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

NCT05361330 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2022-05-17

No results posted yet for this study

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).

Conditions

  • Outpatients / Inpatients With Depression

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

Medication in basic study period: Fluoxetine (20 mg, once a day) Medication in the expanded study period: After 8 weeks of basic study period, if the reduction rate of HAMD-17 total scores is below 50 %, for the treatment group, the dosage of Fluoxetine will be adjusted to 40 mg / time, once a day.

Sponsors & Collaborators

  • Sichuan Jishengtang Pharmaceutical Co., Ltd.

    collaborator INDUSTRY

  • Peking University

    lead OTHER

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
2022-05-30
Primary Completion
2023-04-30
Completion
2023-09-30

Countries

  • China

Study Locations

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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 NCT05361330 on ClinicalTrials.gov