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Evaluation of Efficacy of Lycium Barbarum Polysaccharide in Patients With Major Depressive Disorder

Primary Purpose

Major Depressive Disorder, Depression, Depressive Disorder

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Lycium barbarum polysaccharide
Placebo
Sponsored by
Guangzhou Psychiatric Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring Major Depressive Disorder, Lycium barbarum polysaccharide

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age: 18-60 years old
  2. Sex: both men and women
  3. Compliance with the Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) diagnostic criteria for major depressive disorder
  4. Hamilton Depression Scale scored more than 18 points.
  5. No contraindication of taking Lycium barbarum polysaccharide

Exclusion Criteria:

  1. Comorbidity with other mental disorders
  2. Severe somatic diseases
  3. Current use of traditional Chinese medicine
  4. Suicide concept, attempt, act and attempted suicide
  5. Psychiatric symptoms
  6. Taking hormones and endocrine drugs
  7. Long-term use of wolfberry in recent three months

Sites / Locations

  • Guangzhou Brain Hospital (Guangzhou Huiai Hospital)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Lycium barbarum polysaccharide

Placebo

Arm Description

Experimental group takes Lycium barbarum polysaccharide (LBP) tablet (300mg/day) for 6 weeks

Placebo control group takes placebo (300mg/day) for 6 weeks. The placebos are the same with the LBP tablets in appearance and taste.

Outcomes

Primary Outcome Measures

Reduction rate of Hamilton Depression Scale (HDRS)
HDRS is used to measure the depressive severity；its measured time range is within the past week. In this study, version of 24-items is used. The patients are depressed when the total score are greater than 19 points, and there are no depression when the total scores are less than points. Clinical control, HDRS score reduction rate≥75%; significant progress, 50%≤HDRS score reduction rate < 75%; progress, 25%≤HDRS score reduction rate < 50%; ineffectiveness, HDRS score reduction rate < 25%. significant efficiency = (clinical control + significant progress) / sample number×100%.

Secondary Outcome Measures

Changes in depressive severity measured by Beck Depression Inventory (BDI) scale and Kessler Scale(K10)
BDI scale is used to measure depressive severity by patients themselves. It's made of 21 items. Circle the number in front of the sentence that best suits your situation in according to the feeling for a week. The total score is obtained by adding up the delimited scores of each item. There is depression when the total score is greater than 15 points and there is no depression when the total score is less than 10 points. The K10 is a widely used, simple self-report measure of psychological distress which can be used to identify those in need of further assessment of depression and anxiety
Changes in sleep quality
Changes in Pittsburgh Sleep Quality Index (PSQI) scale. PSQI scale is used to evaluate sleep quality for last month. It's made of 7 items; every item is scored 1-4 point. Total score is obtained by adding up the points of 7 items. Total score range is 0~21 point. The sleep quality is worse when the total score is higher.
Changes in cognitive function
Cognitive function is assessed using the THINC-it. The THINC-it was recently developed by the THINC-it Task Force (http://thinc.progress.im/en) with the principal goal of time-efficient screening of cognitive impairments specifically among individuals with major depressive disorder as a routine component of their clinical care. THINC-it is a digitized cognitive assessment battery comprised of carefully selected gamified variations of well-known cognitive tasks (Spotter [Choice Reaction Time], Symbol Check [One-Back], Codebreaker [Digit Symbol Substitution Test], Trails [Trail Making Test-Part B]), and the Perceived Deficits Questionnaire for Depression-5-item (PDQ-5-D), a subjective self-report scale.
Changes in social adaptive levels
Measured by Global Assessment Function (GAF) scale. GAF scale is used to evaluate the condition and social adaptability in psychiatry patients. It's divided into 1 to 100 grades. The lower the score, the more serious the disease is. 91-100 points shows that the patients have good social adaptation and normal mental status.
Changes in serum brain-derived neurotrophic factor (BDNF) levels
We measure the serum BDNF levels by enzyme linked immunosorbent assay (ELISA)
Changes in serum triglyceride levels
The blood of patients are sent to clinical laboratory of our hospital to measure serum triglyceride levels
Changes in serum total cholesterol levels
The blood of patients are sent to clinical laboratory of our hospital to measure serum total cholesterol levels

Full Information

First Posted
October 5, 2019
Last Updated
October 28, 2020
Sponsor
Guangzhou Psychiatric Hospital
Collaborators
Fifth Affiliated Hospital of Guangzhou Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT04124276
Brief Title
Evaluation of Efficacy of Lycium Barbarum Polysaccharide in Patients With Major Depressive Disorder
Official Title
Evaluation of Efficacy of Lycium Barbarum Polysaccharide in Patients With Major Depressive Disorder: a Randomized,Placebo-controled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
November 1, 2019 (Actual)
Primary Completion Date
December 30, 2020 (Anticipated)
Study Completion Date
June 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guangzhou Psychiatric Hospital
Collaborators
Fifth Affiliated Hospital of Guangzhou Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Lycium barbarum, a traditional Chinese herbal medicine, is a commonly used herb in the traditional Chinese pharmacopoeia. Its main active ingredient, lycium barbarum polysaccharide (LBP), is reported to have neuroprotective effects. Animal studies suggested that LBP has neuroprotective effect on optic ganglion cells. In animal models of depression, LBP can improve depressive symptom by improving synaptic plasticity. However, its clinical effect remains to be studied. We will conduct a 6-week double-blind, randomized, placebo-con-trolled trial in patients with major depressive disorder (MDD). The purpose of this clinical trial is to investigate the efficacy of LBP in patients with MDD.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder, Depression, Depressive Disorder
Keywords
Major Depressive Disorder, Lycium barbarum polysaccharide

