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A Study to Assess the Efficacy and Safety of REL-1017 as Adjunctive Treatment for Major Depressive Disorder (MDD)
Sponsor: Levomecor Inc.
Summary
This is an outpatient, 2-arm, Phase 3, multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of REL-1017 once daily (QD) as an adjunctive treatment of Major Depressive Disorder. Study participants will continue to take their current antidepressant therapy in addition to the study drug or placebo for the duration of the treatment period.
Official title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo- Controlled Study to Assess the Efficacy and Safety of REL-1017 as Adjunctive Treatment of Major Depressive Disorder (The RELIANCE-II Study)
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
236
Start Date
2021-03-30
Completion Date
2025-01-14
Last Updated
2026-07-10
Healthy Volunteers
No
Conditions
Interventions
REL-1017
REL-1017 tablet
Placebo
Placebo tablet
Locations (70)
Relmada Site
Homewood, Alabama, United States
Relmada Site
Chandler, Arizona, United States
Relmada Site
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
Relmada Site
Los Angeles, California, United States
Relmada Site
Newport Beach, California, United States
Relmada Site
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
Relmada Site
Denver, Colorado, United States
Relmada Site
Brandon, Florida, United States
Relmada Site
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
Relmada Site
Miami, Florida, United States
Relmada Site
Miami, Florida, United States
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Miami, Florida, United States
Relmada Site
Miami, Florida, United States
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Miami Springs, Florida, United States
Relmada Site
Okeechobee, Florida, United States
Relmada Site
Tampa, Florida, United States
Relmada Site
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
Relmada Site
Elgin, Illinois, United States
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Overland Park, Kansas, United States
Relmada Site
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
Relmada Site
Boston, Massachusetts, United States
Relmada Site
Bloomfield Hills, Michigan, United States
Relmada Site
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
Relmada Site
Cedarhurst, New York, United States
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Monroe, North Carolina, United States
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Beachwood, Ohio, United States
Relmada Site
Cincinnati, Ohio, United States
Relmada Site
Cincinnati, Ohio, United States
Relmada Site
Westlake, Ohio, United States
Relmada Site
Philadelphia, Pennsylvania, United States
Relmada Site
State College, Pennsylvania, United States
Relmada Site
Memphis, Tennessee, United States
Relmada Site
Austin, Texas, United States
Relmada Site
Austin, Texas, United States
Relmada Site
Beaumont, Texas, United States
Relmada Site
Bellaire, Texas, United States
Relmada Site
Dallas, Texas, United States
Relmada Site
Friendswood, Texas, United States
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Houston, Texas, United States
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Sherman, Texas, United States
Relmada Site
Wichita Falls, Texas, United States
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Draper, Utah, United States
Relmada Site
Rutland, Vermont, United States
Relmada Site
Portsmouth, Virginia, United States
Relmada Site
Everett, Washington, United States