Participants suitable for this trial have been diagnosed with MDD and have not experienced sufficient improvement from 1 to 3 different antidepressant treatments. The trial will last 28 days, and researchers aim to discover a more effective way to manage depression symptoms. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking treatment for MDD.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial organizers or your doctor for guidance.

Is there any evidence suggesting that REL-1017 is likely to be safe for humans?

Research has shown that REL-1017 has been tested for safety in people with major depressive disorder (MDD). In a year-long study, participants took REL-1017 once a day, either alone or with other depression treatments. The study found that REL-1017 was generally well-tolerated.

Another study found that patients who took REL-1017 experienced improvements in their depression symptoms, with some feeling better as soon as seven days. These studies found no serious safety issues.

Participants in previous trials also reported mood improvements and enhancements in memory and attention. This suggests that REL-1017 might not only help with depression symptoms but is also safe to use.

In summary, current research supports that REL-1017 is generally safe and well-tolerated in people with MDD. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for depression?

Unlike the standard antidepressants that commonly target serotonin, norepinephrine, or dopamine, REL-1017 offers a fresh approach by acting on NMDA receptors in the brain. This is particularly exciting because it opens up a new pathway for potentially alleviating depression symptoms. Researchers are enthusiastic about REL-1017 because it could work faster than traditional antidepressants, which often take weeks to show effects. Additionally, its novel mechanism might provide relief for individuals who haven't responded to existing treatments.

What evidence suggests that REL-1017 might be an effective treatment for depression?

Research has shown that REL-1017, also known as esmethadone, might help treat major depressive disorder (MDD). One study found that 26.6% of new patients felt much better after just one week. By the end of the first month, this number grew to 51%, and it continued to increase, reaching 63.4% after six months. Another study found that patients improved their depression scores by 50% or more. In this trial, participants will receive either REL-1017 or a placebo in addition to their ongoing antidepressant. These results suggest that REL-1017 could be a promising option for people whose current antidepressants aren't working well enough. ^{2 3 4 6 7}

Who Is on the Research Team?

Paul Greene, PhD

Principal Investigator

Relmada Therapeutics

Are You a Good Fit for This Trial?

This trial is for adults aged 18-65 with major depressive disorder (MDD) who haven't had enough improvement from 1 to 3 antidepressant treatments. They must not be hospitalized for MDD currently, pregnant, or at high risk of suicide as judged by the investigator.

Inclusion Criteria

Have you tried more than 1 but not more than 3 treatments for your depression that have not worked?

Inadequate response to 1 to 3 adequate antidepressant treatments in the current MDE

I have been diagnosed with major depression without psychosis.

Exclusion Criteria

Were you hospitalized during your most recent depressive episode?

Pregnant or planning to become pregnant

I have been hospitalized for depression recently.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive REL-1017 or placebo once daily for 4 weeks as an adjunctive treatment to their ongoing antidepressant therapy

4 weeks

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• REL-1017

Trial Overview The study tests REL-1017 against a placebo in people with MDD. Participants are randomly assigned to either get the real drug or a fake one without knowing which they're getting, to fairly measure the drug's effects.

How Is the Trial Designed?

Group I: REL-1017 25 mg Experimental Treatment 1 Intervention

During the double blind treatment period (28 days), participants will take 1 tablet of REL-1017 25 mg, orally, per day in addition to their ongoing antidepressant (ADT)

Group II: Placebo Placebo Group 1 Intervention

During the double blind treatment period (28 days), participants will take 1 tablet of placebo, orally, per day in addition to their ongoing antidepressant (ADT)

Who Is Running the Clinical Trial?

Relmada Therapeutics, Inc.

Lead Sponsor

Trials

9

Recruited

1,500+

Levomecor Inc.

Lead Sponsor

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38917366/

Efficacy and Safety of Esmethadone (REL-1017) in ... Esmethadone showed stronger efficacy in PP than in ITT analyses, with the discrepancy not attributable to AEs impacting treatment adherence.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04688164

A Study to Assess the Efficacy and Safety of REL-1017 as ... Response rate is defined as an improvement ≥50% compared with total Baseline MADRS10 score.

3. relmada.com relmada.com/for-investors/news/detail/285/relmada-therapeutics-announces-efficacy-and-safety-results

Relmada Therapeutics Announces Efficacy and Safety ... When treated with REL-1017, 26.6% of de novo patients achieved clinical response by Day 7, 51.0% by Month 1, 60.7% by Month 3, 63.4% by Month 6, ...

4. psychiatrist.com psychiatrist.com/jcp/esmethadone-rel-1017-major-depressive-disorder-antidepressant-tachyphylaxis-post-hoc-analysis-phase-3-rct/

Esmethadone (REL-1017) in Patients With Major ... Esmethadone may be a potentially safe and effective adjunctive treatment for patients with MDD and antidepressant tachyphylaxis.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT04855747

A Study to Assess the Efficacy and Safety of REL-1017 as ... A higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. A negative change from baseline indicates improvement.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04855760

Safety of REL-1017 for Major Depressive Disorder This was a 1-year, multicenter, open-label, long-term study to assess the safety of REL-1017 once daily (QD) as monotherapy or as adjunctive treatment of Major ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36821775/

Subanalysis of Subjective Cognitive Measures From a ... In a Phase 2a clinical trial, REL-1017 improved subjective measures of cognitive impairment, in addition to improving total MADRS and SDQ scores.