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
284 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Lycium barbarum polysaccharide
Arm Type
Experimental
Arm Description
Experimental group takes Lycium barbarum polysaccharide (LBP) tablet (300mg/day) for 6 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo control group takes placebo (300mg/day) for 6 weeks. The placebos are the same with the LBP tablets in appearance and taste.
Intervention Type
Dietary Supplement
Intervention Name(s)
Lycium barbarum polysaccharide
Intervention Description
Experimental groups take Lycium barbarum polysaccharide (LBP) (300mg/day) for 6 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Placebo control group takes placebo (300mg/day) for 6 weeks.
Primary Outcome Measure Information:
Title
Reduction rate of Hamilton Depression Scale (HDRS)
Description
HDRS is used to measure the depressive severity；its measured time range is within the past week. In this study, version of 24-items is used. The patients are depressed when the total score are greater than 19 points, and there are no depression when the total scores are less than points. Clinical control, HDRS score reduction rate≥75%; significant progress, 50%≤HDRS score reduction rate < 75%; progress, 25%≤HDRS score reduction rate < 50%; ineffectiveness, HDRS score reduction rate < 25%. significant efficiency = (clinical control + significant progress) / sample number×100%.
Time Frame
4weeks, 6weeks
Secondary Outcome Measure Information:
Title
Changes in depressive severity measured by Beck Depression Inventory (BDI) scale and Kessler Scale(K10)
Description
BDI scale is used to measure depressive severity by patients themselves. It's made of 21 items. Circle the number in front of the sentence that best suits your situation in according to the feeling for a week. The total score is obtained by adding up the delimited scores of each item. There is depression when the total score is greater than 15 points and there is no depression when the total score is less than 10 points. The K10 is a widely used, simple self-report measure of psychological distress which can be used to identify those in need of further assessment of depression and anxiety
Time Frame
4 weeks, 6 weeks
Title
Changes in sleep quality
Description
Changes in Pittsburgh Sleep Quality Index (PSQI) scale. PSQI scale is used to evaluate sleep quality for last month. It's made of 7 items; every item is scored 1-4 point. Total score is obtained by adding up the points of 7 items. Total score range is 0~21 point. The sleep quality is worse when the total score is higher.
Time Frame
4 weeks, 6 weeks
Title
Changes in cognitive function
Description
Cognitive function is assessed using the THINC-it. The THINC-it was recently developed by the THINC-it Task Force (http://thinc.progress.im/en) with the principal goal of time-efficient screening of cognitive impairments specifically among individuals with major depressive disorder as a routine component of their clinical care. THINC-it is a digitized cognitive assessment battery comprised of carefully selected gamified variations of well-known cognitive tasks (Spotter [Choice Reaction Time], Symbol Check [One-Back], Codebreaker [Digit Symbol Substitution Test], Trails [Trail Making Test-Part B]), and the Perceived Deficits Questionnaire for Depression-5-item (PDQ-5-D), a subjective self-report scale.
Time Frame
4 weeks, 6 weeks
Title
Changes in social adaptive levels
Description
Measured by Global Assessment Function (GAF) scale. GAF scale is used to evaluate the condition and social adaptability in psychiatry patients. It's divided into 1 to 100 grades. The lower the score, the more serious the disease is. 91-100 points shows that the patients have good social adaptation and normal mental status.
Time Frame
4 weeks, 6 weeks
Title
Changes in serum brain-derived neurotrophic factor (BDNF) levels
Description
We measure the serum BDNF levels by enzyme linked immunosorbent assay (ELISA)
Time Frame
6 weeks
Title
Changes in serum triglyceride levels
Description
The blood of patients are sent to clinical laboratory of our hospital to measure serum triglyceride levels
Time Frame
6 weeks
Title
Changes in serum total cholesterol levels
Description
The blood of patients are sent to clinical laboratory of our hospital to measure serum total cholesterol levels
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age: 18-60 years old Sex: both men and women Compliance with the Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) diagnostic criteria for major depressive disorder Hamilton Depression Scale scored more than 18 points. No contraindication of taking Lycium barbarum polysaccharide Exclusion Criteria: Comorbidity with other mental disorders Severe somatic diseases Current use of traditional Chinese medicine Suicide concept, attempt, act and attempted suicide Psychiatric symptoms Taking hormones and endocrine drugs Long-term use of wolfberry in recent three months
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kangguang Lin, MD, PhD
Phone
13560360144
Email
klin@connect.hku.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kangguang Lin, MD, PhD
Organizational Affiliation
Guangzhou Brain Hospital (Guangzhou Huiai Hospital)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Guangzhou Brain Hospital (Guangzhou Huiai Hospital)
City
Guanzhou
State/Province
Guangdong
ZIP/Postal Code
510370
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kangguang Lin, MD，PhD
Phone
13560360144
Email
klin@connect.hku.hk

12. IPD Sharing Statement

Learn more about this trial

Evaluation of Efficacy of Lycium Barbarum Polysaccharide in Patients With Major Depressive Disorder

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