Randomized, Double-Blind, Placebo-Controlled Trial of REL-1017 as Adjunctive Treatment for MDD (RELIGHT)

Levomecor Inc.

Status and phase: Terminated; Phase 3

Conditions: Major Depressive Disorder; Depression

Treatments: Drug: Placebo; Drug: REL-1017

Study type: Interventional

Funder types: Industry

Identifiers

NCT06011577

REL-1017-304

Details and patient eligibility

About

A Phase 3, randomized, double-blind, placebo-controlled, multicenter trial of REL-1017 in patients with major depressive disorder (MDD).

Full 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.

Enrollment: 27 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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27 participants in 2 patient groups, including a placebo group

REL-1017 25 mg

Experimental group

Description:

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)

Treatment:

Drug: REL-1017

Placebo

Placebo Comparator group

Description:

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)

Treatment:

Drug: Placebo