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Completed Phase 3 Interventional Results available

A Study to Assess the Efficacy and Safety of REL-1017 as Monotherapy for Major Depressive Disorder (MDD)

ClinicalTrials.gov ID: NCT05081167

Public ClinicalTrials.gov record NCT05081167. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 2, 2026, 3:43 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of REL-1017 Monotherapy for Major Depressive Disorder

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 a monotherapy for Major Depressive Disorder.

Study identification

NCT ID
NCT05081167
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Relmada Therapeutics, Inc.
Industry
Enrollment
232 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years to 65 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jun 1, 2021
Primary completion
Sep 12, 2022
Completion
Sep 13, 2022
Last update posted
Mar 25, 2024

2021 – 2022

United States locations

U.S. sites
10
U.S. states
4
U.S. cities
9
Facility City State ZIP Site status
Relmada Site Maitland Florida 32751
Relmada Site Miami Florida 33015
Relmada Site Miami Florida 33175
Relmada Site Miami Springs Florida 33166
Relmada Site Orlando Florida 32801
Relmada Site Palm Bay Florida 32905
Relmada Site Chicago Illinois 60634
Relmada Site Boston Massachusetts 02116
Relmada Site Watertown Massachusetts 02472
Relmada Site Austin Texas 78737

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05081167, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Mar 25, 2024 · Synced Sep 2, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT05081167 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →