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REL-1017 for Depression (RELIGHT Trial)

Verified Trial
Phase 3
Recruiting
Research Sponsored by Relmada Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Have you tried more than 1 but not more than 3 treatments for your depression that have not worked?
Be older than 18 years old
Must not have
Were you hospitalized during your most recent depressive episode?
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 28
Awards & highlights
Pivotal Trial

Summary

This trial tests REL-1017, a new drug, in people with major depression who aren't getting better with their current medication. The drug is taken regularly alongside their usual antidepressant to see if it helps improve their symptoms. REL-1017 has shown favorable safety, tolerability, and potential rapid and sustained antidepressant effects in previous trials.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Possible side effects of REL-1017 aren't detailed here but typically could include nausea, headache, dizziness, and sleep disturbances among others common in psychiatric medications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 28
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 28 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in MADRS Total Score From Baseline to Day 28

Side effects data

From 2022 Phase 3 trial • 227 Patients • NCT04688164
12%
Headache
7%
Upper respiratory tract infection
7%
Nausea
6%
Dizziness
5%
COVID-19
4%
Diarrhoea
3%
Constipation
2%
Suicidal Ideation
1%
Cholecystitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
REL-1017 25 mg
Placebo

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: REL-1017 25 mgExperimental Treatment1 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: PlaceboPlacebo Group1 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)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
REL-1017
2021
Completed Phase 3
~1220

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for depression include selective serotonin reuptake inhibitors (SSRIs), which increase serotonin levels in the brain, and serotonin-norepinephrine reuptake inhibitors (SNRIs), which boost both serotonin and norepinephrine. Tricyclic antidepressants (TCAs) and monoamine oxidase inhibitors (MAOIs) also work by altering neurotransmitter levels but are less commonly used due to side effects. NMDA receptor antagonists, such as ketamine and the investigational drug REL-1017, represent a novel approach by targeting glutamate signaling, which can rapidly alleviate depressive symptoms. This is particularly important for treatment-resistant depression, offering hope for patients who do not respond to traditional therapies.
Targeting glutamate signalling in depression: progress and prospects.Ketamine: promising path or false prophecy in the development of novel therapeutics for mood disorders?

Find a Location

Who is running the clinical trial?

Relmada Therapeutics, Inc.Lead Sponsor
8 Previous Clinical Trials
1,554 Total Patients Enrolled
6 Trials studying Depression
1,488 Patients Enrolled for Depression
Paul Greene, PhDStudy DirectorRelmada Therapeutics
1 Previous Clinical Trials
340 Total Patients Enrolled
1 Trials studying Depression
340 Patients Enrolled for Depression
Cedric O'Gorman, MDStudy DirectorRelmada Therapeutics
2 Previous Clinical Trials
340 Total Patients Enrolled
2 Trials studying Depression
340 Patients Enrolled for Depression
~151 spots leftby Dec 2025