NCT05361330

Brief 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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2022

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 20, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 4, 2022

Completed
26 days until next milestone

Study Start

First participant enrolled

May 30, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2023

Completed
Last Updated

May 17, 2022

Status Verified

May 1, 2022

Enrollment Period

11 months

First QC Date

April 20, 2022

Last Update Submit

May 15, 2022

Conditions

Outpatients / Inpatients With Depression

Keywords

Shuganjieyu capsuledepression

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • 17-item Hamilton depression rating scale (HAMD-17) total scores change at early time points

    Day 0 to Day 14, Day 0 to Day 28

  • Hamilton anxiety rating scale (HAMA) total score change

    Day 0 to Day 14, Day 0 to Day 28, Day 0 to Day 56

  • Patient Health Questionnaire-15 (PHQ-15) score change

    Day 0 to Day 14, Day 0 to Day 28, Day 0 to Day 56

  • Clinical Global Impression (CGI) score change

    Day 0 to Day 14, Day 0 to Day 28, Day 0 to Day 56

  • Pittsburgh Sleep Quality Index (PSQI) score change

    Day 0 to Day 14, Day 0 to Day 28, Day 0 to Day 56

  • +3 more secondary outcomes

Other Outcomes (9)

  • 17-item Hamilton depression rating scale (HAMD-17) change in the extended period

    Day 56 to Day 84, Day 56 to Day 112, Day 56 to Day 168

  • Relapse rate

    Day 56 to Day 84, Day 56 to Day 112, Day 56 to Day 168

  • the rate of changing medicines

    Day 56 to Day 168

  • +6 more other outcomes

Study Arms (2)

The experimental group: Shuganjieyu capsule

EXPERIMENTAL

Shuganjieyu capsule combined with Fluoxetine

Drug: Shuganjieyu capsuleDrug: Fluoxetine

The control group: Shuganjieyu capsule simulator

PLACEBO COMPARATOR

Fluoxetine monotherapy

Drug: Fluoxetine

Interventions

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

The experimental group: Shuganjieyu capsule
FluoxetineDRUG

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.

The control group: Shuganjieyu capsule simulatorThe experimental group: Shuganjieyu capsule

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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;
  • 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;
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Nanjing Brain Hospital, Nanjing Medical University

Nanjing, Jiangsu, 210000, China

Location

First Hospital, Shanxi Medical University

Taiyuan, Shanxi, 030000, China

Location

Institute of Mental Health, Peking University Sixth Hospital

Beijing, China

Location

MeSH Terms

Conditions

Depression

Interventions

Fluoxetine

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

PropylaminesAminesOrganic Chemicals

Central Study Contacts

Tianmei Si, PhD., MD.

CONTACT

861062723748sitianmei@bjmu.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vice President of Institute of Mental Health, Peking University Sixth Hospital, Director of Research Laboratory on Psychopharmacology of Institute of Mental Health, Peking University Sixth Hospital

Study Record Dates

First Submitted

April 20, 2022

First Posted

May 4, 2022

Study Start

May 30, 2022

Primary Completion

April 30, 2023

Study Completion

September 30, 2023

Last Updated

May 17, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations

CN(3)