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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 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.

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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.

Conditions Studied

Major Depressive Disorder

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

FieldValue
Enrollment Target 227 participants
Start Date 2021-01-08
Est. Completion 2022-11-10
Phase Phase 3

Sponsor

Relmada Therapeutics

4 total trials

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What the Registry Record Tells You About NCT04688164

The ClinicalTrials.gov registry entry for NCT04688164 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 227 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 376-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (40% lower). The listed sponsor is Relmada Therapeutics, which has 4 total studies on file at ClinicalTrials.gov.

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 reports 11 study locations spanning 8 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.