A Study to Assess the Efficacy and Safety of REL-1017 as Adjunctive Treatment for Major Depressive Disorder (MDD)

Phase 3

Recruiting

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

• Registration Number: NCT04855747
• Lead Sponsor: Relmada Therapeutics, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-30
• Study First Submitted: 2021-04-19
• Study First Submitted QC: 2021-04-19
• Study First Posted: 2021-04-22
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-25
• Last Update Posted: 2024-07-26
• 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.
• 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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
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)
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).

Primary Outcome Measures

Name	Time	Method
Change in the MADRS10 total score	Day 28	Therapeutic efficacy of REL-1017 as adjunctive treatment versus placebo in the Montgomery-Asberg Depression Rating Scale (MADRS10). A higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6.; A negative change from baseline indicates improvement.

Secondary Outcome Measures

Name	Time	Method
Change in CGI-S score	Day 28	Therapeutic efficacy of REL-1017 as an adjunctive treatment versus placebo in Clinical Global Impression of Severity (CGI-S). The CGI-S is a standard method used in clinical studies to quantify and track patient progress and treatment response over time. The scale is composed of 7 ratings: 1 = normal, not at all ill; 2 = borderline ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill patients.; The score ranges from 1 to 7, and a lower CGI-S score indicates lower levels of depression.
Change in the MADRS10 total score	Day 7	MADRS10 score at Day 7.
MADRS10 Response Rater	Day 28	Improvement ≥50% compared with total Baseline score) at Day 28
MADRS10 Remission Rate	Day 28	MADRS10 remission rate (total score ≤10) at Day 28

Trial Locations

Locations (1)

Relmada Site; 🇺🇸 Everett, Washington, United States