Depression Clinical Trial
— RELIANCE-IIOfficial 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)
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.
| Status | Recruiting |
| Enrollment | 300 |
| Est. completion date | June 2024 |
| Est. primary completion date | June 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 65 Years |
| Eligibility | 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. - Any lifetime experience of having received ketamine or esketamine as a treatment for MDD, or as part of a clinical trial. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Relmada Site | Allentown | Pennsylvania |
| United States | Relmada Site | Austin | Texas |
| United States | Relmada Site | Austin | Texas |
| United States | Relmada Site | Baltimore | Maryland |
| United States | Relmada Site | Baytown | Texas |
| United States | Relmada Site | Beachwood | Ohio |
| United States | Relmada Site | Bellaire | Texas |
| United States | Relmada Site | Bellevue | Washington |
| United States | Relmada Site | Bellflower | California |
| United States | Relmada Site | Boise | Idaho |
| United States | Relmada Site | Boston | Massachusetts |
| United States | Relmada Site | Boston | Massachusetts |
| United States | Relmada Site | Bryant | Arkansas |
| United States | Relmada Site | Cedarhurst | New York |
| United States | Relmada Site | Chicago | Illinois |
| United States | Relmada Site | Chicago | Illinois |
| United States | Relmada Site | Cincinnati | Ohio |
| United States | Relmada Site | Cincinnati | Ohio |
| United States | Relmada Site | Culver City | California |
| United States | Relmada Site | Dallas | Texas |
| United States | Relmada Site | Denver | Colorado |
| United States | Relmada Site | Draper | Utah |
| United States | Relmada Site | Encino | California |
| United States | Relmada Site | Everett | Washington |
| United States | Relmada Site | Friendswood | Texas |
| United States | Relmada | Gaithersburg | Maryland |
| United States | Relmada Site | Gaithersburg | Maryland |
| United States | Relmada Site | Glendale | California |
| United States | Relmada Site | Hallandale Beach | Florida |
| United States | Relmada Site | Hialeah | Florida |
| United States | Relmada Site | Houston | Texas |
| United States | Relmada Site | Houston | Texas |
| United States | Relmada Site | Imperial | California |
| United States | Relmada Site | Jacksonville | Florida |
| United States | Relmada Site | La Jolla | California |
| United States | Relmada Site | Lafayette | California |
| United States | Relmada Site | Lake City | Florida |
| United States | Relmada Site | Lakeland | Florida |
| United States | Relmada Site | Las Vegas | Nevada |
| United States | Relmada Site | Memphis | Tennessee |
| United States | Relmada Site | Miami | Florida |
| United States | Relmada Site | Miami | Florida |
| United States | Relmada Site | Miami | Florida |
| United States | Relmada Site | Miami | Florida |
| United States | Relmada Site | Miami Springs | Florida |
| United States | Relmada Site | Middleburg Heights | Ohio |
| United States | Relmada Site | New York | New York |
| United States | Relmada Site | Newport Beach | California |
| United States | Relmada Site | Norwich | Connecticut |
| United States | Relmada Site | O'Fallon | Missouri |
| United States | Relmada Site | Okeechobee | Florida |
| United States | Relmada Site | Orange | California |
| United States | Relmada Site | Orange City | Florida |
| United States | Relmada Site | Overland Park | Kansas |
| United States | Relmada Site | Phoenix | Arizona |
| United States | Relmada Site | Phoenix | Arizona |
| United States | Relmada Site | Plano | Texas |
| United States | Relmada Site | Princeton | New Jersey |
| United States | Relmada Site | Redlands | California |
| United States | Relmada Site | San Diego | California |
| United States | Relmada Site | Saraland | Alabama |
| United States | Relmada Site | Savannah | Georgia |
| United States | Relmada Site | Stanford | California |
| United States | Relmada Site | Staten Island | New York |
| United States | Relmada Site | Tampa | Florida |
| United States | Relmada Site | Tampa | Florida |
| United States | Relmada Site | Tampa | Florida |
| United States | Relmada Site | Temecula | California |
| United States | Relmada Site | Toms River | New Jersey |
| United States | Relmada Site | Torrance | California |
| United States | Relmada Site | Upland | California |
| United States | Relmada Site | Watertown | Massachusetts |
| United States | Relmada Site | Waukesha | Wisconsin |
| United States | Relmada Site | Weldon Spring | Missouri |
| United States | Relmada Site | West Chester | Ohio |
| United States | Relmada Site | West Palm Beach | Florida |
| United States | Relmada Site | Wichita Falls | Texas |
| United States | Relmada Site | Winter Park | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| Relmada Therapeutics, Inc. |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 Oto 60 with scores above 34 indicating severe depression.
A negative change from baseline indicates improvement. |
Day 28 | |
| Secondary | 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. |
Day 28 | |
| Secondary | 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 Oto 60 with scores above 34 indicating severe depression.
A negative change from baseline indicates improvement. |
Day 7 |
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