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

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

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.

Study Overview

• Status: Unknown
• Conditions: Depressive Disorder; Depression; Major Depressive Disorder
• Intervention / Treatment: Dietary supplement: Lycium barbarum polysaccharide; Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Anticipated): 284
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guanzhou, Guangdong, China, 510370
      • Recruiting
      • Guangzhou Brain Hospital (Guangzhou Huiai Hospital)
      • Contact: Kangguang Lin, MD，PhD; Phone Number: 13560360144; Email: klin@connect.hku.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lycium barbarum polysaccharide; Experimental group takes Lycium barbarum polysaccharide (LBP) tablet (300mg/day) for 6 weeks	Dietary supplement: Lycium barbarum polysaccharide; Experimental groups take Lycium barbarum polysaccharide (LBP) (300mg/day) for 6 weeks
Placebo Comparator: Placebo; Placebo control group takes placebo (300mg/day) for 6 weeks. The placebos are the same with the LBP tablets in appearance and taste.	Dietary supplement: Placebo; Placebo control group takes placebo (300mg/day) for 6 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
Changes in serum brain-derived neurotrophic factor (BDNF) levels	We measure the serum BDNF levels by enzyme linked immunosorbent assay (ELISA)	6 weeks
Changes in serum triglyceride levels	The blood of patients are sent to clinical laboratory of our hospital to measure serum triglyceride levels	6 weeks
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

Collaborators and Investigators

• Sponsor: Guangzhou Psychiatric Hospital
• Collaborators: Fifth Affiliated Hospital of Guangzhou Medical University
• Investigators: Principal Investigator: Kangguang Lin, MD, PhD, Guangzhou Brain Hospital (Guangzhou Huiai Hospital)

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2019
• Primary Completion (Anticipated): December 30, 2020
• Study Completion (Anticipated): June 1, 2021

Study Registration Dates

• First Submitted: October 5, 2019
• First Submitted That Met QC Criteria: October 10, 2019
• First Posted (Actual): October 11, 2019

Study Record Updates

• Last Update Posted (Actual): October 30, 2020
• Last Update Submitted That Met QC Criteria: October 28, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: Major Depressive Disorder; Lycium barbarum polysaccharide
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Pathologic Processes; Mood Disorders; Depression; Depressive Disorder; Disease; Depressive Disorder, Major
• Other Study ID Numbers: Guangzhou Brain LBPMD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No