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NCT04855747TerminatedPhase 3

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

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)

Source: ClinicalTrials.gov · Last updated 10 Jul 2026

Brief summary (registry, in English)

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.

Status (registry)
Terminated
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
236 (actual)
First submitted
19 Apr 2021
Start date
30 Mar 2021
Primary completion date
31 Dec 2024
Lead sponsor
Levomecor Inc.
Diseases
Depression
NCT number
NCT04855747

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

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

Other illness

  • 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.

Lab values

  • 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.

Who the study is looking for

  • 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.

Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (62)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
-AnaheimUnited StatesUnknown status
-AustinUnited StatesUnknown status
-BaltimoreUnited StatesUnknown status
-BeachwoodUnited StatesUnknown status
-BeaumontUnited StatesUnknown status
-Bel AirUnited StatesUnknown status
-BellaireUnited StatesUnknown status
-BellflowerUnited StatesUnknown status
-Bloomfield HillsUnited StatesUnknown status
-BoiseUnited StatesUnknown status
-BostonUnited StatesUnknown status
-BrandonUnited StatesUnknown status
-BryantUnited StatesUnknown status
-CedarhurstUnited StatesUnknown status
-ChandlerUnited StatesUnknown status
-ChicagoUnited StatesUnknown status
-CincinnatiUnited StatesUnknown status
-DallasUnited StatesUnknown status
-DenverUnited StatesUnknown status
-DraperUnited StatesUnknown status
-ElginUnited StatesUnknown status
-EncinoUnited StatesUnknown status
-EverettUnited StatesUnknown status
-FriendswoodUnited StatesUnknown status
-GaithersburgUnited StatesUnknown status
-HialeahUnited StatesUnknown status
-HomewoodUnited StatesUnknown status
-HoustonUnited StatesUnknown status
-JacksonvilleUnited StatesUnknown status
-LafayetteUnited StatesUnknown status
-Las VegasUnited StatesUnknown status
-Los AngelesUnited StatesUnknown status
-MaitlandUnited StatesUnknown status
-MankatoUnited StatesUnknown status
-MarreroUnited StatesUnknown status
-MemphisUnited StatesUnknown status
-MiamiUnited StatesUnknown status
-Miami SpringsUnited StatesUnknown status
-MonroeUnited StatesUnknown status
-Newport BeachUnited StatesUnknown status
-OkeechobeeUnited StatesUnknown status
-OrangeUnited StatesUnknown status
-Overland ParkUnited StatesUnknown status
-PhiladelphiaUnited StatesUnknown status
-PhoenixUnited StatesUnknown status
-PortsmouthUnited StatesUnknown status
-RedlandsUnited StatesUnknown status
-RutlandUnited StatesUnknown status
-Santa AnaUnited StatesUnknown status
-SavannahUnited StatesUnknown status
-ShermanUnited StatesUnknown status
-StanfordUnited StatesUnknown status
-State CollegeUnited StatesUnknown status
-TampaUnited StatesUnknown status
-TemeculaUnited StatesUnknown status
-Toms RiverUnited StatesUnknown status
-TucsonUnited StatesUnknown status
-UplandUnited StatesUnknown status
-Weldon SpringUnited StatesUnknown status
-WestlakeUnited StatesUnknown status
-West Palm BeachUnited StatesUnknown status
-Wichita FallsUnited StatesUnknown status

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This page is information, not medical advice. Discuss any trial with your doctor.