MedTrace Logo

A Phase II Study to Evaluate NH102 for Depression

NCT06842992 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 243

Last updated 2025-12-01

No results posted yet for this study

Summary

This study is a multicenter, randomized, double-blind, double-dummy, parallel-group, dose-finding Phase II clinical trial with placebo and active comparator duloxetine . It is designed to preliminarily assess the efficacy and safety of NH102 in patients with major depressive disorder and to provide the basis for the design of Phase III clinical trials.

Conditions

  • Major Depressive Disorder (MDD)

Interventions

DRUG

NH102

5 mg twice daily over 6 weeks, followed by a 1-week tapering period.

DRUG

NH102

10 mg twice daily over 6 weeks, followed by a 1-week tapering period.

DRUG

NH102

15 mg twice daily over 6 weeks, followed by a 1-week tapering period.

DRUG

Duloxetine Hydrochloride Enteric-coated Capsule

30 mg twice daily for 6 weeks, followed by a 1-week tapering period.

DRUG

Placebo

Matched dosing regimen.Twice daily for 6 weeks, followed by a 1-week tapering period.

Sponsors & Collaborators

  • Jiangsu Nhwa Pharmaceutical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2024-12-04
Primary Completion
2025-07-30
Completion
2025-09-12

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

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 NCT06842992 on ClinicalTrials.gov