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

NCT06011577

TerminatedPhase 3

Sponsor: Levomecor Inc.

Conditions: Major Depressive Disorder, Depression

Interventions: REL-1017, Placebo

Countries: United States

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

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.
* 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.
Locations (36)
  • Dothan, Alabama, United States
  • Homewood, Alabama, United States
  • Anaheim, California, United States
  • Lafayette, California, United States
  • Newport Beach, California, United States
  • Orange, California, United States
  • Redlands, California, United States
  • Sherman Oaks, California, United States
  • Farmington, Connecticut, United States
  • Brandon, Florida, United States
  • Hialeah, Florida, United States
  • Jacksonville, Florida, United States
  • Miami, Florida, United States
  • Miami, Florida, United States
  • Okeechobee, Florida, United States
  • Tampa, Florida, United States
  • Springfield, Illinois, United States
  • Baltimore, Maryland, United States
  • Mankato, Minnesota, United States
  • Toms River, New Jersey, United States
  • Brooklyn, New York, United States
  • Cedarhurst, New York, United States
  • New York, New York, United States
  • Philadelphia, Pennsylvania, United States
  • Franklin, Tennessee, United States
  • Memphis, Tennessee, United States
  • Austin, Texas, United States
  • Bellaire, Texas, United States
  • Friendswood, Texas, United States
  • Houston, Texas, United States
  • + 6 more on CT.gov