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

• ClinicalTrials.gov Identifier: NCT04124276
• Recruitment Status: Not yet recruiting
• First Posted: October 11, 2019
• Last Update Posted: October 11, 2019
• Sponsor: Guangzhou Psychiatric Hospital
• Collaborator: The Fifth Affiliated Hospital of Guangzhou Medical University
• Information provided by (Responsible Party): Kangguang Lin, Guangzhou Psychiatric Hospital

Tracking Information

• First Submitted Date: October 5, 2019
• First Posted Date: October 11, 2019
• Last Update Posted Date: October 11, 2019
• Estimated Study Start Date: November 1, 2019
• Estimated Primary Completion Date: July 30, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Evaluation of Efficacy of Lycium Barbarum Polysaccharide in Patients With Major Depressive Disorder
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment

Condition

• Major Depressive Disorder
• Depression
• Depressive Disorder

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Not yet recruiting
• Estimated Enrollment (submitted: October 10, 2019): 284
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: October 1, 2020
• Estimated Primary Completion Date: July 30, 2020 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 60 Years (Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Kangguang Lin, MD, PhD; 13560360144; klin@connect.hku.hk

• Listed Location Countries: China

Administrative Information

• NCT Number: NCT04124276
• Other Study ID Numbers: 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: Not Provided
• Responsible Party: Kangguang Lin, Guangzhou Psychiatric Hospital
• Study Sponsor: Guangzhou Psychiatric Hospital
• Collaborators: The Fifth Affiliated Hospital of Guangzhou Medical University

Investigators

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

• PRS Account: Guangzhou Psychiatric Hospital
• Verification Date: October 2019