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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04032795
Other study ID # Guangzhou Brain LBP
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 15, 2019
Est. completion date December 30, 2021

Study information

Verified date November 2021
Source Guangzhou Psychiatric Hospital
Contact Kangguang Lin, MD
Phone 8613560360144
Email linkangguang@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 172
Est. completion date December 30, 2021
Est. primary completion date December 30, 2021
Accepts healthy volunteers No
Gender All
Age group 12 Years to 18 Years
Eligibility 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 Design


Intervention

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

Locations

Country Name City State
China The Affiliated Fifth Hospital of Guangzhou Medical University Guangzhou Guangdong

Sponsors (2)

Lead Sponsor Collaborator
Guangzhou Psychiatric Hospital The Fifth Affiliated Hospital of Guangzhou Medical University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Other Treatment-emergent symptom side effect (TESS) scale. Side effect was evaluated by treatment-emergent symptom side effect (TESS) scale. 4 and 6 weeks
Primary 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 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
Secondary Changes in sleep quality Changes in Pittsburgh Sleep Quality Index (PSQI) 6 weeks
Secondary 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
Secondary 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
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