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REL-1017 for Depression (RELIANCE-II 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
Adults 18 to 65 years, inclusive.
Diagnosed with Major Depressive Disorder (MDD) based on Structured Clinical Interview for DSM-5 (SCID-5) for MDD.
Must not have
Severe alcohol or substance use disorder.
History of bipolar I and II disorder, psychosis, and/or mania.
Timeline
Screening 30 days
Treatment Varies
Follow Up 1 day
Awards & highlights

RELIANCE-II Trial Summary

This trial is testing whether a new drug, REL-1017, is effective and safe when used to treat Major Depressive Disorder in addition to current antidepressant therapy.

Who is the study for?
This trial is for adults aged 18-65 with Major Depressive Disorder (MDD) who are currently experiencing a depressive episode and haven't had adequate relief from 1 to 3 antidepressant treatments. Participants must be on stable first-line antidepressant therapy. It's not for those with severe substance abuse, recent opioid use, history of certain brain stimulation therapies, suicidal behavior in the past year, bipolar disorder, psychosis or prior NMDAR antagonist treatment.Check my eligibility
What is being tested?
The study tests REL-1017 as an add-on treatment for MDD against a placebo. Participants will continue their regular antidepressants and receive either REL-1017 or a placebo daily. The trial aims to see if adding REL-1017 improves depression symptoms more than just the standard treatment alone.See study design
What are the potential side effects?
While specific side effects of REL-1017 aren't listed here, common side effects of similar medications may include dizziness, nausea, headache, sleep disturbances or changes in appetite. Each person's reaction can vary.

RELIANCE-II 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.
Select...
I have been diagnosed with Major Depressive Disorder.
Select...
I am currently experiencing a major depressive episode.
Select...
I've tried 1-3 antidepressants without enough improvement.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
You have a serious problem with alcohol or drug use.
Select...
You have a history of bipolar disorder, psychosis, or mania.

RELIANCE-II Trial Timeline

Screening ~ 30 days
Treatment ~ Varies
Follow Up ~1 day
This trial's timeline: 30 days for screening, Varies for treatment, and 1 day for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
Change in CGI-S score
Change in the MADRS10 total score

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

RELIANCE-II 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
1,514 Total Patients Enrolled
6 Trials studying Depression
1,448 Patients Enrolled for Depression
Marco Pappagallo, MDStudy DirectorRelmada Therapeutics
7 Previous Clinical Trials
1,198 Total Patients Enrolled
3 Trials studying Depression
1,086 Patients Enrolled for Depression
Cedric O'Gorman, MDStudy DirectorRelmada Therapeutics
2 Previous Clinical Trials
300 Total Patients Enrolled
2 Trials studying Depression
300 Patients Enrolled for Depression

Media Library

REL-1017 Clinical Trial Eligibility Overview. Trial Name: NCT04855747 — Phase 3
Depression Research Study Groups: Placebo, REL-1017 25 mg
Depression Clinical Trial 2023: REL-1017 Highlights & Side Effects. Trial Name: NCT04855747 — Phase 3
REL-1017 2023 Treatment Timeline for Medical Study. Trial Name: NCT04855747 — Phase 3
Depression Patient Testimony for trial: Trial Name: NCT04855747 — Phase 3

Frequently Asked Questions

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

Have there been any other recent investigations surrounding REL-1017?

"There are presently 3 active studies for REL-1017 with 2 trials in Phase 3. The majority of the studies for REL-1017 are running out of Saraland, Alabama, however there are a total of 153 locations operating studies for REL-1017."

Answered by AI

What are the dangers associated with taking REL-1017?

"REL-1017 has received a Phase 3 safety score of 3 from our analysts at Power. This is because, at this stage of development, there is both efficacy data and multiple rounds of safety data available."

Answered by AI

Could I possibly join this experiment?

"The target recruitment for this trial is 400 individuals that are between 18-65 years old and have melancholia. Furthermore, it is essential that these participants also meet the following diagnostic criteria for a current major depressive episode."

Answered by AI

How many people are allowed to join this experiment?

"To run this trial, 400 individuals who fit the pre-determined profile are required. Relmada has two locations participating in the study, Site 219 in Lakeland, Florida and Site 257 in Towson, Maryland."

Answered by AI

What are the precedents for this research?

"Research for REL-1017 began in 2021 with a clinical trial sponsored by Relmada Therapeutics, Inc. After the first successful trial of 400 patients, the drug entered Phase 3 and was approved. Now, there are three ongoing studies involving REL-1017 in 95 cities across three countries."

Answered by AI

How many different places are conducting this trial?

"This trial is currently running at 46 sites, which are located in cities such as Lakeland, Towson, and Miami, among others. If you are considering participating in this trial, it may be helpful to select a clinic that is located close to minimize travel requirements."

Answered by AI

Would this experiment involve elderly individuals?

"This trial is open to patients between the ages of 18 and 65. There are 202 trials for patients under 18 and 990 trials for patients over 65."

Answered by AI

Are there any patients being accepted into this study at this time?

"Yes, the information on clinicaltrials.gov indicates that this study is currently looking for patients. The clinical trial was first posted on 2021-03-30 and was most recently edited on 2022-05-09. The study is admitting 400 participants across 46 sites."

Answered by AI

Who else is applying?

What state do they live in?
Florida
California
Texas
Other
How old are they?
18 - 65
What site did they apply to?
Relmada Site
SanRo Clinical Research Group
Relmada Site 254
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
2
0
3+

Why did patients apply to this trial?

I need help. I am very depressed. I'm tired of being tired. I’m tired of being depressed.
PatientReceived no prior treatments
Can not find a good pill to take.
PatientReceived 1 prior treatment

How responsive is this trial?

Most responsive sites:
  1. SanRo Clinical Research Group: < 24 hours
  2. Relmada Site 233: < 48 hours
  3. Relmada Site 213: < 48 hours
Average response time
  • < 2 Days
Typically responds via
Email
Phone Call
~0 spots leftby Jun 2024