EICHORCondition: Major Depressive Disorder · Depression · Sponsor: Levomecor Inc.
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.
This description comes directly from the study's public registry record.
No contact information is available for this study as per the public registry record.
Always discuss trial participation with your own doctor first.
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. * 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. Exclusion Criteria: * 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.
Reproduced word-for-word from the public registry record — the study team can answer questions about it.
| Relmada Site | Homewood, Alabama, United States | — |
| 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 | — |
+ 58 more locations — full list on the registry record.
This study lists sites in the areas below. Each link shows other recruiting studies near that city, from the public registry record.
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Source record: clinicaltrials.gov/study/NCT04855747