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

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.
  • 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 Site 116
  • Relmada Site 142
  • Relmada Site 135
  • Relmada Site 136
  • Relmada Site 138
  • Relmada Site 128
  • Relmada Site 130
  • Relmada Ste 125
  • Relmada Site 151
  • Relmada Site 157
  • Relmada Site 140
  • Relmada Site 148
  • Relmada Site 129
  • Relmada Site 118
  • Relmada Site 100
  • Relmada Site 114
  • Relmada Site 124
  • Relmada Site 121
  • Relmada Site 110
  • Relmada Site 133
  • Relmada Site 105
  • Relmada Site 113
  • Relmada Site 101
  • Relmada Site 107
  • Relmada Site 158
  • Relmada Site 134
  • Relmada Site 117
  • Relmada Site 147
  • Relmada Site 145
  • Relmada Site 122
  • Relmada Site 154
  • Relmada Site 146
  • Relmada Site 126
  • Relmada Site 139
  • Relmada Site 109
  • Relmada Site 132
  • Relmada Site 144
  • Relmada Site 150
  • Relmada Site 143
  • Relmada Site 123
  • Relmada Site 112
  • Relmada Site 106
  • Relmada Site 104
  • Relmada Site 137
  • Relmada Site 119
  • Relmada Site 115
  • Relmada Site 153
  • Relmada Site 149
  • Relmada Site 111
  • Relmada Site 103
  • Relmada Site 102
  • Relmada Site 156
  • 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 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 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 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 0 to 60 with scores above 34 indicating severe depression. A negative change from baseline indicates improvement.

Full Information

First Posted
December 7, 2020
Last Updated
November 8, 2022
Sponsor
Relmada Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04688164
Brief Title
A Study to Assess the Efficacy and Safety of REL-1017 as Adjunctive Treatment for Major Depressive Disorder (MDD)
Acronym
RELIANCE-I
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-I Study)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
December 4, 2020 (Actual)
Primary Completion Date
September 29, 2022 (Actual)
Study Completion Date
November 9, 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 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
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 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
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 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 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 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. 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.
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 142
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Relmada Site 135
City
Rogers
State/Province
Arkansas
ZIP/Postal Code
72758
Country
United States
Facility Name
Relmada Site 136
City
Garden Grove
State/Province
California
ZIP/Postal Code
92845
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 130
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
Relmada Ste 125
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80910
Country
United States
Facility Name
Relmada Site 151
City
Denver
State/Province
Colorado
ZIP/Postal Code
80209
Country
United States
Facility Name
Relmada Site 157
City
Cromwell
State/Province
Connecticut
ZIP/Postal Code
06416
Country
United States
Facility Name
Relmada Site 140
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33912
Country
United States
Facility Name
Relmada Site 148
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32607
Country
United States
Facility Name
Relmada Site 129
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
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 100
City
Miami
State/Province
Florida
ZIP/Postal Code
33122
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 121
City
Orlando
State/Province
Florida
ZIP/Postal Code
32807
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 133
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32502
Country
United States
Facility Name
Relmada Site 105
City
Tampa
State/Province
Florida
ZIP/Postal Code
33634
Country
United States
Facility Name
Relmada Site 113
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30030
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 158
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02116
Country
United States
Facility Name
Relmada Site 134
City
New Bedford
State/Province
Massachusetts
ZIP/Postal Code
02740
Country
United States
Facility Name
Relmada Site 117
City
Watertown
State/Province
Massachusetts
ZIP/Postal Code
02472
Country
United States
Facility Name
Relmada Site 147
City
Flowood
State/Province
Mississippi
ZIP/Postal Code
39232
Country
United States
Facility Name
Relmada Site 145
City
O'Fallon
State/Province
Missouri
ZIP/Postal Code
63368
Country
United States
Facility Name
Relmada Site 122
City
Marlton
State/Province
New Jersey
ZIP/Postal Code
08053
Country
United States
Facility Name
Relmada Site 154
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11235
Country
United States
Facility Name
Relmada Site 146
City
Mount Kisco
State/Province
New York
ZIP/Postal Code
10549
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 139
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28211
Country
United States
Facility Name
Relmada Site 109
City
Beachwood
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Facility Name
Relmada Site 132
City
Canton
State/Province
Ohio
ZIP/Postal Code
44720
Country
United States
Facility Name
Relmada Site 144
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45215
Country
United States
Facility Name
Relmada Site 150
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Relmada Site 143
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45417
Country
United States
Facility Name
Relmada Site 123
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73106
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 106
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73118
Country
United States
Facility Name
Relmada Site 104
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Relmada Site 137
City
Plymouth Meeting
State/Province
Pennsylvania
ZIP/Postal Code
19462
Country
United States
Facility Name
Relmada Site 119
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 149
City
DeSoto
State/Province
Texas
ZIP/Postal Code
75115
Country
United States
Facility Name
Relmada Site 111
City
Houston
State/Province
Texas
ZIP/Postal Code
77081
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 156
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
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

Learn more about this trial

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

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