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

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Major Depressive Disorder, Depression

In brief

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.

Key facts

Study ID

NCT04855747

Run by

Levomecor Inc.

People needed

236

Starts

2021-03-30

Expected to finish

2025-01-14

Last updated by the study team

2026-07-10

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Relmada Site — Chandler, Arizona, United States
• Relmada Site — Chandler, Arizona, United States
• Relmada Site — Phoenix, Arizona, United States
• Relmada Site — Tucson, Arizona, United States
• Relmada Site — Bryant, Arkansas, United States
• Relmada Site — Anaheim, California, United States
• Relmada Site — Bellflower, California, United States
• Relmada Site — Encino, California, United States
• Relmada Site — Lafayette, California, United States
• Relmada Site — Los Angeles, California, United States
• Relmada Site — Newport Beach, California, United States
• Relmada Site — Orange, California, United States
• Relmada Site — Redlands, California, United States
• Relmada Site — Santa Ana, California, United States
• Relmada Site — Stanford, California, United States
• Relmada Site — Temecula, California, United States
• Relmada Site — Upland, California, United States
• Relmada Site — Denver, Colorado, United States
• Relmada Site — Brandon, Florida, United States
• Relmada Site — Hialeah, Florida, United States
• Relmada Site — Jacksonville, Florida, United States
• Relmada Site — Maitland, Florida, United States
• Relmada Site — Miami, Florida, United States
• Relmada Site — Miami, Florida, United States
• Relmada Site — Homewood, Alabama, United States

Full record on ClinicalTrials.gov

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