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REL-1017 for Depression (RELIGHT 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
Male or female outpatients, 18-65 years of age, inclusive
Currently meets DSM-5 criteria for MDD without psychotic features, based on the SCID-5-CT, with a current major depressive episode (MDE)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 28
Awards & highlights

RELIGHT Trial Summary

This trial tests if a potential new drug can help people with depression.

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.Check my eligibility
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.See study design
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.

RELIGHT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 65 years old.
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I have been diagnosed with major depression without psychosis.
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I've tried 1-3 antidepressants without enough improvement.

RELIGHT Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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
Placebo
REL-1017 25 mg

RELIGHT 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

Find a Location

Who is running the clinical trial?

Relmada Therapeutics, Inc.Lead Sponsor
8 Previous Clinical Trials
1,614 Total Patients Enrolled
6 Trials studying Depression
1,548 Patients Enrolled for Depression
Cedric O'Gorman, MDStudy DirectorRelmada Therapeutics
2 Previous Clinical Trials
400 Total Patients Enrolled
2 Trials studying Depression
400 Patients Enrolled for Depression
Marco PappagalloStudy DirectorRelmada Therapeutics

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this trial accessible to people who are older than 25?

"This study is seeking volunteers that are under the age of 65 and have attained their majority."

Answered by AI

To whom is eligibility for this clinical study open?

"This medical trial is recruiting roughly 300 participants suffering from depression and aged between 18 to 65."

Answered by AI

Is the usage of REL-1017 25 mg associated with any adverse effects?

"Data from previous clinical trials supports its efficacy and safety, leading our team at Power to rate the security of REL-1017 25 mg as a 3 on a scale ranging from 1 to 3."

Answered by AI

Is there availability to join this clinical research endeavor?

"The clinical trial is in its recruitment stage, as evidenced by the information found on clinicaltrials.gov which was first published on August 17th 2023 and subsequently modified on September 6th of the same year."

Answered by AI

How many geographical sites are currently participating in the experiment?

"This research is currently running in 14 locations, with Newport Beach, Sherman Oaks and Brandon being some of the major sites. Thus, it would be prudent to choose a trial clinic closest to you so that transportation needs are kept at a minimum."

Answered by AI

How many persons are currently enrolled in this investigation?

"Affirmative. According to the information provided on clinicaltrials.gov, this medical trial was first listed on August 17th 2023 and is currently recruiting participants with an aim of 300 enrollees across 14 sites."

Answered by AI

Who else is applying?

What site did they apply to?
Relmada Site
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

Interested in clinical trials. I’ve tried several antidepressants over the many years I have been diagnosed. Some of the meds helped temporarily, some didn’t work at all.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
Randomized, Double-Blind, Placebo-Controlled Trial of REL-1017 as Adjunctive Treatment for MDD
2023. "Randomized, Double-Blind, Placebo-Controlled Trial of REL-1017 as Adjunctive Treatment for MDD". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06011577.
All > Depression Los Angeles > Albuquerque
~140 spots leftby Dec 2024
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