Safety of REL-1017 for Major Depressive Disorder
Launched by RELMADA THERAPEUTICS, INC. · Apr 19, 2021
Trial Information
Current as of August 21, 2025
Completed
Keywords
ClinConnect Summary
This was a multicenter, open-label, long-term study of REL-1017 to evaluate the long-term safety and long-term durability of response in patients with MDD. Patients who completed previous randomized, double-blind Phase 3 trials (NCT04688164, NCT04855747, NCT05081167) of REL-1017 as adjunctive therapy or monotherapy for MDD were asked to continue treatment with REL-1017 25 mg daily for up to 1 year. De novo patients who satisfied inclusion/exclusion criteria also were enrolled and received a 75 mg loading dose of REL-1017 on Day 1 followed by a maintenance dose of 25 mg REL-1017 daily for th...
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Adults 18 to 65 years, inclusive.
- • Diagnosed with Major Depressive Disorder (MDD) based on Structured Clinical Interview for DSM-5 (SCID-5) for MDD.
- • Current major depressive episode.
- Exclusion Criteria:
- • Any current and primary psychiatric disorder other than Major Depressive Disorder.
- • History of bipolar I and II disorder, psychosis, and/or mania.
- • Acute or chronic condition that, in the Investigator's opinion, would limit the subject's ability to complete or participate in this clinical study.
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
Phoenix, Arizona, United States
Tucson, Arizona, United States
Rogers, Arkansas, United States
Garden Grove, California, United States
Irvine, California, United States
Lemon Grove, California, United States
Torrance, California, United States
Denver, Colorado, United States
Cromwell, Connecticut, United States
Fort Myers, Florida, United States
Gainesville, Florida, United States
Jacksonville, Florida, United States
Miami Springs, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Orlando, Florida, United States
Orlando, Florida, United States
Palm Bay, Florida, United States
Pensacola, Florida, United States
Tampa, Florida, United States
Decatur, Georgia, United States
Chicago, Illinois, United States
Chicago, Illinois, United States
Boston, Massachusetts, United States
New Bedford, Massachusetts, United States
Watertown, Massachusetts, United States
Flowood, Mississippi, United States
O'fallon, Missouri, United States
Marlton, New Jersey, United States
Mount Kisco, New York, United States
New York, New York, United States
Charlotte, North Carolina, United States
Beachwood, Ohio, United States
Cincinnati, Ohio, United States
Columbus, Ohio, United States
Dayton, Ohio, United States
Oklahoma City, Oklahoma, United States
Oklahoma City, Oklahoma, United States
Oklahoma City, Oklahoma, United States
Portland, Oregon, United States
Plymouth Meeting, Pennsylvania, United States
Memphis, Tennessee, United States
Austin, Texas, United States
Austin, Texas, United States
Desoto, Texas, United States
Houston, Texas, United States
Wichita Falls, Texas, United States
Woodstock, Vermont, United States
Charlottesville, Virginia, United States
Everett, Washington, United States
Saraland, Alabama, United States
Little Rock, Arkansas, United States
Encino, California, United States
Glendale, California, United States
Imperial, California, United States
La Jolla, California, United States
Orange, 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
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
Roslindale, Massachusetts, United States
Las Vegas, Nevada, United States
Princeton, New Jersey, United States
Staten Island, New York, 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
Waukesha, Wisconsin, United States
Little Rock, Arkansas, United States
Bellflower, California, United States
Oceanside, California, United States
Redlands, California, United States
Riverside, California, United States
Santa Ana, California, United States
Upland, California, United States
Colorado Springs, Colorado, United States
Maitland, Florida, United States
Atlanta, Georgia, United States
Weldon Spring, Missouri, United States
Brooklyn, New York, United States
North Canton, Ohio, United States
North Charleston, South Carolina, United States
Memphis, Tennessee, United States
Bellaire, Texas, United States
Staten Island, New York, United States
Miami, Florida, United States
Boston, Massachusetts, United States
Watertown, Massachusetts, United States
Palm Bay, Florida, United States
Orlando, Florida, United States
Chicago, Illinois, United States
Patients applied
Trial Officials
Marco Pappagallo, MD
Study Director
Relmada Therapeutics
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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