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RELIANCE-II: 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
NCT04855747
Collaborator
(none)
400
Enrollment
46
Locations
2
Arms
20.1
Anticipated Duration (Months)
8.7
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
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-II Study)
Actual Study Start Date :
Mar 30, 2021
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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.

  2. 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:
No
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 259 Saraland Alabama United States 36571
2 Relmada Site 203 Little Rock Arkansas United States 72211
3 Relmada Site 225 Encino California United States 91316
4 Relmada Site 200 Glendale California United States 91206
5 Relmada Site 209 Imperial California United States 92251
6 Relmada Site 249 La Habra California United States 90631
7 Relmada Site 261 La Jolla California United States 92037
8 Relmada Site 201 Orange California United States 92868
9 Relmada Site 251 San Diego California United States 92103
10 Relmada Site 220 Santa Ana California United States 92704
11 Relmada Site 211 Norwich Connecticut United States 06360
12 Relmada Site 213 Hallandale Beach Florida United States 33009
13 Relmada Site 234 Lake City Florida United States 32055
14 Relmada Site 219 Lakeland Florida United States 33803
15 Relmada Site 226 Lauderhill Florida United States 33319
16 Relmada Site 206 Maitland Florida United States 32751
17 Relmada Site 218 Miami Florida United States 33015
18 Relmada Site 229 Miami Florida United States 33125
19 Relmada Site 232 Orange City Florida United States 32763
20 Relmada Site 208 Tampa Florida United States 33614
21 Relmada Site 260 West Palm Beach Florida United States 33407
22 Relmada Site 254 Grayson Georgia United States 30017
23 Relmada Site 207 Savannah Georgia United States 31405
24 Relmada Site 222 Boise Idaho United States 83704
25 Relmada Site 224 Prairie Village Kansas United States 66208
26 Relmada Site 250 Shawnee Mission Kansas United States 66218
27 Relmada Site 221 Owensboro Kentucky United States 42303
28 Relmada Site 247 Gaithersburg Maryland United States 20877
29 Relmada Site 257 Towson Maryland United States 21204
30 Relmada Site 253 Roslindale Massachusetts United States 02131
31 Relmada Site 204 Las Vegas Nevada United States 89102
32 Relmada Site 238 Princeton New Jersey United States 08540
33 Relmada Site 262 New York New York United States 10032
34 Relmada Site 235 Staten Island New York United States 10312
35 Relmada Site 227 Fayetteville North Carolina United States 28303
36 Relmada Site 244 Shelby North Carolina United States 28150
37 Relmada Site 240 Cincinnati Ohio United States 45219
38 Relmada Site 246 Middleburg Heights Ohio United States 44130
39 Relmada Site 212 Oklahoma City Oklahoma United States 73112
40 Relmada Site 236 Allentown Pennsylvania United States 18104
41 Relmada Site 241 Baytown Texas United States 77521
42 Relmada site 256 Dallas Texas United States 75243
43 Relmada Site 214 Houston Texas United States 77054
44 Relmada Site 233 Plano Texas United States 75093
45 Relmada Site 252 Red Oak Texas United States 75154
46 Relmada Site 242 Waukesha Wisconsin United States 53188

Sponsors and Collaborators

  • Relmada Therapeutics, Inc.

Investigators

  • Study Director: Marco Pappagallo, MD, Relmada Therapeutics

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Relmada Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT04855747
Other Study ID Numbers:
  • REL-1017-302
First Posted:
Apr 22, 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:
No
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