NCT07253207

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

A Randomized, Double-Blind, Active-Controlled, Multicenter Phase III Clinical Trial Evaluating the Efficacy and Safety of Levomilnacipran Hydrochloride Extended-Release Capsules in the Treatment of Patients With Major Depressive Disorder (MDD)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 392 (actual)
• Sponsor: Zhejiang Huahai Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Major Depressive Disorder (MDD)

Interventions

Type	Name	Description
DRUG	Levomilnacipran Hydrochloride Extended-Release Capsules	Treatment period: 1. Levomilnacipran Hydrochloride Extended-Release Capsules 20mg/day is to be given orally, once daily, for 1-2 days in the first week of treatment. 2. Levomilnacipran Hydrochloride Extended-Release Capsules 40mg/day is to be given orally, once daily, for 3-7 days in the first week of treatment. 3. Levomilnacipran Hydrochloride Extended-Release Capsules 80mg/day is to be given orally, once daily, for the second week of treatment. 4. Levomilnacipran Hydrochloride Extended-Release Capsules 40, 80 or 120mg/day (the dosage based on the participant's clinical response and tolerance) is to be given orally, once daily, for the weeks 3 to 8 of treatment. Reduction period: Dosage of 20-80mg/day based on the tolerable dose during the 8th week of treatment.
DRUG	Duloxetine Hydrochloride Enteric Capsules	Treatment period: Duloxetine Hydrochloride Enteric Capsules 60mg/day is to be given orally, once daily, for 8 weeks. Reduction period: Duloxetine Hydrochloride Enteric Capsules 60mg/day is to be given orally, once daily, for 2 weeks.

Timeline

• Start date: 2024-10-17
• Primary completion: 2025-06-13
• Completion: 2025-07-22
• First posted: 2025-11-28
• Last updated: 2025-11-28

Locations

28 sites across 1 country: China