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

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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

Tracking Information
First Submitted Date  ICMJE October 5, 2019
First Posted Date  ICMJE October 11, 2019
Last Update Posted Date October 11, 2019
Estimated Study Start Date  ICMJE November 1, 2019
Estimated Primary Completion Date July 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 10, 2019)
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%.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: October 10, 2019)
  • 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
  • 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.
  • 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.
  • 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.
  • 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)
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of Efficacy of Lycium Barbarum Polysaccharide in Patients With Major Depressive Disorder
Official Title  ICMJE Evaluation of Efficacy of Lycium Barbarum Polysaccharide in Patients With Major Depressive Disorder: a Randomized,Placebo-controled Trial
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Major Depressive Disorder
  • Depression
  • Depressive Disorder
Intervention  ICMJE
  • Dietary Supplement: Lycium barbarum polysaccharide
    Experimental groups take Lycium barbarum polysaccharide (LBP) (400mg/day) for 6 weeks
  • Dietary Supplement: Placebo
    Placebo control group takes placebo (400mg/day) for 6 weeks.
Study Arms  ICMJE
  • Experimental: Lycium barbarum polysaccharide
    Experimental group takes Lycium barbarum polysaccharide (LBP) tablet (400mg/day) for 6 weeks
    Intervention: Dietary Supplement: Lycium barbarum polysaccharide
  • 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.
    Intervention: Dietary Supplement: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: October 10, 2019)
284
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 1, 2020
Estimated Primary Completion Date July 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Kangguang Lin, MD, PhD 13560360144 klin@connect.hku.hk
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04124276
Other Study ID Numbers  ICMJE Guangzhou Brain LBPMD
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kangguang Lin, Guangzhou Psychiatric Hospital
Study Sponsor  ICMJE Guangzhou Psychiatric Hospital
Collaborators  ICMJE The Fifth Affiliated Hospital of Guangzhou Medical University
Investigators  ICMJE
Principal Investigator: Kangguang Lin, MD, PhD Guangzhou Brain Hospital (Guangzhou Huiai Hospital)
PRS Account Guangzhou Psychiatric Hospital
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP