drugset / Trial / NCT07253207

Efficacy and Safety Study of Levomilnacipran Hydrochloride Extended-Release Capsules in Major Depressive Disorder

NCT07253207

Phase 3 Completed 392 enrolled Zhejiang Huahai Pharmaceutical Co., Ltd.
RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this study is using Duloxetine Hydrochloride Enteric Capsules as the positive control, to evaluate the efficacy and safety of Levomilnacipran Hydrochloride Extended-Release Capsules in patients with Major Depressive Disorder (MDD).

Timeline

Start
2024-10-17
Primary completion
2025-06-13
Completion
2025-07-22

Drugs

EvaluationDrugModalityDoseRoute
Comparator Duloxetine Small molecule 60 mg Oral
Subject Levomilnacipran Small molecule 40 mg Oral
Subject Levomilnacipran Small molecule 80 mg Oral
Subject Levomilnacipran Small molecule 120 mg Oral