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

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ClinicalTrials.gov Identifier: NCT04032795
Recruitment Status : Not yet recruiting
First Posted : July 25, 2019
Last Update Posted : July 25, 2019
Sponsor:
Collaborator:
The Fifth Affiliated Hospital of Guangzhou Medical University
Information provided by (Responsible Party):
Kangguang Lin, Guangzhou Psychiatric Hospital

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.

Condition or disease Intervention/treatment Phase
Subthreshold Depression Depressive Symptoms Anxious Symptoms Dietary Supplement: Lycium barbarum polysaccharide Dietary Supplement: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 172 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of Efficacy of Lycium Barbarum Polysaccharide in People With Subthreshold Depression: a Randomized, Placebo-controlled Trial
Estimated Study Start Date : August 5, 2019
Estimated Primary Completion Date : July 30, 2020
Estimated Study Completion Date : October 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Lycium barbarum polysaccharide (LBP)
Experimental group takes LBP tablet (400mg/day) for 6 weeks
Dietary Supplement: Lycium barbarum polysaccharide
Experimental group takes Lycium barbarum polysaccharide (LBP) tablet (400mg/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.




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

  2. Changes in sleep quality [ Time Frame: 6 weeks ]
    Changes in Pittsburgh Sleep Quality Index (PSQI)

  3. 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.


Other Outcome Measures:
  1. Treatment-emergent symptom side effect (TESS) scale. [ Time Frame: 4 and 6 weeks ]
    Side effect was evaluated by treatment-emergent symptom side effect (TESS) scale.



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Ages Eligible for Study:   12 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04032795


Contacts
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Contact: Kangguang Lin, MD 8613560360144 linkangguang@163.com
Contact: Xuan Mo, MD 8615622326389 mx7628@126.com

Sponsors and Collaborators
Guangzhou Psychiatric Hospital
The Fifth Affiliated Hospital of Guangzhou Medical University
Investigators
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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 The Fifth Affiliated Hospital of Guangzhou Medical University
Principal Investigator: Guiyun Xu, MD Guangzhou Brain Hospital (Guangzhou Huiai Hospital)

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Responsible Party: Kangguang Lin, Deputy director, Department of Affective disorders, Guangzhou Psychiatric Hospital
ClinicalTrials.gov Identifier: NCT04032795     History of Changes
Other Study ID Numbers: Guangzhou Brain LBP
First Posted: July 25, 2019    Key Record Dates
Last Update Posted: July 25, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kangguang Lin, Guangzhou Psychiatric Hospital:
Major Depressive Disorder
Lycium barbarum polysaccharide
depressive symptoms
anxious symptoms
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders