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

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, Relmada, NMDA receptor antagonist, esmethadone, adjunctive, antidepressant, Reliance, Depression

Eligibility Criteria

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

Inclusion Criteria:

  • Adults 18 to 65 years, inclusive.
  • Diagnosed with Major Depressive Disorder (MDD) based on Structured Clinical Interview for DSM-5 (SCID-5) for MDD.
  • Current major depressive episode.
  • Treated on approved, stable first-line anti-depressant therapy with inadequate response to 1 to 3 valid courses of treatment with an antidepressant medication

Exclusion Criteria:

  • 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.

Sites / Locations

  • Relmada SiteRecruiting
  • Relmada SiteRecruiting
  • Relmada SiteRecruiting
  • Relmada SiteRecruiting
  • Relmada SiteRecruiting
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  • 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 the MADRS10 total score
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 Oto 60 with scores above 34 indicating severe depression. A negative change from baseline indicates improvement.

Secondary Outcome Measures

Change in CGI-S score
Therapeutic efficacy of REL-1017 as an adjunctive treatment versus placebo in Clinical Global Impression of Severity (CGI-S) The CGI-S is a standard method used in clinical studies to quantify and track patient progress and treatment response over time. The scale is composed of 7 ratings: 1 = normal, not at all ill; 2 = borderline ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill patients. The score ranges from 1 to 7, and a lower CGI-S score indicates lower levels of depression.
Change in the MADRS10 total score
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 Oto 60 with scores above 34 indicating severe depression. A negative change from baseline indicates improvement.

Full Information

First Posted
April 19, 2021
Last Updated
August 14, 2023
Sponsor
Relmada Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04855747
Brief Title
A Study to Assess the Efficacy and Safety of REL-1017 as Adjunctive Treatment for Major Depressive Disorder (MDD)
Acronym
RELIANCE-II
Official Title
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo- Controlled Study to Assess the Efficacy and Safety of REL-1017 as Adjunctive Treatment of Major Depressive Disorder (The RELIANCE-II Study)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 30, 2021 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 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
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.

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, Relmada, NMDA receptor antagonist, esmethadone, adjunctive, antidepressant, Reliance, Depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
400 (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 the MADRS10 total score
Description
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 Oto 60 with scores above 34 indicating severe depression. A negative change from baseline indicates improvement.
Time Frame
Day 28
Secondary Outcome Measure Information:
Title
Change in CGI-S score
Description
Therapeutic efficacy of REL-1017 as an adjunctive treatment versus placebo in Clinical Global Impression of Severity (CGI-S) The CGI-S is a standard method used in clinical studies to quantify and track patient progress and treatment response over time. The scale is composed of 7 ratings: 1 = normal, not at all ill; 2 = borderline ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill patients. The score ranges from 1 to 7, and a lower CGI-S score indicates lower levels of depression.
Time Frame
Day 28
Title
Change in the MADRS10 total score
Description
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 Oto 60 with scores above 34 indicating severe depression. A negative change from baseline indicates improvement.
Time Frame
Day 7

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: Adults 18 to 65 years, inclusive. Diagnosed with Major Depressive Disorder (MDD) based on Structured Clinical Interview for DSM-5 (SCID-5) for MDD. Current major depressive episode. Treated on approved, stable first-line anti-depressant therapy with inadequate response to 1 to 3 valid courses of treatment with an antidepressant medication Exclusion Criteria: 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. Any lifetime experience of having received ketamine or esketamine as a treatment for MDD, or as part of a clinical trial.
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
Saraland
State/Province
Alabama
ZIP/Postal Code
36571
Country
United States
Individual Site Status
Recruiting
Facility Name
Relmada Site
City
Encino
State/Province
California
ZIP/Postal Code
91316
Country
United States
Individual Site Status
Recruiting
Facility Name
Relmada Site
City
Glendale
State/Province
California
ZIP/Postal Code
91206
Country
United States
Individual Site Status
Recruiting
Facility Name
Relmada Site
City
Imperial
State/Province
California
ZIP/Postal Code
92251
Country
United States
Individual Site Status
Recruiting
Facility Name
Relmada Site
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Individual Site Status
Recruiting
Facility Name
Relmada Site
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Individual Site Status
Recruiting
Facility Name
Relmada Site
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Individual Site Status
Recruiting
Facility Name
Relmada Site
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Individual Site Status
Recruiting
Facility Name
Relmada Site
City
Norwich
State/Province
Connecticut
ZIP/Postal Code
06360
Country
United States
Individual Site Status
Recruiting
Facility Name
Relmada Site
City
Hallandale Beach
State/Province
Florida
ZIP/Postal Code
33009
Country
United States
Individual Site Status
Recruiting
Facility Name
Relmada Site
City
Lake City
State/Province
Florida
ZIP/Postal Code
32055
Country
United States
Individual Site Status
Recruiting
Facility Name
Relmada Site
City
Lakeland
State/Province
Florida
ZIP/Postal Code
33803
Country
United States
Individual Site Status
Recruiting
Facility Name
Relmada Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33125
Country
United States
Individual Site Status
Recruiting
Facility Name
Relmada Site
City
Orange City
State/Province
Florida
ZIP/Postal Code
32763
Country
United States
Individual Site Status
Recruiting
Facility Name
Relmada Site
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32792
Country
United States
Individual Site Status
Recruiting
Facility Name
Relmada Site
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31405
Country
United States
Individual Site Status
Recruiting
Facility Name
Relmada Site
City
Boise
State/Province
Idaho
ZIP/Postal Code
83704
Country
United States
Individual Site Status
Recruiting
Facility Name
Relmada Site
City
Gaithersburg
State/Province
Maryland
ZIP/Postal Code
20877
Country
United States
Individual Site Status
Recruiting
Facility Name
Relmada Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89102
Country
United States
Individual Site Status
Recruiting
Facility Name
Relmada Site
City
Princeton
State/Province
New Jersey
ZIP/Postal Code
08540
Country
United States
Individual Site Status
Recruiting
Facility Name
Relmada Site
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Recruiting
Facility Name
Relmada Site
City
Staten Island
State/Province
New York
ZIP/Postal Code
10312
Country
United States
Individual Site Status
Recruiting
Facility Name
Relmada Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Individual Site Status
Recruiting
Facility Name
Relmada Site
City
Middleburg Heights
State/Province
Ohio
ZIP/Postal Code
44130
Country
United States
Individual Site Status
Recruiting
Facility Name
Relmada Site
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18104
Country
United States
Individual Site Status
Recruiting
Facility Name
Relmada Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75243
Country
United States
Individual Site Status
Recruiting
Facility Name
Relmada Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77054
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Links:
URL
http://reliancestudies.com
Description
Related Info

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

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