Back to resultsEvaluation of Efficacy of Lycium Barbarum Polysaccharide in People With Subthreshold Depression
Primary Purpose
Subthreshold Depression, Depressive Symptoms, Anxious Symptoms
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Lycium barbarum polysaccharide
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Subthreshold Depression focused on measuring Major Depressive Disorder, Lycium barbarum polysaccharide, depressive symptoms, anxious symptoms
Eligibility Criteria
Inclusion Criteria:
- 15-25 scores in the Beck Depression Rating Scale (BDI- II)
- There is no contraindication of taking LBP.
Exclusion Criteria:
- Current treatment for a mental health problem from a mental health professional
- Current and lifetime history of psychiatric disorders (e.g major depressive disorder, as ascertained by CIDI
- Systemic disease requiring regular medication.
- There are suicidal ideation, suicidal attempt, suicide behavior and attempted suicide.
- Dislike of or allergy to goji berry
- Hormone or Endocrine therapeutic drugs are being taken.
- Long-term use of lycium chinensis in recent three months
Sites / Locations
- The Affiliated Fifth Hospital of Guangzhou Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Lycium barbarum polysaccharide (LBP)
Placebo
Arm Description
Experimental group takes LBP tablet (300mg/day) for 6 weeks
Placebo control group takes placebo 6 weeks. The placebos are the same with the LBP tablets in appearance and taste.
Outcomes
Primary Outcome Measures
Mean changes from baseline in the 21-item Hamilton Depression Rating Scale (24-HAMD)
The 24-item HAM-D scale is widely used to assess the severity of depression.The scale is a 21-item assessment used to measure depression severity. Items were rated on a scale from 0 (symptoms not present) to a maximum of 2 to 4 (symptom extremely severe) for a total score ranging from 0 (not at all depressed) to 64 (severely depressed).
Secondary Outcome Measures
Changes in The Screen for Child Anxiety Related Disorders (SCARED)
The SCARED is a child and parent self-report instrument used to screen for childhood anxiety disorders including general anxiety disorder, separation anxiety disorder, panic disorder, and social phobia.
Changes in sleep quality
Changes in Pittsburgh Sleep Quality Index (PSQI)
Depression severity as measured by BDI2 and Kessler Scale (K10)
The Kessler psychological distress scale (K10) is a widely used, simple self-report measure of psychological distress which can be used to identify those in need of further assessment for anxiety and depression.
Mean change from baseline in the Beck Depression Inventory-II (BDI-2)total scores
The BDI-II is a 21-item self-report measure of depressive symptom.Remission was defined as equal or less than 8 scores on BDI-2.
Full Information
NCT ID
NCT04032795
First Posted
July 19, 2019
Last Updated
November 11, 2021
Sponsor
Guangzhou Psychiatric Hospital
Collaborators
Fifth Affiliated Hospital of Guangzhou Medical University
1. Study Identification
Unique Protocol Identification Number
NCT04032795
Brief Title
Evaluation of Efficacy of Lycium Barbarum Polysaccharide in People With Subthreshold Depression
Official Title
Evaluation of Efficacy of Lycium Barbarum Polysaccharide in People With Subthreshold Depression: a Randomized, Placebo-controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Recruiting
Study Start Date
May 15, 2019 (Actual)
Primary Completion Date
December 30, 2021 (Anticipated)
Study Completion Date
December 30, 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 people with subthreshold depression.The purpose of this clinical trial is to investigate the efficacy of LBP in people with subthreshold depression.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Subthreshold Depression, Depressive Symptoms, Anxious Symptoms
Keywords
Major Depressive Disorder, Lycium barbarum polysaccharide, depressive symptoms, anxious symptoms
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
172 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Lycium barbarum polysaccharide (LBP)
Arm Type
Experimental
Arm Description
Experimental group takes LBP tablet (300mg/day) for 6 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo control group takes placebo 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 group takes Lycium barbarum polysaccharide (LBP) tablet (300mg/day)for 6 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Placebo-controlled group take he placebo capsules that are identical in shape, color, and taste to LBP tablet.
Primary Outcome Measure Information:
Title
Mean changes from baseline in the 21-item Hamilton Depression Rating Scale (24-HAMD)
Description
The 24-item HAM-D scale is widely used to assess the severity of depression.The scale is a 21-item assessment used to measure depression severity. Items were rated on a scale from 0 (symptoms not present) to a maximum of 2 to 4 (symptom extremely severe) for a total score ranging from 0 (not at all depressed) to 64 (severely depressed).
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Changes in The Screen for Child Anxiety Related Disorders (SCARED)
Description
The SCARED is a child and parent self-report instrument used to screen for childhood anxiety disorders including general anxiety disorder, separation anxiety disorder, panic disorder, and social phobia.
Time Frame
4 and 6 weeks
Title
Changes in sleep quality
Description
Changes in Pittsburgh Sleep Quality Index (PSQI)
Time Frame
6 weeks
Title
Depression severity as measured by BDI2 and Kessler Scale (K10)
Description
The Kessler psychological distress scale (K10) is a widely used, simple self-report measure of psychological distress which can be used to identify those in need of further assessment for anxiety and depression.
Time Frame
6 weeks
Title
Mean change from baseline in the Beck Depression Inventory-II (BDI-2)total scores
Description
The BDI-II is a 21-item self-report measure of depressive symptom.Remission was defined as equal or less than 8 scores on BDI-2.
Time Frame
6 week
Other Pre-specified Outcome Measures:
Title
Treatment-emergent symptom side effect (TESS) scale.
Description
Side effect was evaluated by treatment-emergent symptom side effect (TESS) scale.
Time Frame
4 and 6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
15-25 scores in the Beck Depression Rating Scale (BDI- II)
There is no contraindication of taking LBP.
Exclusion Criteria:
Current treatment for a mental health problem from a mental health professional
Current and lifetime history of psychiatric disorders (e.g major depressive disorder, as ascertained by CIDI
Systemic disease requiring regular medication.
There are suicidal ideation, suicidal attempt, suicide behavior and attempted suicide.
Dislike of or allergy to goji berry
Hormone or Endocrine therapeutic drugs are being taken.
Long-term use of lycium chinensis in recent three months
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kangguang Lin, MD
Phone
8613560360144
Email
linkangguang@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Xuan Mo, MD
Phone
8615622326389
Email
mx7628@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kwok-Fai So, PhD
Organizational Affiliation
Guangzhou Medical University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Kangguang Lin, MD,PhD
Organizational Affiliation
Guangzhou Brain Hospital (Guangzhou Huiai Hospital);The fifth affiliated hospital of Guangzhou Medical University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Xuan Mo, MD
Organizational Affiliation
Fifth Affiliated Hospital of Guangzhou Medical University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Guiyun Xu, MD
Organizational Affiliation
Guangzhou Brain Hospital (Guangzhou Huiai Hospital)
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Affiliated Fifth Hospital of Guangzhou Medical University
City
Guangzhou
State/Province
Guangdong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xuan Mo, M.D
12. IPD Sharing Statement
Citations:
PubMed Identifier
34916444
Citation
Li X, Mo X, Liu T, Shao R, Teopiz K, McIntyre RS, So KF, Lin K. Efficacy of Lycium barbarum polysaccharide in adolescents with subthreshold depression: interim analysis of a randomized controlled study. Neural Regen Res. 2022 Jul;17(7):1582-1587. doi: 10.4103/1673-5374.330618.
Results Reference
derived
Learn more about this trial
Evaluation of Efficacy of Lycium Barbarum Polysaccharide in People With Subthreshold Depression
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