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

Primary Purpose

Major Depressive Disorder

Status
Completed
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

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.

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 Site 116
  • Relmada Site 135
  • Relmada Site 311
  • Relmada Site 209
  • Relmada Site 138
  • Relmada Site 128
  • Relmada Site 300
  • Relmada Site 201
  • Relmada Site 309
  • Relmada Site 312
  • Relmada Site 306
  • Relmada Site 302
  • Relmada Site 151
  • Relmada Site 148
  • Relmada Site 213
  • Relmada Site 129
  • Relmada Site 219
  • Relmada Site 226
  • Relmada Site 206
  • Relmada Site 310
  • Relmada Site 118
  • Relmada Site 218
  • Relmada Site 114
  • Relmada Site 124
  • Relmada Site 110
  • Relmada Site 105
  • Relmada Site 208
  • Relmada Site 301
  • Relmada Site 113
  • Relmada Site 207
  • Relmada Site 222
  • Relmada Site 101
  • Relmada Site 107
  • Relmada Site 304
  • Relmada Site 224
  • Relmada Site 221
  • Relmada Site 158
  • Relmada Site 313
  • Relmada Site 117
  • Relmada Site 305
  • Relmada Site 204
  • Relmada Site 258
  • Relmada Site 126
  • Relmada site 235
  • Relmada Site 143
  • Relmada Site 132
  • Relmada Site 112
  • Relmada Site 307
  • Relmada Site 303
  • Relmada Site 115
  • Relmada Site 153
  • Relmada Site 308
  • Relmada Site 149
  • Relmada Site 214
  • Relmada Site 233
  • Relmada Site 103
  • Relmada Site 102
  • Relmada Site 108

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

During the double blind treatment period (28 days), participants will take 1 tablet of placebo, orally, per day

Outcomes

Primary Outcome Measures

Change in the MADRS10 total score
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.

Secondary Outcome Measures

Change in CGI-S score
Therapeutic efficacy of REL-1017 as an monotherapy 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 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.

Full Information

First Posted
October 4, 2021
Last Updated
November 8, 2022
Sponsor
Relmada Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05081167
Brief Title
A Study to Assess the Efficacy and Safety of REL-1017 as Monotherapy for Major Depressive Disorder (MDD)
Acronym
RELIANCE-III
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
June 2, 2021 (Actual)
Primary Completion Date
August 15, 2022 (Actual)
Study Completion Date
September 30, 2022 (Actual)

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 a monotherapy for Major Depressive Disorder.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
REL-1017

