A Study to Assess the Efficacy and Safety of REL-1017 as Monotherapy for Major Depressive Disorder (MDD)
NCT ID: NCT05081167
Last Updated: 2024-03-26
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
232 participants
INTERVENTIONAL
2021-06-02
2022-09-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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REL-1017
A 75 mg REL-1017 loading dose (three 25 mg REL-1017 tablets) will be administered on Day-1 of the 28-day treatment period. From Day-2 to Day-28, participants will take 25 mg REL-1017.
REL-1017
REL-1017 tablet
Placebo
Three tablets of matching placebo will be administered on Day-1 of the 28-day treatment period. From Day-2 to Day-28, participants will take 1 placebo tablet.
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 Diagnostic and Statistical Manual of Mental Disorders, DSM-5 (SCID-5) for MDD.
* Current major depressive episode.
Exclusion Criteria
* Severe alcohol or substance use 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.
* Prior participation in a ketamine, esketamine, dextromethorphan or any other NMDAR- antagonist study, or received esketamine at any time.
18 Years
65 Years
ALL
No
Sponsors
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Relmada Therapeutics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Marco Pappagallo, MD
Role: STUDY_DIRECTOR
Relmada Therapeutics
Locations
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Relmada Site
Maitland, Florida, United States
Relmada Site
Miami, Florida, United States
Relmada Site
Miami, Florida, United States
Relmada Site
Miami Springs, Florida, United States
Relmada Site
Orlando, Florida, United States
Relmada Site
Palm Bay, Florida, United States
Relmada Site
Chicago, Illinois, United States
Relmada Site
Boston, Massachusetts, United States
Relmada Site
Watertown, Massachusetts, United States
Relmada Site
Austin, Texas, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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Study Homepage
Other Identifiers
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REL-1017-303
Identifier Type: -
Identifier Source: org_study_id
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