A Study to Assess the Efficacy and Safety of REL-1017 as Adjunctive Treatment for Major Depressive Disorder (MDD)
| 대상 질환 | Major Depressive Disorder, Depression |
|---|---|
| 임상 단계 | 3상 |
| 스폰서 | Levomecor Inc. |
| 상태 | 조기 종료 |
| 참여자 수 | 236 명 |
| 중재(약물) | REL-1017 |
| 시작일 | 2021년 3월 30일 |
| 완료일 | 2024년 12월 31일 |
| 결과 공개일 | 2026년 7월 10일 |
요약
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.
Change From Baseline to Day 28 in MADRS Total Score
| REL-1017 | -14.81 ± 1.00 Scores on a scale (MADRS10) |
|---|---|
| Placebo | -13.9 ± 1.01 Scores on a scale (MADRS10) |
BENITIONS에서 보기 ClinicalTrials.gov 원문 보기
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