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
|Condition or disease||Intervention/treatment||Phase|
|Major Depressive Disorder Depression Depressive Disorder||Dietary Supplement: Lycium barbarum polysaccharide Dietary Supplement: Placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||284 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
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.
- 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%.
- 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
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
|Contact: Kangguang Lin, MD, PhDemail@example.com|
|Guangzhou Brain Hospital (Guangzhou Huiai Hospital)||Not yet recruiting|
|Guanzhou, Guangdong, China, 510370|
|Contact: Kangguang Lin, MD，PhD 13560360144 firstname.lastname@example.org|
|Principal Investigator:||Kangguang Lin, MD, PhD||Guangzhou Brain Hospital (Guangzhou Huiai Hospital)|