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

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Outpatients / Inpatients With Depression
• Intervention / Treatment: Drug: Shuganjieyu capsule; Drug: Fluoxetine

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.

• Study Type: Interventional
• Enrollment (Anticipated): 160
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tianmei Si, PhD., MD.; Phone Number: 861062723748; Email: sitianmei@bjmu.edu.cn

Study Locations

• China
  • Beijing, China
    • Institute of Mental Health, Peking University Sixth Hospital
    • Contact: Tianmei Si, PhD., MD.; Phone Number: 861062723748; Email: sitianmei@bjmu.edu.cn
    • Principal Investigator: Tianmei Si, PhD., MD
  • Jiangsu
    • Nanjing, Jiangsu, China, 210000
      • Nanjing Brain Hospital, Nanjing Medical University
      • Contact: Zhijian Yao, MD.; Phone Number: 86-025-82296670; Email: zjyao@njmu.edu.cn
  • Shanxi
    • Taiyuan, Shanxi, China, 030000
      • First Hospital, Shanxi Medical University
      • Contact: Zhifen Liu, MD.; Phone Number: 86-13703586547; Email: liuzhifen5518@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. In line with the diagnostic criteria for depression of Diagnostic and Statistical Manual of Mental Disorders (5th edition) (DSM-5);
2. Age: 18-65 (including 18 and 65), gender unlimited;
3. Hamilton Rating Scale for Depression (HAMD-17) score≥18 in the screening period, and the 13th score≥2;
4. For women of childbearing age, pregnancy test must be negative and not in lactation. The contraception measure must be accepted by the Investigators. Participants should agree to maintain this measure throughout the whole process;
5. Sign the informed consent form voluntarily and agree to participate in all visits, examinations and treatment as required by the trial protocol.

Exclusion Criteria:

1. Treatment-resistant depression (patients with poor clinical efficacy of antidepressants with two or more different mechanisms after sufficient and full course of treatment);
2. Patients who meet DSM-5 diagnostic criteria for other mental disorders (such as schizophrenia pedigree and other mental disorders, bipolar and related disorders, anxiety disorders, obsessive-compulsive and related disorders, somatic symptoms and related disorders);
3. Depression caused by psychoactive drugs;
4. Patients with severe suicide (HAMD-17 suicide score≥3) and injury tendency;
5. Patients with serious or unstable cardiovascular, cerebrovascular, liver, kidney, endocrine, digestive and blood diseases;
6. Depressive episodes secondary to other mental diseases or somatic diseases at an active stage;
7. ALT and AST values in the liver function examination are more than double the upper limit of reference value, or Scr value is above the upper limit of reference value;
8. Patients with a history of endocrine diseases such as hyperthyroidism and hypothyroidism who are currently active;
9. Patients who had undergone psychiatric surgery or electroconvulsive therapy in the past three months;
10. Anyone with an allergic constitution known or suspected to have an allergic history to Hypericum perforatum L., Eleutherococcus senticosus and Fluoxetine;
11. Those who have previously failed Shuganjieyu capsule or Fluoxetine treatment;
12. Women in pregnancy or lactation period. Women who plan to get pregnant during the study and within six months;
13. Patients with psychoactive substance abuse or dependence in the past 12 months;
14. Long-term use of caffeine and nicotine;
15. Patients who have received or are receiving any other clinical trial drug treatment within three months before the trial;
16. Patients who are taking drugs that interfere with the efficacy evaluation of the investigational drugs, and drugs that are forbidden to be used in combination with the test drugs. Patients who have received antidepressant drugs for systematical treatment within 4 weeks;
17. Those who are regarded as unsuitable by investigators for this clinical trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: The experimental group: Shuganjieyu capsule; Shuganjieyu capsule combined with Fluoxetine	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.
Placebo Comparator: The control group: Shuganjieyu capsule simulator; Fluoxetine monotherapy	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
17-item Hamilton depression rating scale (HAMD-17) total scores change	The change value of HAMD-17 total scores compared to the baseline (V1) after 8 weeks of treatment	Day 0 to Day 56

