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

Phase 3

Recruiting

• Conditions: Major Depressive Disorder; Depression
• Interventions: Drug: Placebo; Drug: REL-1017

• Registration Number: NCT06011577
• Lead Sponsor: Relmada Therapeutics, Inc.

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.

Study Timeline

• Study Start: 2023-08-17
• Study First Submitted: 2023-08-21
• Study First Submitted QC: 2023-08-21
• Study First Posted: 2023-08-25
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-31
• Last Update Posted: 2024-08-01
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 340

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	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)
REL-1017 25 mg	REL-1017	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)

Primary Outcome Measures

Name	Time	Method
Change in MADRS Total Score From Baseline to Day 28	Day 28	The MADRS is a 10-item scale and items are scored between 0-6 points. For each item, a score of 0 indicates the absence of symptoms, and a score of 6 indicates symptoms of maximum severity. A maximum total score is 60 points.

Trial Locations

Locations (1)

Relmada Site; 🇺🇸 Seattle, Washington, United States