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

NCT07253207 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 392

Last updated 2025-11-28

No results posted yet for this study

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

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.

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.

Sponsors & Collaborators

  • Zhejiang Huahai Pharmaceutical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07253207 on ClinicalTrials.gov