Clinical trial NCT06011577: Randomized, Double-Blind, Placebo-Controlled Trial of REL-1017 as Adjunctive Treatment for MDD
Official title: A Randomized, Double-Blind, Placebo-Controlled Trial of REL-1017 as an Adjunctive Treatment for Major Depressive Disorder (RELIGHT)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Major Depressive Disorder
Depression
Keywords: REL-1017
esmethadone
Relmada
antidepressant
adjunctive
NMDA receptor antagonist
Relight
Depression
Lead sponsor: Relmada Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2023-08-25
Enrollment: 27
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: A Phase 3, randomized, double-blind, placebo-controlled, multicenter trial of REL-1017 in patients with major depressive disorder (MDD).

Detailed description: 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 in patients with inadequate response to ongoing background antidepressant treatment. Eligible patients will continue to take their background antidepressant therapy and be randomized in a 1:1 ratio to treatment with REL-1017 or placebo for a 4 week 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.
* Inadequate response to 1 to 3 adequate antidepressant treatments in the current MDE.

Exclusion Criteria:

* Psychiatric hospitalization during the current major depressive episode.
* History or presence of clinically significant health conditions which in the opinion of the Investigator would negatively impact the safety of the participant.
* Participants who, in the Investigator's judgment, are at significant risk for suicide.
* Pregnant or planning to become pregnant.

Primary outcomes:
measure: Change in MADRS Total Score From Baseline to Day 28
timeFrame: Day 28
Secondary outcomes:
Other outcomes:
Locations:
city: Dothan
country: United States
facility: Relmada Site
state: Alabama
city: Homewood
country: United States
facility: Relmada Site
state: Alabama
city: Anaheim
country: United States
facility: Relmada Site
state: California
city: Lafayette
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: Sherman Oaks
country: United States
facility: Relmada Site
state: California
city: Farmington
country: United States
facility: Relmada Site
state: Connecticut
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: 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: Springfield
country: United States
facility: Relmada Site
state: Illinois
city: Baltimore
country: United States
facility: Relmada Site
state: Maryland
city: Mankato
country: United States
facility: Relmada Site
state: Minnesota
city: Toms River
country: United States
facility: Relmada Site
state: New Jersey
city: Brooklyn
country: United States
facility: Relmada Site
state: New York
city: Cedarhurst
country: United States
facility: Relmada Site
state: New York
city: New York
country: United States
facility: Relmada Site
state: New York
city: Philadelphia
country: United States
facility: Relmada Site
state: Pennsylvania
city: Franklin
country: United States
facility: Relmada Site
state: Tennessee
city: Memphis
country: United States
facility: Relmada Site
state: Tennessee
city: Austin
country: United States
facility: Relmada Site
state: Texas
city: Bellaire
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: Wichita Falls
country: United States
facility: Relmada Site
state: Texas
city: Clinton
country: United States
facility: Relmada Site
state: Utah
city: Draper
country: United States
facility: Relmada Site
state: Utah
city: Rutland
country: United States
facility: Relmada Site
state: Vermont
city: Charlottesville
country: United States
facility: Relmada Site
state: Virginia
city: Seattle
country: United States
facility: Relmada Site
state: Washington
Study officials:
affiliation: Relmada Therapeutics
name: Paul Greene, PhD
role: STUDY_DIRECTOR
References: