Evaluation of Efficacy of Lycium Barbarum Polysaccharide in People With Subthreshold Depression

Evaluation of Efficacy of Lycium Barbarum Polysaccharide in People With Subthreshold Depression: a Randomized, Placebo-controlled Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Depressive Symptoms; Anxious Symptoms; Subthreshold Depression
• Intervention / Treatment: Dietary supplement: Lycium barbarum polysaccharide; Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Anticipated): 172
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kangguang Lin, MD; Phone Number: 8613560360144; Email: linkangguang@163.com
• Study Contact Backup: Name: Xuan Mo, MD; Phone Number: 8615622326389; Email: mx7628@126.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China
      • Recruiting
      • The Affiliated Fifth Hospital of Guangzhou Medical University
      • Contact: Xuan Mo, M.D

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 18 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. 15-25 scores in the Beck Depression Rating Scale (BDI- II)
2. There is no contraindication of taking LBP.

Exclusion Criteria:

1. Current treatment for a mental health problem from a mental health professional
2. Current and lifetime history of psychiatric disorders (e.g major depressive disorder, as ascertained by CIDI
3. Systemic disease requiring regular medication.
4. There are suicidal ideation, suicidal attempt, suicide behavior and attempted suicide.
5. Dislike of or allergy to goji berry
6. Hormone or Endocrine therapeutic drugs are being taken.
7. Long-term use of lycium chinensis in recent three months

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Lycium barbarum polysaccharide (LBP); Experimental group takes LBP tablet (300mg/day) for 6 weeks	Dietary supplement: Lycium barbarum polysaccharide; Experimental group takes Lycium barbarum polysaccharide (LBP) tablet (300mg/day)for 6 weeks
PLACEBO_COMPARATOR: Placebo; Placebo control group takes placebo 6 weeks. The placebos are the same with the LBP tablets in appearance and taste.	Dietary supplement: Placebo; Placebo-controlled group take he placebo capsules that are identical in shape, color, and taste to LBP tablet.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	4 and 6 weeks
Changes in sleep quality	Changes in Pittsburgh Sleep Quality Index (PSQI)	6 weeks
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.	6 weeks
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.	6 week

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment-emergent symptom side effect (TESS) scale.	Side effect was evaluated by treatment-emergent symptom side effect (TESS) scale.	4 and 6 weeks

Collaborators and Investigators

• Sponsor: Guangzhou Psychiatric Hospital
• Collaborators: Fifth Affiliated Hospital of Guangzhou Medical University
• Investigators: Study Chair: Kwok-Fai So, PhD, Guangzhou Medical University; Study Director: Kangguang Lin, MD,PhD, Guangzhou Brain Hospital (Guangzhou Huiai Hospital);The fifth affiliated hospital of Guangzhou Medical University; Principal Investigator: Xuan Mo, MD, Fifth Affiliated Hospital of Guangzhou Medical University; Principal Investigator: Guiyun Xu, MD, Guangzhou Brain Hospital (Guangzhou Huiai Hospital)

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 15, 2019
• Primary Completion (ANTICIPATED): December 30, 2021
• Study Completion (ANTICIPATED): December 30, 2021

Study Registration Dates

• First Submitted: July 19, 2019
• First Submitted That Met QC Criteria: July 24, 2019
• First Posted (ACTUAL): July 25, 2019

Study Record Updates

• Last Update Posted (ACTUAL): November 19, 2021
• Last Update Submitted That Met QC Criteria: November 11, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: Major Depressive Disorder; depressive symptoms; Lycium barbarum polysaccharide; anxious symptoms
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder
• Other Study ID Numbers: Guangzhou Brain LBP

Drug and device information, study documents

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