NCT05361330

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: Peking University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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).

Detailed description

Whole-course treatment serves as the principle for the treatment of depression, including symptom control in the acute phase, relapse prevention in the consolidation period and recurrence prevention in the maintenance period. Western medicine usually adopts antidepressant drugs combined with psychotherapy, mainly antidepressant SSRI at the current stage. It can selectively inhibit serotonin reuptake, so as to play an antidepressant role, but for somatic symptoms, the effect is general. Based on the overall regulation of body and mind, traditional Chinese medicine aims to achieve individualized treatment combing syndrome differentiation and treatment in a multi-channel, multi-target, and multi-level manner. At present, the combined application of antidepressant chemical drugs and Chinese patent medicines is complementary to each other from the perspective of mechanism and clinical practice. However, the study of Shuganjieyu capsule combined with antidepressant chemical drugs is mostly concentrated in the short term, and the benefits of long-term combined use of Shuganjieyu capsule remain to be further studied. The purpose of this multicenter clinical study is to evaluate the efficacy and safety of Shuganjieyu capsule combined with Fluoxetine as well as the Fluoxetine monotherapy in the basic study period. Besides, the study aims to continue to observe the efficacy and safety in the extended study research period, so as to provide important clinical data for the whole-course medication. Recruitment of outpatients / inpatients with depression. After screening the patients who met the inclusion criteria, the study collected demographic data, recorded symptoms and scale scores and improved relevant laboratory tests. The experimental group was treated with Shuganjieyu capsule combined with Fluoxetine, and the control group was treated with Fluoxetine. The related indexes were evaluated 2 ,4, 8, 12, 16 and 24 weeks later.

Conditions

• Outpatients / Inpatients With Depression

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-05-30
• Primary completion: 2023-04-30
• Completion: 2023-09-30
• First posted: 2022-05-04
• Last updated: 2022-05-17

Locations

3 sites across 1 country: China