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

Sponsor

Relmada Therapeutics, Inc. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05081167

Collaborator

(none)

400

Enrollment

Locations

Arms

Anticipated Duration (Months)

6.9

Patients Per Site

0.6

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 a monotherapy for Major Depressive Disorder.

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 Monotherapy for Major Depressive Disorder

Actual Study Start Date :

Jun 2, 2021

Anticipated Primary Completion Date :

Jun 1, 2022

Anticipated Study Completion Date :

Jun 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	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	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

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

Drug: Placebo

Placebo tablet

Outcome Measures

Primary Outcome Measures

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

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.

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 135	Rogers	Arkansas	United States	72758
3	Relmada Site 311	Bellflower	California	United States	90706
4	Relmada Site 209	Imperial	California	United States	31405
5	Relmada Site 138	Irvine	California	United States	92614
6	Relmada Site 128	Lemon Grove	California	United States	91945
7	Relmada Site 300	Oceanside	California	United States	92056
8	Relmada Site 201	Orange	California	United States	92868
9	Relmada Site 309	Redlands	California	United States	92374
10	Relmada Site 312	Riverside	California	United States	92506
11	Relmada Site 306	Santa Ana	California	United States	92705
12	Relmada Site 302	Upland	California	United States	91786
13	Relmada Site 151	Denver	Colorado	United States	80209
14	Relmada Site 148	Gainesville	Florida	United States	32607
15	Relmada Site 213	Hallandale Beach	Florida	United States	33009
16	Relmada Site 129	Jacksonville	Florida	United States	32256
17	Relmada Site 219	Lakeland	Florida	United States	33803
18	Relmada Site 226	Lauderhill	Florida	United States	33319
19	Relmada Site 206	Maitland	Florida	United States	32751
20	Relmada Site 310	Maitland	Florida	United States	32751
21	Relmada Site 118	Miami Springs	Florida	United States	33166
22	Relmada Site 218	Miami	Florida	United States	33015
23	Relmada Site 114	Miami	Florida	United States	33175
24	Relmada Site 124	Orlando	Florida	United States	32801
25	Relmada Site 110	Palm Bay	Florida	United States	32905
26	Relmada Site 105	Tampa	Florida	United States	33634
27	Relmada Site 208	Tampa	Florida	United States	36614
28	Relmada Site 301	Atlanta	Georgia	United States	30338
29	Relmada Site 113	Decatur	Georgia	United States	30030
30	Relmada Site 207	Savannah	Georgia	United States	31405
31	Relmada Site 222	Boise	Idaho	United States	83704
32	Relmada Site 101	Chicago	Illinois	United States	60634
33	Relmada Site 107	Chicago	Illinois	United States	60640
34	Relmada Site 304	Lincolnwood	Illinois	United States	60712
35	Relmada Site 224	Prairie Village	Kansas	United States	66208
36	Relmada Site 221	Owensboro	Kentucky	United States	42303
37	Relmada Site 158	Boston	Massachusetts	United States	02116
38	Relmada Site 313	Boston	Massachusetts	United States	02131
39	Relmada Site 117	Watertown	Massachusetts	United States	02472
40	Relmada Site 305	Weldon Spring	Missouri	United States	63304
41	Relmada Site 204	Las Vegas	Nevada	United States	89102
42	Relmada Site 258	Brooklyn	New York	United States	11229
43	Relmada Site 126	New York	New York	United States	10128
44	Relmada site 235	Staten Island	New York	United States	10312
45	Relmada Site 143	Dayton	Ohio	United States	45417
46	Relmada Site 132	North Canton	Ohio	United States	44720
47	Relmada Site 112	Oklahoma City	Oklahoma	United States	73112
48	Relmada Site 307	North Charleston	South Carolina	United States	29405
49	Relmada Site 303	Memphis	Tennessee	United States	38119
50	Relmada Site 115	Austin	Texas	United States	78737
51	Relmada Site 153	Austin	Texas	United States	78759
52	Relmada Site 308	Bellaire	Texas	United States	77401
53	Relmada Site 149	DeSoto	Texas	United States	75115
54	Relmada Site 214	Houston	Texas	United States	77054
55	Relmada Site 233	Plano	Texas	United States	75093
56	Relmada Site 103	Wichita Falls	Texas	United States	76309
57	Relmada Site 102	Woodstock	Vermont	United States	05091
58	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:

NCT05081167

Other Study ID Numbers:

REL-1017-303

First Posted:

Oct 18, 2021

Last Update Posted:

May 10, 2022

Last Verified:

May 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 May 10, 2022