search
Back to results

Randomized, Double-Blind, Placebo-Controlled Trial of REL-1017 as Adjunctive Treatment for MDD (RELIGHT)

Primary Purpose

Major Depressive Disorder, Depression

Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
REL-1017
Placebo
Sponsored by
Relmada Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring REL-1017, esmethadone, Relmada, antidepressant, adjunctive, NMDA receptor antagonist, Relight, Depression

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Male or female outpatients, 18-65 years of age, inclusive. Currently meets DSM-5 criteria for MDD without psychotic features, based on the SCID-5-CT, with a current major depressive episode (MDE). Inadequate response to 1 to 3 adequate antidepressant treatments in the current MDE. Exclusion Criteria: Psychiatric hospitalization during the current major depressive episode. History or presence of clinically significant health conditions which in the opinion of the Investigator would negatively impact the safety of the participant. Participants who, in the Investigator's judgment, are at significant risk for suicide. Pregnant or planning to become pregnant. Breast-feeding or planning to breast-feed.

Sites / Locations

  • Relmada SiteRecruiting
  • Relmada SiteRecruiting
  • Relmada SiteRecruiting
  • Relmada SiteRecruiting
  • Relmada SiteRecruiting
  • Relmada SiteRecruiting
  • Relmada SiteRecruiting
  • Relmada SiteRecruiting
  • Relmada SiteRecruiting
  • Relmada SiteRecruiting
  • Relmada SiteRecruiting
  • Relmada SiteRecruiting
  • Relmada SiteRecruiting
  • Relmada SiteRecruiting
  • Relmada SiteRecruiting
  • Relmada SiteRecruiting
  • Relmada SiteRecruiting
  • Relmada SiteRecruiting
  • Relmada SiteRecruiting
  • Relmada SiteRecruiting
  • Relmada SiteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

REL-1017 25 mg

Placebo

Arm Description

During the double blind treatment period (28 days), participants will take 1 tablet of REL-1017 25 mg, orally, per day in addition to their ongoing antidepressant (ADT)

During the double blind treatment period (28 days), participants will take 1 tablet of placebo, orally, per day in addition to their ongoing antidepressant (ADT)

Outcomes

Primary Outcome Measures

Change in MADRS Total Score From Baseline to Day 28
The MADRS is a 10-item scale and items are scored between 0-6 points. For each item, a score of 0 indicates the absence of symptoms, and a score of 6 indicates symptoms of maximum severity. A maximum total score is 60 points.

Secondary Outcome Measures

Full Information

First Posted
August 21, 2023
Last Updated
September 27, 2023
Sponsor
Relmada Therapeutics, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT06011577
Brief Title
Randomized, Double-Blind, Placebo-Controlled Trial of REL-1017 as Adjunctive Treatment for MDD
Acronym
RELIGHT
Official Title
A Randomized, Double-Blind, Placebo-Controlled Trial of REL-1017 as an Adjunctive Treatment for Major Depressive Disorder (RELIGHT)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 17, 2023 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Relmada Therapeutics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
A Phase 3, randomized, double-blind, placebo-controlled, multicenter trial of REL-1017 in patients with major depressive disorder (MDD).
Detailed Description
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 in patients with inadequate response to ongoing background antidepressant treatment. Eligible patients will continue to take their background antidepressant therapy and be randomized in a 1:1 ratio to treatment with REL-1017 or placebo for a 4 week treatment period.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder, Depression
Keywords
REL-1017, esmethadone, Relmada, antidepressant, adjunctive, NMDA receptor antagonist, Relight, Depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
REL-1017 25 mg
Arm Type
Experimental
Arm Description
During the double blind treatment period (28 days), participants will take 1 tablet of REL-1017 25 mg, orally, per day in addition to their ongoing antidepressant (ADT)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
During the double blind treatment period (28 days), participants will take 1 tablet of placebo, orally, per day in addition to their ongoing antidepressant (ADT)
Intervention Type
Drug
Intervention Name(s)
REL-1017
Other Intervention Name(s)
esmethadone
Intervention Description
REL-1017 tablet
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo tablet
Primary Outcome Measure Information:
Title
Change in MADRS Total Score From Baseline to Day 28
Description
The MADRS is a 10-item scale and items are scored between 0-6 points. For each item, a score of 0 indicates the absence of symptoms, and a score of 6 indicates symptoms of maximum severity. A maximum total score is 60 points.
Time Frame
Day 28

