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

Overview

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.

Full Title of Study: “Evaluation of Efficacy of Lycium Barbarum Polysaccharide in People With Subthreshold Depression: a Randomized, Placebo-controlled Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: September 30, 2020

Interventions

  • Dietary Supplement: Lycium barbarum polysaccharide
    • Experimental group takes Lycium barbarum polysaccharide (LBP) tablet (300mg/day)for 6 weeks
  • Dietary Supplement: Placebo
    • Placebo-controlled group take he placebo capsules that are identical in shape, color, and taste to LBP tablet.

Arms, Groups and Cohorts

  • Experimental: Lycium barbarum polysaccharide (LBP)
    • Experimental group takes 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.

Clinical Trial Outcome Measures

Primary Measures

  • Percentage of Subjects Who Met Criteria for Remission Based on Beck Depression Inventory-II (BDI-2)
    • Time Frame: 6 weeks
    • 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.

Secondary Measures

  • Changes in The Screen for Child Anxiety Related Disorders (SCARED)
    • Time Frame: 4 and 6 weeks
    • 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
    • Time Frame: 6 weeks
    • Changes in Pittsburgh Sleep Quality Index (PSQI)
  • Depression severity as measured by BDI2 and Kessler Scale (K10)
    • Time Frame: 6 weeks
    • 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.

Participating in This Clinical Trial

Inclusion Criteria

1. BDI2 scores greater than or equal to 10

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, 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

Gender Eligibility: All

Minimum Age: 12 Years

Maximum Age: 18 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Guangzhou Psychiatric Hospital
  • Collaborator
    • The Fifth Affiliated Hospital of Guangzhou Medical University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Kangguang Lin, Deputy director, Department of Affective disorders – Guangzhou Psychiatric Hospital
  • Overall Official(s)
    • Kwok-Fai So, PhD, Study Chair, Guangzhou Medical University
    • Kangguang Lin, MD,PhD, Study Director, Guangzhou Brain Hospital (Guangzhou Huiai Hospital);The fifth affiliated hospital of Guangzhou Medical University
    • Xuan Mo, MD, Principal Investigator, The Fifth Affiliated Hospital of Guangzhou Medical University
    • Guiyun Xu, MD, Principal Investigator, Guangzhou Brain Hospital (Guangzhou Huiai Hospital)
  • Overall Contact(s)
    • Kangguang Lin, MD, 8613560360144, linkangguang@163.com

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