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

Phase 3TerminatedNCT06011577

Levomecor Inc.27 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Major Depressive Disorder Depression

Interventions

REL-1017DRUG

REL-1017 tablet

PlaceboDRUG

Placebo tablet

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (36)

Outcomes

Primary Outcomes

Change From Baseline to Day 28 in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score

Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score. The MADRS is a clinician-rated scale that assesses the severity of depressive symptoms. The total score is calculated as the sum of 10 items, each scored from 0 to 6, resulting in a total score range of 0 to 60. Lower scores indicate less severe depressive symptoms and a better outcome, whereas higher scores indicate more severe depressive symptoms and a worse outcome. The outcome measure reports the change in MADRS total score from Baseline to Day 28. Change was calculated as Day 28 score minus Baseline score.

Time frame: Baseline and Day 28

Secondary Outcomes

Change From Baseline to Day 7 in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score

Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score. The MADRS is a clinician-rated scale that assesses the severity of depressive symptoms. The total score is calculated as the sum of 10 items, each scored from 0 to 6, resulting in a total score range of 0 to 60. Lower scores indicate less severe depressive symptoms and a better outcome, whereas higher scores indicate more severe depressive symptoms and a worse outcome. The outcome measure reports the change in MADRS total score from Baseline to Day 7.Change was calculated as Day 7 score minus Baseline score.

Time frame: Baseline and Day 7

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Relmada Site

Dothan, Alabama, United States

Relmada Site

Homewood, Alabama, United States

Relmada Site

Anaheim, California, United States

Relmada Site

Lafayette, California, United States

Relmada Site

Newport Beach, California, United States

Relmada Site

Orange, California, United States

Relmada Site

Redlands, California, United States

Relmada Site

Sherman Oaks, California, United States

Relmada Site

Farmington, Connecticut, United States

Relmada Site

Brandon, Florida, United States

...and 26 more locations