Evaluation of Efficacy of Lycium Barbarum Polysaccharide in People With Subthreshold Depression
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|ClinicalTrials.gov Identifier: NCT04032795|
Recruitment Status : Not yet recruiting
First Posted : July 25, 2019
Last Update Posted : July 25, 2019
|Condition or disease||Intervention/treatment||Phase|
|Subthreshold Depression Depressive Symptoms Anxious Symptoms||Dietary Supplement: Lycium barbarum polysaccharide Dietary Supplement: Placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||172 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Evaluation of Efficacy of Lycium Barbarum Polysaccharide in People With Subthreshold Depression: a Randomized, Placebo-controlled Trial|
|Estimated Study Start Date :||August 5, 2019|
|Estimated Primary Completion Date :||July 30, 2020|
|Estimated Study Completion Date :||October 1, 2020|
Experimental: Lycium barbarum polysaccharide (LBP)
Experimental group takes LBP tablet (400mg/day) for 6 weeks
Dietary Supplement: Lycium barbarum polysaccharide
Experimental group takes Lycium barbarum polysaccharide (LBP) tablet (400mg/day)for 6 weeks
Placebo Comparator: Placebo
Placebo control group takes placebo 6 weeks. The placebos are the same with the LBP tablets in appearance and taste.
Dietary Supplement: Placebo
Placebo-controlled group take he placebo capsules that are identical in shape, color, and taste to LBP tablet.
- Percentage of Subjects Who Met Criteria for Remission Based on Beck Depression Inventory-II (BDI-2) [ Time Frame: 6 weeks ]The BDI-II is a 21-item self-report measure of depressive symptom.Remission was defined as equal or less than 8 scores on BDI-2.
- Changes in The Screen for Child Anxiety Related Disorders (SCARED) [ Time Frame: 4 and 6 weeks ]The SCARED is a child and parent self-report instrument used to screen for childhood anxiety disorders including general anxiety disorder, separation anxiety disorder, panic disorder, and social phobia.
- Changes in sleep quality [ Time Frame: 6 weeks ]Changes in Pittsburgh Sleep Quality Index (PSQI)
- Depression severity as measured by BDI2 and Kessler Scale (K10) [ Time Frame: 6 weeks ]The Kessler psychological distress scale (K10) is a widely used, simple self-report measure of psychological distress which can be used to identify those in need of further assessment for anxiety and depression.
- Treatment-emergent symptom side effect (TESS) scale. [ Time Frame: 4 and 6 weeks ]Side effect was evaluated by treatment-emergent symptom side effect (TESS) scale.
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): NCT04032795
|Contact: Kangguang Lin, MDemail@example.com|
|Contact: Xuan Mo, MDfirstname.lastname@example.org|
|Study Chair:||Kwok-Fai So, PhD||Guangzhou Medical University|
|Study Director:||Kangguang Lin, MD,PhD||Guangzhou Brain Hospital (Guangzhou Huiai Hospital);The fifth affiliated hospital of Guangzhou Medical University|
|Principal Investigator:||Xuan Mo, MD||The Fifth Affiliated Hospital of Guangzhou Medical University|
|Principal Investigator:||Guiyun Xu, MD||Guangzhou Brain Hospital (Guangzhou Huiai Hospital)|