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female outpatients, 18-65 years of age, inclusive. Currently meets DSM-5 criteria for MDD without psychotic features, based on the SCID-5-CT, with a current major depressive episode (MDE). Inadequate response to 1 to 3 adequate antidepressant treatments in the current MDE. Exclusion Criteria: Psychiatric hospitalization during the current major depressive episode. History or presence of clinically significant health conditions which in the opinion of the Investigator would negatively impact the safety of the participant. Participants who, in the Investigator's judgment, are at significant risk for suicide. Pregnant or planning to become pregnant. Breast-feeding or planning to breast-feed.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Medical Director
Phone
786-638-7384
Email
clinicaltrials@relmada.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cedric O'Gorman, MD
Organizational Affiliation
Relmada Therapeutics
Official's Role
Study Director
Facility Information:
Facility Name
Relmada Site
City
Culver City
State/Province
California
ZIP/Postal Code
90230
Country
United States
Individual Site Status
Recruiting
Facility Name
Relmada Site
City
Lafayette
State/Province
California
ZIP/Postal Code
94549
Country
United States
Individual Site Status
Recruiting
Facility Name
Relmada Site
City
Newport Beach
State/Province
California
ZIP/Postal Code
92660
Country
United States
Individual Site Status
Recruiting
Facility Name
Relmada Site
City
Sherman Oaks
State/Province
California
ZIP/Postal Code
91403
Country
United States
Individual Site Status
Recruiting
Facility Name
Relmada Site
City
Brandon
State/Province
Florida
ZIP/Postal Code
33511
Country
United States
Individual Site Status
Recruiting
Facility Name
Relmada Site
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Individual Site Status
Recruiting
Facility Name
Relmada Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33133
Country
United States
Individual Site Status
Recruiting
Facility Name
Relmada Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33174
Country
United States
Individual Site Status
Recruiting
Facility Name
Relmada Site
City
Okeechobee
State/Province
Florida
ZIP/Postal Code
34972
Country
United States
Individual Site Status
Recruiting
Facility Name
Relmada Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607
Country
United States
Individual Site Status
Recruiting
Facility Name
Relmada Site
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21208
Country
United States
Individual Site Status
Recruiting
Facility Name
Relmada Site
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
33024
Country
United States
Individual Site Status
Recruiting
Facility Name
Relmada Site
City
Toms River
State/Province
New Jersey
ZIP/Postal Code
08755
Country
United States
Individual Site Status
Recruiting
Facility Name
Relmada Site
City
Cedarhurst
State/Province
New York
ZIP/Postal Code
11516
Country
United States
Individual Site Status
Recruiting
Facility Name
Relmada Site
City
New York
State/Province
New York
ZIP/Postal Code
10036
Country
United States
Individual Site Status
Recruiting
Facility Name
Relmada Site
City
Franklin
State/Province
Tennessee
ZIP/Postal Code
37067
Country
United States
Individual Site Status
Recruiting
Facility Name
Relmada Site
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Individual Site Status
Recruiting
Facility Name
Relmada Site
City
Bellaire
State/Province
Texas
ZIP/Postal Code
77401
Country
United States
Individual Site Status
Recruiting
Facility Name
Relmada Site
City
Friendswood
State/Province
Texas
ZIP/Postal Code
77546
Country
United States
Individual Site Status
Recruiting
Facility Name
Relmada Site
City
Wichita Falls
State/Province
Texas
ZIP/Postal Code
76309
Country
United States
Individual Site Status
Recruiting
Facility Name
Relmada Site
City
Draper
State/Province
Utah
ZIP/Postal Code
84020
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Links:
URL
http://www.relightstudies.com
Description
Study Homepage

Learn more about this trial

Randomized, Double-Blind, Placebo-Controlled Trial of REL-1017 as Adjunctive Treatment for MDD

We'll reach out to this number within 24 hrs