Purpose

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.

Conditions

Eligibility

Eligible Ages
Between 18 Years and 65 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Body mass index (BMI) between 18.0 and 32.0 kg. - 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.

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. - Having received ketamine or esketamine within 60 days prior to Screening.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
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

Recruiting Locations

More Details

Status
Recruiting
Sponsor
Relmada Therapeutics, Inc.

Study Contact

Medical Director
786-638-7384
clinicaltrials@relmada.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.