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

Major Depressive Disorder Clinical Trial

— Reliance I  

Official title:

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of REL-1017 as Adjunctive Treatment of Major Depressive Disorder (The RELIANCE-I Study)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04688164
• Other study ID #: REL-1017-301
• Status: Completed
• Phase: Phase 3
• Start date: January 8, 2021
• Est. completion date: November 10, 2022

Study information

• Verified date: May 2024
• Source: Relmada Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 227
• Est. completion date: November 10, 2022
• Est. primary completion date: November 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Adults 18 to 65 years, inclusive.

• Diagnosed with Major Depressive Disorder (MDD) based on structured clinical interview for Diagnostic and Statistical Manual of Mental Disorders, DSM-5 (SCID-5) for MDD.

• Current major depressive episode.

• With inadequate response to 1-3 first-line antidepressants administered at an adequate and stable dose

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.

• Acute or chronic condition that, in the Investigator's opinion, would limit the subject's ability to complete or participate in this clinical study.

• Prior participation in a ketamine, esketamine, dextromethorphan or any other NMDAR- antagonist study, or received esketamine at any time.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Drug:
• REL-1017
REL-1017 tablet
• Placebo
Placebo tablet

Locations

Country	Name	City	State
United States	Relmada Site	Austin	Texas
United States	Relmada Site	Boston	Massachusetts
United States	Relmada Site	Chicago	Illinois
United States	Relmada Site	Cincinnati	Ohio
United States	Relmada Site	Decatur	Georgia
United States	Relmada Site	Miami	Florida
United States	Relmada Site	Miami Springs	Florida
United States	Relmada Site	New York	New York
United States	Relmada Site	O'Fallon	Missouri
United States	Relmada Site	Palm Bay	Florida
United States	Relmada Site	Watertown	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Relmada Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the MADRS10 Total Score From Baseline to 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. The overall score ranges from 0 to 60 with scores above 34 indicating severe depression.; A negative change from baseline indicates improvement.	Day 28
Secondary	MADRS10 Remission Rate (Total Score =10) at Day 28	Therapeutic remission rate with REL-1017 as adjunctive treatment versus placebo in the Montgomery-Asberg Depression Rating Scale (MADRS10). Remission is defined as MADRS10 Total Score =10 at Day 28. A higher percentage of remission indicates a higher percentage of subjects with MADRS10 Total Score =10 at Day 28.	Day 28
Secondary	MADRS10 Response Rate (Improvement =50% Compared With Total Baseline Score) at Day 28	Therapeutic response to REL-1017 as adjunctive treatment versus placebo in the Montgomery-Asberg Depression Rating Scale (MADRS10). Response rate is defined as an improvement =50% compared with total Baseline MADRS10 score.	Day 28

External Links

•   Study Homepage