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

• Sponsor: Guangzhou Psychiatric Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04124276
• Collaborator: The Fifth Affiliated Hospital of Guangzhou Medical University (Other)
• Enrollment: 284
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 19
• Patients Per Site Per Month: 15

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Major Depressive Disorder; Depression; Depressive Disorder	Dietary Supplement: Lycium barbarum polysaccharide; Dietary Supplement: Placebo	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 284 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Evaluation of Efficacy of Lycium Barbarum Polysaccharide in Patients With Major Depressive Disorder: a Randomized,Placebo-controled Trial
• Actual Study Start Date: Nov 1, 2019
• Anticipated Primary Completion Date: Dec 30, 2020
• Anticipated Study Completion Date: Jun 1, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Reduction rate of Hamilton Depression Scale (HDRS) [4weeks, 6weeks]

   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%.

Secondary Outcome Measures

1. Changes in depressive severity measured by Beck Depression Inventory (BDI) scale and Kessler Scale(K10) [4 weeks, 6 weeks]

   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

2. Changes in sleep quality [4 weeks, 6 weeks]

   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.

3. Changes in cognitive function [4 weeks, 6 weeks]

   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. Changes in social adaptive levels [4 weeks, 6 weeks]

   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.

5. Changes in serum brain-derived neurotrophic factor (BDNF) levels [6 weeks]

   We measure the serum BDNF levels by enzyme linked immunosorbent assay (ELISA)

6. Changes in serum triglyceride levels [6 weeks]

   The blood of patients are sent to clinical laboratory of our hospital to measure serum triglyceride levels

7. Changes in serum total cholesterol levels [6 weeks]

   The blood of patients are sent to clinical laboratory of our hospital to measure serum total cholesterol levels

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Guangzhou Brain Hospital (Guangzhou Huiai Hospital)	Guanzhou	Guangdong	China	510370

Sponsors and Collaborators

• Guangzhou Psychiatric Hospital
• The Fifth Affiliated Hospital of Guangzhou Medical University

Investigators

• Principal Investigator: Kangguang Lin, MD, PhD, Guangzhou Brain Hospital (Guangzhou Huiai Hospital)

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Kangguang Lin, Deputy director, Department of Affective Disorder, Guangzhou Psychiatric Hospital
• ClinicalTrials.gov Identifier: NCT04124276
• Other Study ID Numbers: Guangzhou Brain LBPMD
• First Posted: Oct 11, 2019
• Last Update Posted: Oct 30, 2020
• Last Verified: Oct 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Kangguang Lin, Deputy director, Department of Affective Disorder, Guangzhou Psychiatric Hospital: Major Depressive Disorder; Lycium barbarum polysaccharide
• Additional relevant MeSH terms: Disease; Depression; Depressive Disorder; Depressive Disorder, Major

Study Results

No Results Posted as of Oct 30, 2020