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

Study Overview
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Brief Summary
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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.

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

Conditions
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Subthreshold Depression, Depressive Symptoms, Anxious Symptoms

Intervention / Treatment
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* Dietary Supplement: Lycium barbarum polysaccharide
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Major Depressive Disorder, Lycium barbarum polysaccharide, depressive symptoms, anxious symptoms