NCT06827431

The Research of Ammoxetine Hydrochloride Enteric-coated Tablets in Subjects With Depression

Efficacy and Safety of Ammoxetine Hydrochloride Enteric-coated Tablets in Subjects With Depression: A Multicenter, Randomized, Double-blind, Double-Dummy, Placebo-controlled and Sertraline Active-controlled, Parallel-group, Phase III Study

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 770 (estimated)
• Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy and safety of Ammoxetine hydrochloride enteric-coated tablets in subjects with depression.

Detailed description

In this study, a randomized, double-blind, double-dummy, placebo-controlled and Sertraline active-controlled multicenter study will be conducted to evaluate the efficacy and safety of different doses of Ammoxetine hydrochloride enteric coated tablets in the treatment of depression.

Conditions

• Major Depressive Disorder (MDD)

Interventions

Type	Name	Description
DRUG	Ammoxetine	Drug: Ammoxetine Ammoxetine hydrochloride enteric-coated tablets Drug: Placebo placebo to Ammoxetine and Sertraline.
DRUG	Ammoxetine	Drug: Ammoxetine Ammoxetine hydrochloride enteric-coated tablets Drug: Placebo placebo to Sertraline.
DRUG	Placebo	Drug: Placebo placebo to Ammoxetine hydrochlorid and Sertraline.
DRUG	Sertraline	Drug: Sertraline positive control Drug: Placebo placebo to Ammoxetine hydrochlorid.

Timeline

• Start date: 2025-02-14
• Primary completion: 2026-06-30
• Completion: 2026-09-30
• First posted: 2025-02-14
• Last updated: 2025-02-14