Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04124276
Recruitment Status : Not yet recruiting
First Posted : October 11, 2019
Last Update Posted : October 11, 2019
Sponsor:
Collaborator:
The Fifth Affiliated Hospital of Guangzhou Medical University
Information provided by (Responsible Party):
Kangguang Lin, Guangzhou Psychiatric Hospital

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 Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : November 1, 2019
Estimated Primary Completion Date : July 30, 2020
Estimated Study Completion Date : October 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Lycium barbarum polysaccharide
Experimental group takes Lycium barbarum polysaccharide (LBP) tablet (400mg/day) for 6 weeks
Dietary Supplement: Lycium barbarum polysaccharide
Experimental groups take Lycium barbarum polysaccharide (LBP) (400mg/day) for 6 weeks

Placebo Comparator: Placebo
Placebo control group takes placebo (400mg/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 (400mg/day) for 6 weeks.




Primary Outcome Measures :
  1. Reduction rate of Hamilton Depression Scale (HDRS) [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 6 weeks ]
    We measure the serum BDNF levels by enzyme linked immunosorbent assay (ELISA)

  6. Changes in serum triglyceride levels [ Time Frame: 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 [ Time Frame: 6 weeks ]
    The blood of patients are sent to clinical laboratory of our hospital to measure serum total cholesterol levels



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04124276


Contacts
Layout table for location contacts
Contact: Kangguang Lin, MD, PhD 13560360144 klin@connect.hku.hk

Locations
Layout table for location information
China, Guangdong
Guangzhou Brain Hospital (Guangzhou Huiai Hospital) Not yet recruiting
Guanzhou, Guangdong, China, 510370
Contact: Kangguang Lin, MD,PhD    13560360144    klin@connect.hku.hk   
Sponsors and Collaborators
Guangzhou Psychiatric Hospital
The Fifth Affiliated Hospital of Guangzhou Medical University
Investigators
Layout table for investigator information
Principal Investigator: Kangguang Lin, MD, PhD Guangzhou Brain Hospital (Guangzhou Huiai Hospital)

Layout table for additonal information
Responsible Party: Kangguang Lin, Deputy director, Department of Affective Disorder, Guangzhou Psychiatric Hospital
ClinicalTrials.gov Identifier: NCT04124276     History of Changes
Other Study ID Numbers: Guangzhou Brain LBPMD
First Posted: October 11, 2019    Key Record Dates
Last Update Posted: October 11, 2019
Last Verified: October 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kangguang Lin, Guangzhou Psychiatric Hospital:
Major Depressive Disorder
Lycium barbarum polysaccharide
Additional relevant MeSH terms:
Layout table for MeSH terms
Disease
Depression
Depressive Disorder
Depressive Disorder, Major
Pathologic Processes
Behavioral Symptoms
Mood Disorders
Mental Disorders