RELIANCE-OLS: Safety of REL-1017 for Major Depressive Disorder
Sponsor
Relmada Therapeutics, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04855760
Collaborator
(none)
600
103
1
27
5.8
0.2
Study Details
Study Description
Brief Summary
This is a 1-year open-label study to access the 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 for the duration of the treatment period.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
600 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 3, Multicenter, Open-Label Study to Assess the Long-Term Safety of REL-1017 as Adjunctive Treatment of Major Depressive Disorder
Actual Study Start Date
:
Apr 1, 2021
Anticipated Primary Completion Date
:
Jul 1, 2023
Anticipated Study Completion Date
:
Jul 1, 2023
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: REL-1017 25 mg 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
|
Outcome Measures
Primary Outcome Measures
- Safety and tolerability of REL-1017 as incidence of treatment emergent adverse events (TEAEs) [52 weeks]
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.
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 116 | Phoenix | Arizona | United States | 85016 |
| 3 | Relmada Site 142 | Tucson | Arizona | United States | 85712 |
| 4 | Relmada Site 203 | Little Rock | Arkansas | United States | 72211 |
| 5 | Relmada Site 248 | Little Rock | Arkansas | United States | 72211 |
| 6 | Relmada Site 135 | Rogers | Arkansas | United States | 72758 |
| 7 | Relmada Site 311 | Bellflower | California | United States | 90706 |
| 8 | Relmada Site 225 | Encino | California | United States | 91316 |
| 9 | Relmada Site 136 | Garden Grove | California | United States | 92845 |
| 10 | Relmada Site 200 | Glendale | California | United States | 91206 |
| 11 | Relmada Site 209 | Imperial | California | United States | 92251 |
| 12 | Relmada Site 138 | Irvine | California | United States | 92614 |
| 13 | Relmada Site 261 | La Jolla | California | United States | 92037 |
| 14 | Relmada Site 128 | Lemon Grove | California | United States | 91945 |
| 15 | Relmada Site 300 | Oceanside | California | United States | 92056 |
| 16 | Relmada Site 201 | Orange | California | United States | 92868 |
| 17 | Relmada Site 309 | Redlands | California | United States | 92374 |
| 18 | Relmada Site 312 | Riverside | California | United States | 92506 |
| 19 | Relmada Site 220 | Santa Ana | California | United States | 92704 |
| 20 | Relmada Site 306 | Santa Ana | California | United States | 92705 |
| 21 | Relmada Site 130 | Torrance | California | United States | 90502 |
| 22 | Relmada Site 302 | Upland | California | United States | 91786 |
| 23 | Relmada Site 125 | Colorado Springs | Colorado | United States | 80910 |
| 24 | Relmada Site 151 | Denver | Colorado | United States | 80209 |
| 25 | Relmada Site 157 | Cromwell | Connecticut | United States | 06416 |
| 26 | Relmada Site 211 | Norwich | Connecticut | United States | 06360 |
| 27 | Relmada Site 140 | Fort Myers | Florida | United States | 33912 |
| 28 | Relmada Site 148 | Gainesville | Florida | United States | 32607 |
| 29 | Relmada Site 213 | Hallandale Beach | Florida | United States | 33009 |
| 30 | Relmada Site 129 | Jacksonville | Florida | United States | 32256 |
| 31 | Relmada Site 234 | Lake City | Florida | United States | 32055 |
| 32 | Relmada Site 219 | Lakeland | Florida | United States | 33803 |
| 33 | Relmada Site 226 | Lauderhill | Florida | United States | 33319 |
| 34 | Relmada Site 206 | Maitland | Florida | United States | 32751 |
| 35 | Relmada Site 310 | Maitland | Florida | United States | 32751 |
| 36 | Relmada Site 118 | Miami Springs | Florida | United States | 33166 |
| 37 | Relmada Site 218 | Miami | Florida | United States | 33015 |
| 38 | Relmada Site 100 | Miami | Florida | United States | 33122 |
| 39 | Relmada Site 229 | Miami | Florida | United States | 33125 |
| 40 | Relmada Site 114 | Miami | Florida | United States | 33175 |
| 41 | Relmada Site 124 | Orlando | Florida | United States | 32801 |
| 42 | Relmada Site 121 | Orlando | Florida | United States | 32807 |
| 43 | Relmada Site 110 | Palm Bay | Florida | United States | 32905 |
| 44 | Relmada Site 133 | Pensacola | Florida | United States | 32502 |
| 45 | Relmada Site 208 | Tampa | Florida | United States | 33614 |
| 46 | Relmada Site 105 | Tampa | Florida | United States | 33634 |
| 47 | Relmada Site 260 | West Palm Beach | Florida | United States | 33407 |
| 48 | Relmada Site 301 | Atlanta | Georgia | United States | 30338 |
| 49 | Relmada Site 113 | Decatur | Georgia | United States | 30030 |
| 50 | Relmada Site 254 | Grayson | Georgia | United States | 30017 |
| 51 | Relmada Site 207 | Savannah | Georgia | United States | 31405 |
| 52 | Relmada Site 222 | Boise | Idaho | United States | 83704 |
| 53 | Relmada Site 101 | Chicago | Illinois | United States | 60634 |
| 54 | Relmada Site 107 | Chicago | Illinois | United States | 60640 |
| 55 | Relmada Site 224 | Prairie Village | Kansas | United States | 66208 |
| 56 | Relmada Site 250 | Shawnee Mission | Kansas | United States | 66218 |
| 57 | Relmada Site 221 | Owensboro | Kentucky | United States | 42303 |
| 58 | Relmada Site 247 | Gaithersburg | Maryland | United States | 20877 |
| 59 | Relmada Site 158 | Boston | Massachusetts | United States | 02116 |
| 60 | Relmada Site 134 | New Bedford | Massachusetts | United States | 02740 |
| 61 | Relmada Site 253 | Roslindale | Massachusetts | United States | 02131 |
| 62 | Relmada Site 117 | Watertown | Massachusetts | United States | 02472 |
| 63 | Relmada Site 147 | Flowood | Mississippi | United States | 39232 |
| 64 | Relmada Site 145 | O'Fallon | Missouri | United States | 63368 |
| 65 | Relmada Site 305 | Weldon Spring | Missouri | United States | 63304 |
| 66 | Relmada Site 204 | Las Vegas | Nevada | United States | 89102 |
| 67 | Relmada Site 122 | Marlton | New Jersey | United States | 08053 |
| 68 | Relmada Site 238 | Princeton | New Jersey | United States | 08540 |
| 69 | Relmada Site 258 | Brooklyn | New York | United States | 11229 |
| 70 | Relmada Site 146 | Mount Kisco | New York | United States | 10549 |
| 71 | Relmada Site 126 | New York | New York | United States | 10128 |
| 72 | Relmada Site 235 | Staten Island | New York | United States | 10312 |
| 73 | Relmada Site 139 | Charlotte | North Carolina | United States | 28211 |
| 74 | Relmada Site 109 | Beachwood | Ohio | United States | 44122 |
| 75 | Relmada Site 144 | Cincinnati | Ohio | United States | 45215 |
| 76 | Relmada Site 150 | Columbus | Ohio | United States | 43210 |
| 77 | Relmada Site 143 | Dayton | Ohio | United States | 45417 |
| 78 | Relmada Site 246 | Middleburg Heights | Ohio | United States | 44130 |
| 79 | Relmada Site 132 | North Canton | Ohio | United States | 44720 |
| 80 | Relmada Site 123 | Oklahoma City | Oklahoma | United States | 73106 |
| 81 | Relmada Site 112 | Oklahoma City | Oklahoma | United States | 73112 |
| 82 | Relmada Site 212 | Oklahoma City | Oklahoma | United States | 73112 |
| 83 | Relmada Site 106 | Oklahoma City | Oklahoma | United States | 73118 |
| 84 | Relmada Site 104 | Portland | Oregon | United States | 97210 |
| 85 | Relmada Site 236 | Allentown | Pennsylvania | United States | 18104 |
| 86 | Relmada Site 137 | Plymouth Meeting | Pennsylvania | United States | 19462 |
| 87 | Relmada Site 307 | North Charleston | South Carolina | United States | 29405 |
| 88 | Relmada Site 119 | Memphis | Tennessee | United States | 38119 |
| 89 | Relmada Site 303 | Memphis | Tennessee | United States | 38119 |
| 90 | Relmada Site 115 | Austin | Texas | United States | 78737 |
| 91 | Relmada Site 153 | Austin | Texas | United States | 78759 |
| 92 | Relmada Site 241 | Baytown | Texas | United States | 77521 |
| 93 | Relmada Site 308 | Bellaire | Texas | United States | 77401 |
| 94 | Relmada Site 256 | Dallas | Texas | United States | 75243 |
| 95 | Relmada Site 149 | DeSoto | Texas | United States | 75115 |
| 96 | Relmada Site 214 | Houston | Texas | United States | 77054 |
| 97 | Relmada Site 111 | Houston | Texas | United States | 77081 |
| 98 | Relmada Site 233 | Plano | Texas | United States | 75093 |
| 99 | Relmada Site 103 | Wichita Falls | Texas | United States | 76309 |
| 100 | Relmada Site 102 | Woodstock | Vermont | United States | 05091 |
| 101 | Relmada Site 156 | Charlottesville | Virginia | United States | 22903 |
| 102 | Relmada Site 108 | Everett | Washington | United States | 98201 |
| 103 | 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
Publications
None provided.Responsible Party:
Relmada Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT04855760
Other Study ID Numbers:
- REL-1017-310
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.
Additional relevant MeSH terms: