A Study to Assess the Efficacy and Safety of REL-1017 as Adjunctive Treatment for Major Depressive Disorder (MDD)
| 适应症 | Major Depressive Disorder, Depression |
|---|---|
| 分期 | 3期 |
| 申办方 | Levomecor Inc. |
| 状态 | 提前终止 |
| 受试者人数 | 236 人 |
| 干预（药物） | REL-1017 |
| 开始日期 | 2021年3月30日 |
| 完成日期 | 2024年12月31日 |
| 结果公布日 | 2026年7月10日 |
摘要
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) |
在 BENITIONS 中查看 查看 ClinicalTrials.gov 原文
同一适应症的其他试验
- CBT+ for Depression — University of Wisconsin, Madison
- Probing the Dorsolateral Prefrontal Cortex and Central Executive Network for Improving Neu — Stanford University
- Severe Asthma, MepolizumaB and Affect: SAMBA Study — University Hospital Southampton NHS Foundation Trust
- Randomized, Double-Blind, Placebo-Controlled Trial of REL-1017 as Adjunctive Treatment for — Levomecor Inc.
- Comparative Effectiveness Research Trial for Antidepressant Incomplete and Non-responders — Massachusetts General Hospital
- Individualized Functional Connectivity Targeting in aiTBS for Depression — Brigham and Women's Hospital