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

NCT04855747

TerminatedPhase 3

Sponsor: Levomecor Inc.

Conditions: Major Depressive Disorder, Depression

Interventions: REL-1017, Placebo

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 65 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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.

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.
Locations (70)
  • Homewood, Alabama, United States
  • Chandler, Arizona, United States
  • Chandler, Arizona, United States
  • Phoenix, Arizona, United States
  • Tucson, Arizona, United States
  • Bryant, Arkansas, United States
  • Anaheim, California, United States
  • Bellflower, California, United States
  • Encino, California, United States
  • Lafayette, California, United States
  • Los Angeles, California, United States
  • Newport Beach, California, United States
  • Orange, California, United States
  • Redlands, California, United States
  • Santa Ana, California, United States
  • Stanford, California, United States
  • Temecula, California, United States
  • Upland, California, United States
  • Denver, Colorado, United States
  • Brandon, Florida, United States
  • Hialeah, Florida, United States
  • Jacksonville, Florida, United States
  • Maitland, Florida, United States
  • Miami, Florida, United States
  • Miami, Florida, United States
  • Miami, Florida, United States
  • Miami, Florida, United States
  • Miami, Florida, United States
  • Miami Springs, Florida, United States
  • Okeechobee, Florida, United States
  • + 40 more on CT.gov