A Study to Assess the Efficacy and Safety of REL-1017 as Adjunctive Treatment for Major Depressive Disorder (MDD)
NCT ID: NCT04855747
Last Updated: 2025-11-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
236 participants
INTERVENTIONAL
2021-03-30
2025-01-14
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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REL-1017 25 mg
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)
REL-1017
REL-1017 tablet
Placebo
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).
Placebo
Placebo tablet
Interventions
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REL-1017
REL-1017 tablet
Placebo
Placebo tablet
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
65 Years
ALL
No
Sponsors
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Levomecor Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Paul Greene, PhD
Role: STUDY_DIRECTOR
Relmada Therapeutics
Locations
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Relmada Site
Homewood, Alabama, United States
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Chandler, Arizona, United States
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Chandler, Arizona, United States
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Phoenix, Arizona, United States
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Tucson, Arizona, United States
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Bryant, Arkansas, United States
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Anaheim, California, United States
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Bellflower, California, United States
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Encino, California, United States
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Lafayette, California, United States
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Los Angeles, California, United States
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Newport Beach, California, United States
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Orange, California, United States
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Redlands, California, United States
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Santa Ana, California, United States
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Stanford, California, United States
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Temecula, California, United States
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Upland, California, United States
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Denver, Colorado, United States
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Brandon, Florida, United States
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Hialeah, Florida, United States
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Jacksonville, Florida, United States
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Maitland, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Miami Springs, Florida, United States
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Okeechobee, Florida, United States
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Tampa, Florida, United States
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West Palm Beach, Florida, United States
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Savannah, Georgia, United States
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Boise, Idaho, United States
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Chicago, Illinois, United States
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Chicago, Illinois, United States
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Elgin, Illinois, United States
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Overland Park, Kansas, United States
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Marrero, Louisiana, United States
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Baltimore, Maryland, United States
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Bel Air, Maryland, United States
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Gaithersburg, Maryland, United States
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Boston, Massachusetts, United States
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Bloomfield Hills, Michigan, United States
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Mankato, Minnesota, United States
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Weldon Spring, Missouri, United States
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Las Vegas, Nevada, United States
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Toms River, New Jersey, United States
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Cedarhurst, New York, United States
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Monroe, North Carolina, United States
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Beachwood, Ohio, United States
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Cincinnati, Ohio, United States
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Cincinnati, Ohio, United States
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Westlake, Ohio, United States
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Philadelphia, Pennsylvania, United States
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State College, Pennsylvania, United States
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Memphis, Tennessee, United States
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Austin, Texas, United States
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Austin, Texas, United States
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Beaumont, Texas, United States
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Bellaire, Texas, United States
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Dallas, Texas, United States
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Friendswood, Texas, United States
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Houston, Texas, United States
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Sherman, Texas, United States
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Wichita Falls, Texas, United States
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Draper, Utah, United States
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Rutland, Vermont, United States
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Portsmouth, Virginia, United States
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Everett, Washington, United States
Countries
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Related Links
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Related Info
Other Identifiers
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REL-1017-302
Identifier Type: -
Identifier Source: org_study_id