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A Multicenter Clinical Study on Shuganjieyu Capsule Combined With Fluoxetine in the Treatment of Depression
Sponsor: Peking University
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
Conditions
Interventions
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.
Fluoxetine
Fluoxetine 20 mg, once a day. According to the study progress, the dosage can be adjusted to 40 mg , once per day.
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