Clinical trial NCT04855747: A Study to Assess the Efficacy and Safety of REL-1017 as Adjunctive Treatment for Major Depressive Disorder (MDD)
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)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Major Depressive Disorder
Depression
Keywords: REL-1017
Relmada
NMDA Receptor Antagonist
Esmethadone
Adjunctive
Antidepressant
Reliance
Depression
Lead sponsor: Relmada Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2021-04-22
Enrollment: 236
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* Body mass index (BMI) between 18.0 and 35.0 kg/m2.
* Diagnosed with Major Depressive Disorder (MDD) based on Structured Clinical Interview for DSM-5 (SCID-5) for MDD.
* Current Major Depressive Episode (MDE).
* Treated on approved, stable first-line anti-depressant therapy with inadequate response to 1 to 3 valid courses of treatment with a depressant medication in the current MDE.

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.
* Poorly controlled diabetes as defined by HbA1c \> 7.5%, despite standard care. Subjects with HbA1c \>7.5% may continue in the study if approved by the Relmada Medical Monitor.
* Having received ketamine or esketamine within 60 days prior to Screening.

Primary outcomes:
measure: Change in the MADRS10 total score
timeFrame: Day 28
Secondary outcomes:
measure: Change in CGI-S score
timeFrame: Day 28
measure: Change in the MADRS10 total score
timeFrame: Day 7
measure: MADRS10 Remission Rate
timeFrame: Day 28
measure: MADRS10 Response Rater
timeFrame: Day 28
Other outcomes:
Locations:
city: Homewood
country: United States
facility: Relmada Site
state: Alabama
city: Chandler
country: United States
facility: Relmada Site
state: Arizona
city: Chandler
country: United States
facility: Relmada Site
state: Arizona
city: Phoenix
country: United States
facility: Relmada Site
state: Arizona
city: Tucson
country: United States
facility: Relmada Site
state: Arizona
city: Bryant
country: United States
facility: Relmada Site
state: Arkansas
city: Anaheim
country: United States
facility: Relmada Site
state: California
city: Bellflower
country: United States
facility: Relmada Site
state: California
city: Encino
country: United States
facility: Relmada Site
state: California
city: Lafayette
country: United States
facility: Relmada Site
state: California
city: Los Angeles
country: United States
facility: Relmada Site
state: California
city: Newport Beach
country: United States
facility: Relmada Site
state: California
city: Orange
country: United States
facility: Relmada Site
state: California
city: Redlands
country: United States
facility: Relmada Site
state: California
city: Santa Ana
country: United States
facility: Relmada Site
state: California
city: Stanford
country: United States
facility: Relmada Site
state: California
city: Temecula
country: United States
facility: Relmada Site
state: California
city: Upland
country: United States
facility: Relmada Site
state: California
city: Denver
country: United States
facility: Relmada Site
state: Colorado
city: Brandon
country: United States
facility: Relmada Site
state: Florida
city: Hialeah
country: United States
facility: Relmada Site
state: Florida
city: Jacksonville
country: United States
facility: Relmada Site
state: Florida
city: Maitland
country: United States
facility: Relmada Site
state: Florida
city: Miami Springs
country: United States
facility: Relmada Site
state: Florida
city: Miami
country: United States
facility: Relmada Site
state: Florida
city: Miami
country: United States
facility: Relmada Site
state: Florida
city: Miami
country: United States
facility: Relmada Site
state: Florida
city: Miami
country: United States
facility: Relmada Site
state: Florida
city: Miami
country: United States
facility: Relmada Site
state: Florida
city: Okeechobee
country: United States
facility: Relmada Site
state: Florida
city: Tampa
country: United States
facility: Relmada Site
state: Florida
city: West Palm Beach
country: United States
facility: Relmada Site
state: Florida
city: Savannah
country: United States
facility: Relmada Site
state: Georgia
city: Boise
country: United States
facility: Relmada Site
state: Idaho
city: Chicago
country: United States
facility: Relmada Site
state: Illinois
city: Chicago
country: United States
facility: Relmada Site
state: Illinois
city: Elgin
country: United States
facility: Relmada Site
state: Illinois
city: Overland Park
country: United States
facility: Relmada Site
state: Kansas
city: Marrero
country: United States
facility: Relmada Site
state: Louisiana
city: Baltimore
country: United States
facility: Relmada Site
state: Maryland
city: Bel Air
country: United States
facility: Relmada Site
state: Maryland
city: Gaithersburg
country: United States
facility: Relmada Site
state: Maryland
city: Boston
country: United States
facility: Relmada Site
state: Massachusetts
city: Bloomfield Hills
country: United States
facility: Relmada Site
state: Michigan
city: Mankato
country: United States
facility: Relmada Site
state: Minnesota
city: Weldon Spring
country: United States
facility: Relmada Site
state: Missouri
city: Las Vegas
country: United States
facility: Relmada Site
state: Nevada
city: Toms River
country: United States
facility: Relmada Site
state: New Jersey
city: Cedarhurst
country: United States
facility: Relmada Site
state: New York
city: Monroe
country: United States
facility: Relmada Site
state: North Carolina
city: Beachwood
country: United States
facility: Relmada Site
state: Ohio
city: Cincinnati
country: United States
facility: Relmada Site
state: Ohio
city: Cincinnati
country: United States
facility: Relmada Site
state: Ohio
city: Westlake
country: United States
facility: Relmada Site
state: Ohio
city: Philadelphia
country: United States
facility: Relmada Site
state: Pennsylvania
city: State College
country: United States
facility: Relmada Site
state: Pennsylvania
city: Memphis
country: United States
facility: Relmada Site
state: Tennessee
city: Austin
country: United States
facility: Relmada Site
state: Texas
city: Austin
country: United States
facility: Relmada Site
state: Texas
city: Beaumont
country: United States
facility: Relmada Site
state: Texas
city: Bellaire
country: United States
facility: Relmada Site
state: Texas
city: Dallas
country: United States
facility: Relmada Site
state: Texas
city: Friendswood
country: United States
facility: Relmada Site
state: Texas
city: Houston
country: United States
facility: Relmada Site
state: Texas
city: Sherman
country: United States
facility: Relmada Site
state: Texas
city: Wichita Falls
country: United States
facility: Relmada Site
state: Texas
city: Draper
country: United States
facility: Relmada Site
state: Utah
city: Rutland
country: United States
facility: Relmada Site
state: Vermont
city: Portsmouth
country: United States
facility: Relmada Site
state: Virginia
city: Everett
country: United States
facility: Relmada Site
state: Washington
Study officials:
affiliation: Relmada Therapeutics
name: Paul Greene, PhD
role: STUDY_DIRECTOR
References: