TERMINATED

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

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Conditions

Major Depressive DisorderDepressionREL-1017RelmadaNMDA Receptor AntagonistEsmethadoneAdjunctiveAntidepressantReliance

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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. 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.

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-II Study)

Quick Facts

Study Start:2021-03-30
Study Completion:2025-01-14
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:TERMINATED

Study ID

NCT04855747

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Body mass index (BMI) between 18.0 and 35.0 kg/m2.
  2. * Diagnosed with Major Depressive Disorder (MDD) based on Structured Clinical Interview for DSM-5 (SCID-5) for MDD.
  3. * Current Major Depressive Episode (MDE).
  4. * 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.
  1. * Any current and primary psychiatric disorder other than Major Depressive Disorder.
  2. * Severe alcohol or substance use disorder.
  3. * History of bipolar I and II disorder, psychosis, and/or mania.
  4. * 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.
  5. * Having received ketamine or esketamine within 60 days prior to Screening.

Contacts and Locations

Principal Investigator

Paul Greene, PhD
STUDY_DIRECTOR
Relmada Therapeutics

Study Locations (Sites)

Relmada Site
Homewood, Alabama, 35209
United States
Relmada Site
Chandler, Arizona, 85226
United States
Relmada Site
Chandler, Arizona, 85286
United States
Relmada Site
Phoenix, Arizona, 85016
United States
Relmada Site
Tucson, Arizona, 85704
United States
Relmada Site
Bryant, Arkansas, 72022
United States
Relmada Site
Anaheim, California, 92805
United States
Relmada Site
Bellflower, California, 90706
United States
Relmada Site
Encino, California, 91316
United States
Relmada Site
Lafayette, California, 94549
United States
Relmada Site
Los Angeles, California, 90015
United States
Relmada Site
Newport Beach, California, 92660
United States
Relmada Site
Orange, California, 92868
United States
Relmada Site
Redlands, California, 92374
United States
Relmada Site
Santa Ana, California, 92705
United States
Relmada Site
Stanford, California, 94305
United States
Relmada Site
Temecula, California, 92591
United States
Relmada Site
Upland, California, 91786
United States
Relmada Site
Denver, Colorado, 80209
United States
Relmada Site
Brandon, Florida, 33511
United States
Relmada Site
Hialeah, Florida, 33015
United States
Relmada Site
Jacksonville, Florida, 32256
United States
Relmada Site
Maitland, Florida, 32751
United States
Relmada Site
Miami Springs, Florida, 33166
United States
Relmada Site
Miami, Florida, 33122
United States
Relmada Site
Miami, Florida, 33125
United States
Relmada Site
Miami, Florida, 33133
United States
Relmada Site
Miami, Florida, 33136
United States
Relmada Site
Miami, Florida, 33174
United States
Relmada Site
Okeechobee, Florida, 34972
United States
Relmada Site
Tampa, Florida, 33607
United States
Relmada Site
West Palm Beach, Florida, 33407
United States
Relmada Site
Savannah, Georgia, 31406
United States
Relmada Site
Boise, Idaho, 83704
United States
Relmada Site
Chicago, Illinois, 60611
United States
Relmada Site
Chicago, Illinois, 60634
United States
Relmada Site
Elgin, Illinois, 60123
United States
Relmada Site
Overland Park, Kansas, 66210
United States
Relmada Site
Marrero, Louisiana, 70072
United States
Relmada Site
Baltimore, Maryland, 21208
United States
Relmada Site
Bel Air, Maryland, 21015
United States
Relmada Site
Gaithersburg, Maryland, 20877
United States
Relmada Site
Boston, Massachusetts, 02131
United States
Relmada Site
Bloomfield Hills, Michigan, 48302
United States
Relmada Site
Mankato, Minnesota, 56001
United States
Relmada Site
Weldon Spring, Missouri, 63304
United States
Relmada Site
Las Vegas, Nevada, 89121
United States
Relmada Site
Toms River, New Jersey, 08755
United States
Relmada Site
Cedarhurst, New York, 11516
United States
Relmada Site
Monroe, North Carolina, 28112
United States
Relmada Site
Beachwood, Ohio, 44122
United States
Relmada Site
Cincinnati, Ohio, 45215
United States
Relmada Site
Cincinnati, Ohio, 45219
United States
Relmada Site
Westlake, Ohio, 44145
United States
Relmada Site
Philadelphia, Pennsylvania, 19104
United States
Relmada Site
State College, Pennsylvania, 16801
United States
Relmada Site
Memphis, Tennessee, 38119
United States
Relmada Site
Austin, Texas, 78737
United States
Relmada Site
Austin, Texas, 78759
United States
Relmada Site
Beaumont, Texas, 77702
United States
Relmada Site
Bellaire, Texas, 77401
United States
Relmada Site
Dallas, Texas, 75243
United States
Relmada Site
Friendswood, Texas, 77546
United States
Relmada Site
Houston, Texas, 77081
United States
Relmada Site
Sherman, Texas, 75092
United States
Relmada Site
Wichita Falls, Texas, 76309
United States
Relmada Site
Draper, Utah, 84020
United States
Relmada Site
Rutland, Vermont, 05701
United States
Relmada Site
Portsmouth, Virginia, 23703
United States
Relmada Site
Everett, Washington, 98201
United States

Collaborators and Investigators

Sponsor: Relmada Therapeutics, Inc.

  • Paul Greene, PhD, STUDY_DIRECTOR, Relmada Therapeutics

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-03-30
Study Completion Date2025-01-14

Study Record Updates

Study Start Date2021-03-30
Study Completion Date2025-01-14

Terms related to this study

Keywords Provided by Researchers

  • REL-1017
  • Relmada
  • NMDA Receptor Antagonist
  • Esmethadone
  • Adjunctive
  • Antidepressant
  • Reliance
  • Depression

Additional Relevant MeSH Terms

  • Major Depressive Disorder
  • Depression