NCT06842992

A Phase II Study to Evaluate NH102 for Depression

A Multicenter, Randomized, Double-blind, Double-dummy, Placebo and Active-controlled, Dose-exploration Phase II Clinical Trial to Evaluate the Efficacy and Safety of NH102 in the Treatment of Depression

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 243 (actual)
• Sponsor: Jiangsu Nhwa Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This trial consists of three periods: a screening period (up to 2 weeks), a double-blind treatment period (6 weeks), and a tapering-off period/safety follow-up (1 week). The screening period may last up to 14 days and a minimum of 1 day. Baseline assessments will be conducted prior to randomization to confirm the eligibility of participants. A total of 240 patients with depression will be randomly assigned in a 1:1:1:1:1 ratio to three experimental drug groups (10 mg, 20 mg, and 30 mg), one active control group (duloxetine hydrochloride capsules 60 mg ), or one placebo group. The double-blind treatment period will last for 6 weeks, during which participants will take the assigned medications according to the specified dosing regimen and will be followed up at the end of weeks 1, 2, 4, and 6. After the treatment period, participants will enter a 1-week tapering-off period and will undergo safety follow-up at the end of week 7.

Conditions

• Major Depressive Disorder (MDD)

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-12-04
• Primary completion: 2025-07-30
• Completion: 2025-09-12
• First posted: 2025-02-24
• Last updated: 2025-12-01

Locations

1 site across 1 country: China