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

Last updated: January 15, 2025
Sponsor: Relmada Therapeutics, Inc.
Overall Status: Terminated

Phase

3

Condition

Depression

Depression (Major/severe)

Depression (Adult And Geriatric)

Treatment

REL-1017

Placebo

Clinical Study ID

NCT06011577
REL-1017-304
  • Ages 18-65
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Body mass index (BMI) between 18.0 and 35.0 kg/m2.

  • Diagnosed with Major Depressive Disorder (MDD) based on Structured ClinicalInterview for DSM-5 (SCID-5) for MDD.

  • Inadequate response to 1 to 3 adequate antidepressant treatments in the current MDE.

Exclusion

Exclusion Criteria:

  • Psychiatric hospitalization during the current major depressive episode.

  • History or presence of clinically significant health conditions which in the opinionof the Investigator would negatively impact the safety of the participant.

  • Participants who, in the Investigator's judgment, are at significant risk forsuicide.

  • Pregnant or planning to become pregnant.

Study Design

Total Participants: 27
Treatment Group(s): 2
Primary Treatment: REL-1017
Phase: 3
Study Start date:
August 17, 2023
Estimated Completion Date:
December 19, 2024

Study 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.

Connect with a study center

  • Relmada Site

    Dothan, Alabama 36303
    United States

    Site Not Available

  • Relmada Site

    Homewood, Alabama 35209
    United States

    Site Not Available

  • Relmada Site

    Bryant, Arkansas 72022
    United States

    Site Not Available

  • Relmada Site

    Anaheim, California 92805
    United States

    Site Not Available

  • Relmada Site

    Culver City, California 90230
    United States

    Site Not Available

  • Relmada Site

    Lafayette, California 94549
    United States

    Site Not Available

  • Relmada Site

    Newport Beach, California 92660
    United States

    Site Not Available

  • Relmada Site

    Orange, California 92868
    United States

    Site Not Available

  • Relmada Site

    Rancho Cucamonga, California 91730
    United States

    Site Not Available

  • Relmada Site

    Redlands, California 92374
    United States

    Site Not Available

  • Relmada Site

    Sherman Oaks, California 91403
    United States

    Site Not Available

  • Relmada Site

    Farmington, Connecticut 06030
    United States

    Site Not Available

  • Relmada Site

    Brandon, Florida 33511
    United States

    Site Not Available

  • Relmada Site

    Hialeah, Florida 33027
    United States

    Site Not Available

  • Relmada Site

    Jacksonville, Florida 32256
    United States

    Site Not Available

  • Relmada Site

    Miami, Florida 33174
    United States

    Site Not Available

  • Relmada Site

    Okeechobee, Florida 34972
    United States

    Site Not Available

  • Relmada Site

    Tampa, Florida 33607
    United States

    Site Not Available

  • Relmada Site

    Chicago, Illinois 60604
    United States

    Site Not Available

  • Relmada Site

    Springfield, Illinois 62794
    United States

    Site Not Available

  • Relmada Site

    Baltimore, Maryland 21208
    United States

    Site Not Available

  • Relmada Site

    Mankato, Minnesota 56001
    United States

    Site Not Available

  • Relmada Site

    Toms River, New Jersey 08755
    United States

    Site Not Available

  • Relmada Site

    Albuquerque, New Mexico 87109
    United States

    Site Not Available

  • Relmada Site

    Brooklyn, New York 11235
    United States

    Site Not Available

  • Relmada Site

    Cedarhurst, New York 11516
    United States

    Site Not Available

  • Relmada Site

    New York, New York 10036
    United States

    Site Not Available

  • Relmada Site

    West Chester, Ohio 45069
    United States

    Site Not Available

  • Relmada Site

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • Relmada Site

    Franklin, Tennessee 37067
    United States

    Site Not Available

  • Relmada Site

    Memphis, Tennessee 38119
    United States

    Site Not Available

  • Relmada Site

    Austin, Texas 78712
    United States

    Site Not Available

  • Relmada Site

    Bellaire, Texas 77401
    United States

    Site Not Available

  • Relmada Site

    Friendswood, Texas 77546
    United States

    Site Not Available

  • Relmada Site

    Houston, Texas 77030
    United States

    Site Not Available

  • Relmada Site

    Wichita Falls, Texas 76309
    United States

    Site Not Available

  • Relmada Site

    Clinton, Utah 84015
    United States

    Site Not Available

  • Relmada Site

    Draper, Utah 84020
    United States

    Site Not Available

  • Relmada Site

    Rutland, Vermont 05701
    United States

    Site Not Available

  • Relmada Site

    Charlottesville, Virginia 22903
    United States

    Site Not Available

  • Relmada Site

    Seattle, Washington 98104
    United States

    Site Not Available

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