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COMPLETED
NCT05361330
NA

A Multicenter Clinical Study on Shuganjieyu Capsule Combined With Fluoxetine in the Treatment of Depression

Sponsor: Peking University

View on ClinicalTrials.gov

Summary

This study mainly evaluates the efficacy and safety of Shuganjieyu capsule combined with Fluoxetine as well as the Fluoxetine monotherapy for the treatment of depression in the basic study, and also explores the efficacy for the extended study period as well as the efficacy and safety for the full trial period (basic study period and extended study period).

Official title: A Multicenter Clinical Study to Evaluate the Efficacy and Safety of Shuganjieyu Capsule Combined With Fluoxetine in the Treatment of Depression

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

160

Start Date

2022-05-19

Completion Date

2024-05-29

Last Updated

2026-09-16

Healthy Volunteers

No

Interventions

DRUG

Shuganjieyu capsule

2 capsules each time, twice per day. According to the study progress, the intervention can be adjusted to 4 capsules each time, twice per day.

DRUG

Fluoxetine

Fluoxetine 20 mg, once a day. According to the study progress, the dosage can be adjusted to 40 mg , once per day.

DRUG

Placebo

Shuganjieyu capsule simulator 2 capsules each time, twice a day. According to the study progress, the intervention can be adjusted to 4 capsules each time, twice per day.

Locations (3)

Nanjing Brain Hospital, Nanjing Medical University

Nanjing, Jiangsu, China

First Hospital, Shanxi Medical University

Taiyuan, Shanxi, China

Institute of Mental Health, Peking University Sixth Hospital

Beijing, China