NCT05081167

Brief 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 a monotherapy for Major Depressive Disorder.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
232

participants targeted

Target at P25-P50 for phase_3 major-depressive-disorder

Timeline
Completed

Started Jun 2021

Geographic Reach
1 country

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 2, 2021

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 4, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

October 18, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 13, 2022

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 14, 2022

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

March 26, 2024

Completed
Last Updated

March 26, 2024

Status Verified

March 1, 2024

Enrollment Period

1.3 years

First QC Date

October 4, 2021

Results QC Date

February 16, 2024

Last Update Submit

March 25, 2024

Conditions

Major Depressive Disorder

Keywords

REL-1017

Outcome Measures

Primary Outcomes (1)

  • Change in the MADRS10 Total Score From Baseline to Day 28

    Therapeutic efficacy of REL-1017 as monotherapy 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.

    Day 28

Secondary Outcomes (2)

  • MADRS10 Remission Rate (Total Score ≤10) at Day 28

    Day 28

  • MADRS10 Response Rate (Improvement ≥50% Compared With Total Baseline Score) at Day 28

    Day 28

Study Arms (2)

REL-1017

EXPERIMENTAL

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.

Drug: REL-1017

Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

REL-1017DRUG

REL-1017 tablet

Also known as: esmethadone
REL-1017
PlaceboDRUG

Placebo tablet

Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults 18 to 65 years, inclusive.
  • 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.

You may not qualify if:

  • Any current and primary psychiatric disorder other than Major Depressive Disorder.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Relmada Site

Maitland, Florida, 32751, United States

Location

Relmada Site

Miami, Florida, 33015, United States

Location

Relmada Site

Miami, Florida, 33175, United States

Location

Relmada Site

Miami Springs, Florida, 33166, United States

Location

Relmada Site

Orlando, Florida, 32801, United States

Location

Relmada Site

Palm Bay, Florida, 32905, United States

Location

Relmada Site

Chicago, Illinois, 60634, United States

Location

Relmada Site

Boston, Massachusetts, 02116, United States

Location

Relmada Site

Watertown, Massachusetts, 02472, United States

Location

Relmada Site

Austin, Texas, 78737, United States

Location

Related Links

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Results Point of Contact

Title
Marco Pappagallo, MD
Organization
Relmada Therapeutics
info@relmada.com
786-638-7384

Study Officials

  • Marco Pappagallo, MD

    Relmada Therapeutics

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR
Expanded Access
Yes

Study Record Dates

First Submitted

October 4, 2021

First Posted

October 18, 2021

Study Start

June 2, 2021

Primary Completion

September 13, 2022

Study Completion

September 14, 2022

Last Updated

March 26, 2024

Results First Posted

March 26, 2024

Record last verified: 2024-03

Locations

US(10)