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NCT04688164 · ClinicalTrials.gov registry record · Phase 3
A Study to Assess the Efficacy and Safety of REL-1017 as Adjunctive Treatment for Major Depressive Disorder (MDD)
A Phase 3 study of Major Depressive Disorder, sponsored by Relmada Therapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 227
- Enrollment target
- 11
- Study locations
NCT04688164: Completed Phase 3 study of Major Depressive Disorder, sponsored by Relmada Therapeutics.
NCT04688164 is a Phase 3 study of Major Depressive Disorder that has completed, run by Relmada Therapeutics. The registered enrollment target is 227 participants, below the 376-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (40% lower). The trial reports 11 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04688164, a Phase 3 study of Major Depressive Disorder, has completed, sponsored by Relmada Therapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 227 participants
- Enrollment target
- 11
- Study locations
Study 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.
Primary Outcome
Therapeutic efficacy of REL-1017 as adjunctive treatment versus placebo in the Montgomery-Asberg Depression Rating Scale (MADRS10) A higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60 with scores above 34 indicating severe depression. A negative change from baseline indicates improvement.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG REL-1017
Study Locations (11)
Florida
- Relmada Site - Miami
- Relmada Site - Miami Springs
- Relmada Site - Palm Bay
Massachusetts
- Relmada Site - Boston
- Relmada Site - Watertown
Georgia
- Relmada Site - Decatur
Illinois
- Relmada Site - Chicago
Missouri
- Relmada Site - O'Fallon
New York
- Relmada Site - New York
Ohio
- Relmada Site - Cincinnati
Texas
- Relmada Site - Austin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 227 participants |
| Start Date | 2021-01-08 |
| Est. Completion | 2022-11-10 |
| Phase | Phase 3 |
What the finished NCT04688164 record still lists
NCT04688164 is an interventional study that assigns participants to a tested intervention. The registered 227 participants enrollment target is mid-sized for trials with a published cap, below the 376-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (40% lower).
The record links to 1 condition, with Major Depressive Disorder appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT04688164 lists 11 locations in 8 states (Florida, Massachusetts, Georgia).
Frequently Asked Questions
What is clinical trial NCT04688164 about?
NCT04688164 is a clinical study titled "A Study to Assess the Efficacy and Safety of REL-1017 as Adjunctive Treatment for Major Depressive Disorder (MDD)". 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 ...
What is the current status of trial NCT04688164?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 227 participants. The study started on 2021-01-08. Estimated completion is 2022-11-10.
What conditions does trial NCT04688164 study?
This clinical trial studies the following conditions: Major Depressive Disorder.
What interventions are being tested in trial NCT04688164?
The interventions under investigation include: Placebo (DRUG), REL-1017 (DRUG).
Who is sponsoring clinical trial NCT04688164?
This trial is sponsored by Relmada Therapeutics, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04688164 being conducted?
This trial has 11 study locations across Florida, Georgia, Illinois, Massachusetts, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04688164's enrollment target sits among peer trials
227 68th of 282 higher than 215 of 282 other Major Depressive Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Major Depressive Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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