7. Study Design

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

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
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
Intervention Type
Drug
Intervention Name(s)
REL-1017
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 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.
Time Frame
Day 28
Secondary Outcome Measure Information:
Title
Change in CGI-S score
Description
Therapeutic efficacy of REL-1017 as an monotherapy 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 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.
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. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marco Pappagallo, MD
Organizational Affiliation
Relmada Therapeutics
Official's Role
Study Director
Facility Information:
Facility Name
Relmada Site 116
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
Facility Name
Relmada Site 135
City
Rogers
State/Province
Arkansas
ZIP/Postal Code
72758
Country
United States
Facility Name
Relmada Site 311
City
Bellflower
State/Province
California
ZIP/Postal Code
90706
Country
United States
Facility Name
Relmada Site 209
City
Imperial
State/Province
California
ZIP/Postal Code
31405
Country
United States
Facility Name
Relmada Site 138
City
Irvine
State/Province
California
ZIP/Postal Code
92614
Country
United States
Facility Name
Relmada Site 128
City
Lemon Grove
State/Province
California
ZIP/Postal Code
91945
Country
United States
Facility Name
Relmada Site 300
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
Relmada Site 201
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Relmada Site 309
City
Redlands
State/Province
California
ZIP/Postal Code
92374
Country
United States
Facility Name
Relmada Site 312
City
Riverside
State/Province
California
ZIP/Postal Code
92506
Country
United States
Facility Name
Relmada Site 306
City
Santa Ana
State/Province
California
ZIP/Postal Code
92705
Country
United States
Facility Name
Relmada Site 302
City
Upland
State/Province
California
ZIP/Postal Code
91786
Country
United States
Facility Name
Relmada Site 151
City
Denver
State/Province
Colorado
ZIP/Postal Code
80209
Country
United States
Facility Name
Relmada Site 148
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32607
Country
United States
Facility Name
Relmada Site 213
City
Hallandale Beach
State/Province
Florida
ZIP/Postal Code
33009
Country
United States
Facility Name
Relmada Site 129
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
Relmada Site 219
City
Lakeland
State/Province
Florida
ZIP/Postal Code
33803
Country
United States
Facility Name
Relmada Site 226
City
Lauderhill
State/Province
Florida
ZIP/Postal Code
33319
Country
United States
Facility Name
Relmada Site 206
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Facility Name
Relmada Site 310
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Facility Name
Relmada Site 118
City
Miami Springs
State/Province
Florida
ZIP/Postal Code
33166
Country
United States
Facility Name
Relmada Site 218
City
Miami
State/Province
Florida
ZIP/Postal Code
33015
Country
United States
Facility Name
Relmada Site 114
City
Miami
State/Province
Florida
ZIP/Postal Code
33175
Country
United States
Facility Name
Relmada Site 124
City
Orlando
State/Province
Florida
ZIP/Postal Code
32801
Country
United States
Facility Name
Relmada Site 110
City
Palm Bay
State/Province
Florida
ZIP/Postal Code
32905
Country
United States
Facility Name
Relmada Site 105
City
Tampa
State/Province
Florida
ZIP/Postal Code
33634
Country
United States
Facility Name
Relmada Site 208
City
Tampa
State/Province
Florida
ZIP/Postal Code
36614
Country
United States
Facility Name
Relmada Site 301
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30338
Country
United States
Facility Name
Relmada Site 113
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30030
Country
United States
Facility Name
Relmada Site 207
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31405
Country
United States
Facility Name
Relmada Site 222
City
Boise
State/Province
Idaho
ZIP/Postal Code
83704
Country
United States
Facility Name
Relmada Site 101
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60634
Country
United States
Facility Name
Relmada Site 107
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60640
Country
United States
Facility Name
Relmada Site 304
City
Lincolnwood
State/Province
Illinois
ZIP/Postal Code
60712
Country
United States
Facility Name
Relmada Site 224
City
Prairie Village
State/Province
Kansas
ZIP/Postal Code
66208
Country
United States
Facility Name
Relmada Site 221
City
Owensboro
State/Province
Kentucky
ZIP/Postal Code
42303
Country
United States
Facility Name
Relmada Site 158
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02116
Country
United States
Facility Name
Relmada Site 313
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02131
Country
United States
Facility Name
Relmada Site 117
City
Watertown
State/Province
Massachusetts
ZIP/Postal Code
02472
Country
United States
Facility Name
Relmada Site 305
City
Weldon Spring
State/Province
Missouri
ZIP/Postal Code
63304
Country
United States
Facility Name
Relmada Site 204
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89102
Country
United States
Facility Name
Relmada Site 258
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11229
Country
United States
Facility Name
Relmada Site 126
City
New York
State/Province
New York
ZIP/Postal Code
10128
Country
United States
Facility Name
Relmada site 235
City
Staten Island
State/Province
New York
ZIP/Postal Code
10312
Country
United States
Facility Name
Relmada Site 143
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45417
Country
United States
Facility Name
Relmada Site 132
City
North Canton
State/Province
Ohio
ZIP/Postal Code
44720
Country
United States
Facility Name
Relmada Site 112
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Relmada Site 307
City
North Charleston
State/Province
South Carolina
ZIP/Postal Code
29405
Country
United States
Facility Name
Relmada Site 303
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Relmada Site 115
City
Austin
State/Province
Texas
ZIP/Postal Code
78737
Country
United States
Facility Name
Relmada Site 153
City
Austin
State/Province
Texas
ZIP/Postal Code
78759
Country
United States
Facility Name
Relmada Site 308
City
Bellaire
State/Province
Texas
ZIP/Postal Code
77401
Country
United States
Facility Name
Relmada Site 149
City
DeSoto
State/Province
Texas
ZIP/Postal Code
75115
Country
United States
Facility Name
Relmada Site 214
City
Houston
State/Province
Texas
ZIP/Postal Code
77054
Country
United States
Facility Name
Relmada Site 233
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Facility Name
Relmada Site 103
City
Wichita Falls
State/Province
Texas
ZIP/Postal Code
76309
Country
United States
Facility Name
Relmada Site 102
City
Woodstock
State/Province
Vermont
ZIP/Postal Code
05091
Country
United States
Facility Name
Relmada Site 108
City
Everett
State/Province
Washington
ZIP/Postal Code
98201
Country
United States

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 Monotherapy for Major Depressive Disorder (MDD)

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