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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
172
Experimental group takes Lycium barbarum polysaccharide (LBP) tablet (300mg/day)for 6 weeks
Placebo-controlled group take he placebo capsules that are identical in shape, color, and taste to LBP tablet.
The Affiliated Fifth Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
RECRUITINGMean 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).
Time frame: 6 weeks
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.
Time frame: 4 and 6 weeks
Changes in sleep quality
Changes in Pittsburgh Sleep Quality Index (PSQI)
Time frame: 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.
Time frame: 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.
Time frame: 6 week
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