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

Sponsor

Relmada Therapeutics, Inc. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT06011577

Collaborator

(none)

300

Enrollment

Locations

Arms

15.5

Anticipated Duration (Months)

Patients Per Site

3.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Major Depressive Disorder Depression	Drug: REL-1017 Drug: Placebo	Phase 3

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 Design

Study Type:

Interventional

Anticipated Enrollment :

300 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

A Randomized, Double-Blind, Placebo-Controlled Trial of REL-1017 as an Adjunctive Treatment for Major Depressive Disorder (RELIGHT)

Actual Study Start Date :

Aug 17, 2023

Anticipated Primary Completion Date :

Dec 1, 2024

Anticipated Study Completion Date :

Dec 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: REL-1017 25 mg 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)	Drug: REL-1017 REL-1017 tablet Other Names: esmethadone
Placebo Comparator: 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)	Drug: Placebo Placebo tablet

Arm

Intervention/Treatment

Experimental: REL-1017 25 mg

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)

Drug: REL-1017

REL-1017 tablet

Other Names:

esmethadone

Placebo Comparator: 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)

Drug: Placebo

Placebo tablet

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Male or female outpatients, 18-65 years of age, inclusive.
Currently meets DSM-5 criteria for MDD without psychotic features, based on the SCID-5-CT, with a current major depressive episode (MDE).
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.
Breast-feeding or planning to breast-feed.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Relmada Site	Culver City	California	United States	90230
2	Relmada Site	Sherman Oaks	California	United States	91403
3	Relmada Site	Miami	Florida	United States	33174
4	Relmada Site	Baltimore	Maryland	United States	21208
5	Relmada Site	Springfield	Massachusetts	United States	33024
6	Relmada Site	Franklin	Tennessee	United States	37067