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

Sponsor

Relmada Therapeutics, Inc. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04688164

Collaborator

(none)

400

Enrollment

Locations

Arms

20.9

Anticipated Duration (Months)

7.5

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Major Depressive Disorder	Drug: REL-1017 Drug: Placebo	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

400 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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)

Actual Study Start Date :

Dec 4, 2020

Anticipated Primary Completion Date :

Sep 1, 2022

Anticipated Study Completion Date :

Sep 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: REL-1017 25 mg 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).	Drug: REL-1017 REL-1017 tablet
Placebo Comparator: Placebo 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).	Drug: Placebo Placebo tablet

Arm

Intervention/Treatment

Experimental: REL-1017 25 mg

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).

Drug: REL-1017

REL-1017 tablet

Placebo Comparator: Placebo

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).

Drug: Placebo

Placebo tablet

Outcome Measures

Primary Outcome Measures

Change in the MADRS10 total score [Day 28]
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 [Day 28]
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 [Day 7]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Relmada Site 116	Phoenix	Arizona	United States	85016
2	Relmada Site 142	Tucson	Arizona	United States	85712
3	Relmada Site 135	Rogers	Arkansas	United States	72758
4	Relmada Site 136	Garden Grove	California	United States	92845
5	Relmada Site 138	Irvine	California	United States	92614
6	Relmada Site 128	Lemon Grove	California	United States	91945
7	Relmada Site 130	Torrance	California	United States	90502
8	Relmada Ste 125	Colorado Springs	Colorado	United States	80910
9	Relmada Site 151	Denver	Colorado	United States	80209
10	Relmada Site 157	Cromwell	Connecticut	United States	06416
11	Relmada Site 140	Fort Myers	Florida	United States	33912
12	Relmada Site 148	Gainesville	Florida	United States	32607
13	Relmada Site 129	Jacksonville	Florida	United States	32256
14	Relmada Site 118	Miami Springs	Florida	United States	33166
15	Relmada Site 100	Miami	Florida	United States	33122
16	Relmada Site 114	Miami	Florida	United States	33175
17	Relmada Site 124	Orlando	Florida	United States	32801
18	Relmada Site 121	Orlando	Florida	United States	32807
19	Relmada Site 110	Palm Bay	Florida	United States	32905
20	Relmada Site 133	Pensacola	Florida	United States	32502
21	Relmada Site 105	Tampa	Florida	United States	33634
22	Relmada Site 113	Decatur	Georgia	United States	30030
23	Relmada Site 101	Chicago	Illinois	United States	60634
24	Relmada Site 107	Chicago	Illinois	United States	60640
25	Relmada Site 158	Boston	Massachusetts	United States	02116
26	Relmada Site 134	New Bedford	Massachusetts	United States	02740
27	Relmada Site 117	Watertown	Massachusetts	United States	02472
28	Relmada Site 147	Flowood	Mississippi	United States	39232
29	Relmada Site 145	O'Fallon	Missouri	United States	63368
30	Relmada Site 122	Marlton	New Jersey	United States	08053
31	Relmada Site 154	Brooklyn	New York	United States	11235
32	Relmada Site 146	Mount Kisco	New York	United States	10549
33	Relmada Site 126	New York	New York	United States	10128
34	Relmada Site 139	Charlotte	North Carolina	United States	28211
35	Relmada Site 109	Beachwood	Ohio	United States	44122
36	Relmada Site 132	Canton	Ohio	United States	44720
37	Relmada Site 144	Cincinnati	Ohio	United States	45215
38	Relmada Site 150	Columbus	Ohio	United States	43210
39	Relmada Site 143	Dayton	Ohio	United States	45417
40	Relmada Site 123	Oklahoma City	Oklahoma	United States	73106
41	Relmada Site 112	Oklahoma City	Oklahoma	United States	73112
42	Relmada Site 106	Oklahoma City	Oklahoma	United States	73118
43	Relmada Site 104	Portland	Oregon	United States	97210
44	Relmada Site 137	Plymouth Meeting	Pennsylvania	United States	19462
45	Relmada Site 119	Memphis	Tennessee	United States	38119
46	Relmada Site 115	Austin	Texas	United States	78737
47	Relmada Site 153	Austin	Texas	United States	78759
48	Relmada Site 149	DeSoto	Texas	United States	75115
49	Relmada Site 111	Houston	Texas	United States	77081
50	Relmada Site 103	Wichita Falls	Texas	United States	76309
51	Relmada Site 102	Woodstock	Vermont	United States	05091
52	Relmada Site 156	Charlottesville	Virginia	United States	22903
53	Relmada Site 108	Everett	Washington	United States	98201

Sponsors and Collaborators

Relmada Therapeutics, Inc.

Investigators

Study Director: Marco Pappagallo, MD, Relmada Therapeutics

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Related Info

Publications

None provided.

Responsible Party:

Relmada Therapeutics, Inc.

ClinicalTrials.gov Identifier:

NCT04688164

Other Study ID Numbers:

REL-1017-301

First Posted:

Dec 29, 2020

Last Update Posted:

Apr 18, 2022

Last Verified:

Apr 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Relmada Therapeutics, Inc.

REL-1017

Additional relevant MeSH terms:

Depressive Disorder

Depression

Depressive Disorder, Major

Study Results

No Results Posted as of Apr 18, 2022