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

Depressive Symptoms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04032795
• Other study ID #: Guangzhou Brain LBP
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Anxious Symptoms
• Depression
• Depressive Disorder
• Depressive Symptoms
• Subthreshold Depression

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