Evaluation of Efficacy of Lycium Barbarum Polysaccharide in Patients With Major Depressive Disorder

Depression Clinical Trial

Official title:

Evaluation of Efficacy of Lycium Barbarum Polysaccharide in Patients With Major Depressive Disorder: a Randomized,Placebo-controled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04124276
• Other study ID #: Guangzhou Brain LBPMD
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2019
• Est. completion date: June 1, 2021

Study information

• Verified date: October 2020
• Source: Guangzhou Psychiatric Hospital
• Contact: Kangguang Lin, MD, PhD
• Phone: 13560360144
• Email: klin[@]connect.hku.hk
• 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 patients with major depressive disorder (MDD). The purpose of this clinical trial is to investigate the efficacy of LBP in patients with MDD.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 284
• Est. completion date: June 1, 2021
• Est. primary completion date: December 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

1. Age: 18-60 years old

2. Sex: both men and women

3. Compliance with the Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) diagnostic criteria for major depressive disorder

4. Hamilton Depression Scale scored more than 18 points.

5. No contraindication of taking Lycium barbarum polysaccharide

Exclusion Criteria:

1. Comorbidity with other mental disorders

2. Severe somatic diseases

3. Current use of traditional Chinese medicine

4. Suicide concept, attempt, act and attempted suicide

5. Psychiatric symptoms

6. Taking hormones and endocrine drugs

7. Long-term use of wolfberry in recent three months

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Disease
• Major Depressive Disorder

Intervention

Dietary Supplement:
• Lycium barbarum polysaccharide
Experimental groups take Lycium barbarum polysaccharide (LBP) (300mg/day) for 6 weeks
• Placebo
Placebo control group takes placebo (300mg/day) for 6 weeks.

Locations

Country	Name	City	State
China	Guangzhou Brain Hospital (Guangzhou Huiai Hospital)	Guanzhou	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
Primary	Reduction rate of Hamilton Depression Scale (HDRS)	HDRS is used to measure the depressive severity;its measured time range is within the past week. In this study, version of 24-items is used. The patients are depressed when the total score are greater than 19 points, and there are no depression when the total scores are less than points. Clinical control, HDRS score reduction rate=75%; significant progress, 50%=HDRS score reduction rate < 75%; progress, 25%=HDRS score reduction rate < 50%; ineffectiveness, HDRS score reduction rate < 25%. significant efficiency = (clinical control + significant progress) / sample number×100%.	4weeks, 6weeks
Secondary	Changes in depressive severity measured by Beck Depression Inventory (BDI) scale and Kessler Scale(K10)	BDI scale is used to measure depressive severity by patients themselves. It's made of 21 items. Circle the number in front of the sentence that best suits your situation in according to the feeling for a week. The total score is obtained by adding up the delimited scores of each item. There is depression when the total score is greater than 15 points and there is no depression when the total score is less than 10 points. The K10 is a widely used, simple self-report measure of psychological distress which can be used to identify those in need of further assessment of depression and anxiety	4 weeks, 6 weeks
Secondary	Changes in sleep quality	Changes in Pittsburgh Sleep Quality Index (PSQI) scale. PSQI scale is used to evaluate sleep quality for last month. It's made of 7 items; every item is scored 1-4 point. Total score is obtained by adding up the points of 7 items. Total score range is 0~21 point. The sleep quality is worse when the total score is higher.	4 weeks, 6 weeks
Secondary	Changes in cognitive function	Cognitive function is assessed using the THINC-it. The THINC-it was recently developed by the THINC-it Task Force (http://thinc.progress.im/en) with the principal goal of time-efficient screening of cognitive impairments specifically among individuals with major depressive disorder as a routine component of their clinical care. THINC-it is a digitized cognitive assessment battery comprised of carefully selected gamified variations of well-known cognitive tasks (Spotter [Choice Reaction Time], Symbol Check [One-Back], Codebreaker [Digit Symbol Substitution Test], Trails [Trail Making Test-Part B]), and the Perceived Deficits Questionnaire for Depression-5-item (PDQ-5-D), a subjective self-report scale.	4 weeks, 6 weeks
Secondary	Changes in social adaptive levels	Measured by Global Assessment Function (GAF) scale. GAF scale is used to evaluate the condition and social adaptability in psychiatry patients. It's divided into 1 to 100 grades. The lower the score, the more serious the disease is. 91-100 points shows that the patients have good social adaptation and normal mental status.	4 weeks, 6 weeks
Secondary	Changes in serum brain-derived neurotrophic factor (BDNF) levels	We measure the serum BDNF levels by enzyme linked immunosorbent assay (ELISA)	6 weeks
Secondary	Changes in serum triglyceride levels	The blood of patients are sent to clinical laboratory of our hospital to measure serum triglyceride levels	6 weeks
Secondary	Changes in serum total cholesterol levels	The blood of patients are sent to clinical laboratory of our hospital to measure serum total cholesterol levels	6 weeks