Outpatients / Inpatients With DepressionNCT05361330

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

A study testing Shuganjieyu capsule and Fluoxetine in people with Outpatients / Inpatients With Depression, run by Peking University at 3 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Outpatients / Inpatients With Depression
What is being tested?: Shuganjieyu capsule and Fluoxetine
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 160 participants
Where: 3 sitesChina
Study dates: 19 May 2022to 29 May 2024
Phase: Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

In line with the diagnostic criteria for depression of Diagnostic and Statistical Manual of Mental Disorders (5th edition) (DSM-5);
Age: 18-65 (including 18 and 65), gender unlimited;
Hamilton Rating Scale for Depression (HAMD-17) score≥18 in the screening period, and the 13th score≥2;
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;
Sign the informed consent form voluntarily and agree to participate in all visits, examinations and treatment as required by the trial protocol.

Who cannot join

Treatment-resistant depression (patients with poor clinical efficacy of antidepressants with two or more different mechanisms after sufficient and full course of treatment);
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);
Depression caused by psychoactive drugs;
Patients with severe suicide (HAMD-17 suicide score≥3) and injury tendency;
Patients with serious or unstable cardiovascular, cerebrovascular, liver, kidney, endocrine, digestive and blood diseases;
Depressive episodes secondary to other mental diseases or somatic diseases at an active stage;

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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;
Patients with a history of endocrine diseases such as hyperthyroidism and hypothyroidism who are currently active;
Patients who had undergone psychiatric surgery or electroconvulsive therapy in the past three months;
Anyone with an allergic constitution known or suspected to have an allergic history to Hypericum perforatum L., Eleutherococcus senticosus and Fluoxetine;
Those who have previously failed Shuganjieyu capsule or Fluoxetine treatment;
Women in pregnancy or lactation period. Women who plan to get pregnant during the study and within six months;
Patients with psychoactive substance abuse or dependence in the past 12 months;
Long-term use of caffeine and nicotine;
Patients who have received or are receiving any other clinical trial drug treatment within three months before the trial;
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;
Those who are regarded as unsuitable by investigators for this clinical trial.

Trial locations and contacts

3 sites in 1 country.

China3 sites

Institute of Mental Health, Peking University Sixth Hospital
Beijing
Nanjing Brain Hospital, Nanjing Medical University
Nanjing, Jiangsu, 210000
First Hospital, Shanxi Medical University
Taiyuan, Shanxi, 030000

Other trials in China

About this study

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

Read the 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
Being tested: Shuganjieyu capsule, Fluoxetine, Placebo
Keywords: Shuganjieyu capsule, depression
Medical subject headings: Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT05361330
Study group	Role	What they receive
The experimental group: Shuganjieyu capsule + Fluoxetine	Experimental	(1) Medication in basic study period (within 8 weeks): the experimental group was treated with Shuganjieyu capsule (2 capsules each time, twice a day) + Fluoxetine (20 mg, once a day). After 2 weeks of treatment, the reduction rate of HAMD-17 total scores was less than 20 %. The dosage of Shuganjieyu capsule was adjusted to 4 capsules each time, twice a day. (2) Medication in the expanded study period (after 8 weeks): After 8 weeks of basic study period, if the reduction rate of HAMD-17 total scores is below 50 %, the dosage of Fluoxetine will be adjusted to 40 mg / time, once a day. Receives: Drug: Shuganjieyu capsule; Drug: Fluoxetine
The control group: Fluoxetine	Placebo comparator	(1) Medication in basic study period (within 8 weeks): Fluoxetine monotherapy; The control group was treated with Shuganjieyu capsule simulator (2 capsules each time, twice a day) + Fluoxetine (20 mg, once a day). After 2 weeks of treatment, the reduction rate of HAMD-17 total scores was less than 20 %. The dosage of Shuganjieyu capsule simulator was adjusted to 4 capsules each time, twice a day. (2) Medication in the expanded study period (After 8 weeks): if the reduction rate of HAMD-17 total scores is below 50 %, the control group will be treated with Shuganjieyu capsule (2 capsules each time, twice a day), and then the dosage of Fluoxetine will be adjusted to 40 mg / time, once a day. Receives: Drug: Fluoxetine; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: Day 0 to Day 56

Secondary outcomes (8)

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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Day 0 to Day 56

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

19 May 202229 May 2024

First posted4 May 2022
Study start19 May 2022
Primary completion29 May 2024
Study completion29 May 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Outpatients / Inpatients With DepressionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 160 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05361330
Sponsor's protocol ID: V2.0
Status last verified: Sep 2026
First submitted: 20 Apr 2022
Last updated: 16 Sep 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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