A Study to Assess the Efficacy and Safety of REL-1017 as Adjunctive Treatment for Major Depressive Disorder (MDD)
Launched by RELMADA THERAPEUTICS, INC. · Apr 19, 2021
Trial Information
Current as of July 09, 2025
Terminated
Keywords
ClinConnect Summary
This clinical trial is studying a medication called REL-1017 to see if it can help people with Major Depressive Disorder (MDD) who are already taking an antidepressant but still feel depressed. It is a Phase 3 study, meaning it’s one of the final steps before the treatment could be approved for wider use. Participants will take REL-1017 or a placebo (a non-active pill) once a day, while continuing their regular antidepressant treatment for the duration of the study.
To be eligible for this trial, participants must be between the ages of 18 and 65, have a body mass index (BMI) within a certain range, and have been diagnosed with MDD. They should also be currently experiencing a major depressive episode and have not responded well to 1 to 3 previous treatments. However, individuals with other serious mental health disorders, severe substance use issues, or certain medical conditions may not qualify. Throughout the study, participants will be monitored for the medication’s effectiveness and safety, helping to determine if REL-1017 is a beneficial addition to existing treatments for depression.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Body mass index (BMI) between 18.0 and 35.0 kg/m2.
- • Diagnosed with Major Depressive Disorder (MDD) based on Structured Clinical Interview for DSM-5 (SCID-5) for MDD.
- • Current Major Depressive Episode (MDE).
- • Treated on approved, stable first-line anti-depressant therapy with inadequate response to 1 to 3 valid courses of treatment with a depressant medication in the current MDE.
- Exclusion Criteria:
- • Any current and primary psychiatric disorder other than Major Depressive Disorder.
- • Severe alcohol or substance use disorder.
- • History of bipolar I and II disorder, psychosis, and/or mania.
- • Poorly controlled diabetes as defined by HbA1c \> 7.5%, despite standard care. Subjects with HbA1c \>7.5% may continue in the study if approved by the Relmada Medical Monitor.
- • Having received ketamine or esketamine within 60 days prior to Screening.
About Relmada Therapeutics, Inc.
Relmada Therapeutics, Inc. is a clinical-stage biotechnology company focused on developing innovative therapies for the treatment of chronic pain and central nervous system disorders. With a robust pipeline of novel drug candidates, Relmada leverages advanced scientific research and clinical expertise to address unmet medical needs in pain management and related conditions. The company is committed to improving patient outcomes through the development of safe and effective treatments, utilizing a patient-centric approach and fostering collaborations within the healthcare community to advance its mission.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Saraland, Alabama, United States
Little Rock, Arkansas, United States
Encino, California, United States
Glendale, California, United States
Imperial, California, United States
La Habra, California, United States
La Jolla, California, United States
Orange, California, United States
San Diego, California, United States
Santa Ana, California, United States
Norwich, Connecticut, United States
Hallandale Beach, Florida, United States
Lake City, Florida, United States
Lakeland, Florida, United States
Lauderhill, Florida, United States
Maitland, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Orange City, Florida, United States
Tampa, Florida, United States
West Palm Beach, Florida, United States
Grayson, Georgia, United States
Savannah, Georgia, United States
Boise, Idaho, United States
Prairie Village, Kansas, United States
Shawnee Mission, Kansas, United States
Owensboro, Kentucky, United States
Gaithersburg, Maryland, United States
Towson, Maryland, United States
Roslindale, Massachusetts, United States
Las Vegas, Nevada, United States
Princeton, New Jersey, United States
New York, New York, United States
Staten Island, New York, United States
Fayetteville, North Carolina, United States
Shelby, North Carolina, United States
Cincinnati, Ohio, United States
Middleburg Heights, Ohio, United States
Oklahoma City, Oklahoma, United States
Allentown, Pennsylvania, United States
Baytown, Texas, United States
Dallas, Texas, United States
Houston, Texas, United States
Plano, Texas, United States
Red Oak, Texas, United States
Waukesha, Wisconsin, United States
Stanford, California, United States
Saraland, Alabama, United States
Encino, California, United States
Glendale, California, United States
Imperial, California, United States
La Jolla, California, United States
Orange, California, United States
San Diego, California, United States
Stanford, California, United States
Norwich, Connecticut, United States
Hallandale Beach, Florida, United States
Lake City, Florida, United States
Lakeland, Florida, United States
Miami, Florida, United States
Orange City, Florida, United States
Winter Park, Florida, United States
Savannah, Georgia, United States
Boise, Idaho, United States
Gaithersburg, Maryland, United States
Las Vegas, Nevada, United States
Princeton, New Jersey, United States
New York, New York, United States
Staten Island, New York, United States
Cincinnati, Ohio, United States
Middleburg Heights, Ohio, United States
Allentown, Pennsylvania, United States
Dallas, Texas, United States
Houston, Texas, United States
Culver City, California, United States
Baltimore, Maryland, United States
Newport Beach, California, United States
Brandon, Florida, United States
Jacksonville, Florida, United States
Toms River, New Jersey, United States
Cedarhurst, New York, United States
Bellaire, Texas, United States
Wichita Falls, Texas, United States
Draper, Utah, United States
Lafayette, California, United States
Okeechobee, Florida, United States
Tampa, Florida, United States
Memphis, Tennessee, United States
Friendswood, Texas, United States
Phoenix, Arizona, United States
Bryant, Arkansas, United States
Bellflower, California, United States
Redlands, California, United States
Temecula, California, United States
Torrance, California, United States
Upland, California, United States
Denver, Colorado, United States
Hialeah, Florida, United States
Miami Springs, Florida, United States
Miami, Florida, United States
West Palm Beach, Florida, United States
Chicago, Illinois, United States
Overland Park, Kansas, United States
Gaithersburg, Maryland, United States
Boston, Massachusetts, United States
Boston, Massachusetts, United States
Watertown, Massachusetts, United States
O'fallon, Missouri, United States
Weldon Spring, Missouri, United States
Staten Island, New York, United States
Beachwood, Ohio, United States
Cincinnati, Ohio, United States
West Chester, Ohio, United States
Austin, Texas, United States
Baytown, Texas, United States
Houston, Texas, United States
Plano, Texas, United States
Bellevue, Washington, United States
Everett, Washington, United States
Waukesha, Wisconsin, United States
Homewood, Alabama, United States
Anaheim, California, United States
Mankato, Minnesota, United States
Philadelphia, Pennsylvania, United States
Rutland, Vermont, United States
Maitland, Florida, United States
Chandler, Arizona, United States
Tucson, Arizona, United States
Los Angeles, California, United States
Santa Ana, California, United States
Savannah, Georgia, United States
Chicago, Illinois, United States
Elgin, Illinois, United States
Marrero, Louisiana, United States
Bel Air, Maryland, United States
Bloomfield Hills, Michigan, United States
Las Vegas, Nevada, United States
Monroe, North Carolina, United States
Westlake, Ohio, United States
State College, Pennsylvania, United States
Beaumont, Texas, United States
Sherman, Texas, United States
Portsmouth, Virginia, United States
Patients applied
Trial Officials
Paul Greene, PhD
Study Director
Relmada Therapeutics
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Similar Trials