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REL-1017 for Depression (RELIANCE-II Trial)
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.
RELIANCE-II Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowExclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:RELIANCE-II Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2022 Phase 3 trial • 227 Patients • NCT04688164RELIANCE-II Trial Design
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Who is running the clinical trial?
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- You have a mental health condition other than major depression that is your primary concern.I've tried 1-3 antidepressants without enough improvement.You have a history of bipolar disorder, psychosis, or mania.I am between 18 and 65 years old.I have been diagnosed with Major Depressive Disorder.I am currently experiencing a major depressive episode.I am currently experiencing a major depressive episode.You have a serious problem with alcohol or drug use.I have used brain stimulation treatments like ECT or VNS.I have never been in a study for or taken ketamine, esketamine, dextromethorphan, or similar drugs.
- Group 1: Placebo
- Group 2: REL-1017 25 mg
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 30 Weeks to process to see if you qualify in this trial.
- Treatment: You will receive the treatment for 28 null
- Follow Ups: You may be asked to continue sharing information regarding the trial for 1 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
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."
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."
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."
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."
Who else is applying?
What state do they live in?
How old are they?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
Why did patients apply to this trial?
How responsive is this trial?
Most responsive sites:
- SanRo Clinical Research Group: < 24 hours
- Relmada Site 233: < 48 hours
- Relmada Site 213: < 48 hours
Average response time
- < 2 Days
Typically responds via
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