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
17-item Hamilton depression rating scale (HAMD-17) total scores change at early time points	The change value of HAMD-17 total scores compared to the baseline	Day 0 to Day 14, Day 0 to Day 28
Hamilton anxiety rating scale (HAMA) total score change	The change value of HAMA total scores compared to the baseline	Day 0 to Day 14, Day 0 to Day 28, Day 0 to Day 56
Patient Health Questionnaire-15 (PHQ-15) score change	The change value of PHQ-15 total scores compared to the baseline	Day 0 to Day 14, Day 0 to Day 28, Day 0 to Day 56
Clinical Global Impression (CGI) score change	The change value of CGI total scores compared to the baseline	Day 0 to Day 14, Day 0 to Day 28, Day 0 to Day 56
Pittsburgh Sleep Quality Index (PSQI) score change	The change value of PSQI total scores compared to the baseline	Day 0 to Day 14, Day 0 to Day 28, Day 0 to Day 56
Dimensional Anhedonia Rating Scale (DARS) total score change	The change value of DARS total scores compared to the baseline	Day 0 to Day 14, Day 0 to Day 28, Day 0 to Day 56
Temporal Experience of Pleasure Scale (TEPS) total score change	The change value of TEPS total scores compared to the baseline	Day 0 to Day 14, Day 0 to Day 28, Day 0 to Day 56
Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q-SF) total score change	The change value of Q-LES-Q-SF total scores compared to the baseline	Day 0 to Day 56

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
17-item Hamilton depression rating scale (HAMD-17) change in the extended period	The change value of total score comared to the Week 8 time point	Day 56 to Day 84, Day 56 to Day 112, Day 56 to Day 168
Relapse rate	When V4 shows clinical benefit after 8 weeks of treatment, the relapse rate of depression symptoms among participants after 12, 16, 24 weeks of treatment compared to V4 of 8-week treatment;	Day 56 to Day 84, Day 56 to Day 112, Day 56 to Day 168
the rate of changing medicines	The rate of changing medicines among participants with 8 weeks of treatment when V4 entering the extended study period	Day 56 to Day 168
Hamilton anxiety rating scale (HAMA) change in the extended period	The change value of total score comared to the Week 8 time point	Day 56 to Day 84, Day 56 to Day 112, Day 56 to Day 168
Clinical Global Impression (CGI) score change in the extended period	The change comared to the Week 8 time point	Day 56 to Day 84, Day 56 to Day 112, Day 56 to Day 168
Patient Health Questionnaire-15 (PHQ-15) score change in the extended period	The change comared to the Week 8 time point	Day 56 to Day 84, Day 56 to Day 112, Day 56 to Day 168
Pittsburgh Sleep Quality Index (PSQI) score change in the extended period	The change comared to the Week 8 time point	Day 56 to Day 84, Day 56 to Day 112, Day 56 to Day 168
Dimensional Anhedonia Rating Scale (DARS) total score change in the extended period	The change comared to the Week 8 time point	Day 56 to Day 84, Day 56 to Day 112, Day 56 to Day 168
Temporal Experience of Pleasure Scale (TEPS) total score change in the extended period	The change comared to the Week 8 time point	Day 56 to Day 84, Day 56 to Day 112, Day 56 to Day 168

Collaborators and Investigators

• Sponsor: Peking University
• Collaborators: Sichuan Jishengtang Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Anticipated): May 30, 2022
• Primary Completion (Anticipated): April 30, 2023
• Study Completion (Anticipated): September 30, 2023

Study Registration Dates

• First Submitted: April 20, 2022
• First Submitted That Met QC Criteria: April 28, 2022
• First Posted (Actual): May 4, 2022

Study Record Updates

• Last Update Posted (Actual): May 17, 2022
• Last Update Submitted That Met QC Criteria: May 15, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: depression; Shuganjieyu capsule
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Antidepressive Agents; Cytochrome P-450 Enzyme Inhibitors; Antidepressive Agents, Second-Generation; Cytochrome P-450 CYP2D6 Inhibitors; Fluoxetine
• Other Study ID Numbers: V2.0

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No