Subthreshold depression is a highly prevalent condition in adolescents who are at high risk for developing major depressive disorder. In preclinical models of neurological and psychiatric diseases, Lycium barbarum polysaccharide (LBP) extracted from Goji berries had anti- depressant effects including but not limited to anti-oxidative and anti-inflammatory properties. However, the effect of LBP on subthreshold depression is unclear. To investigate the clinical efficacy and safety of LBP for treating subthreshold depression in adolescents, we conducted a randomized, double-blind, placebo-controlled trial (RCT) with 29 adolescents with subthreshold depression recruited at The Fifth Affiliated Hospital of Guangzhou Medical University. The participants were randomly assigned to groups where they received either 300 mg LBP (LBP group, n = 15, 3 boys and 12 girls aged 15.13 ± 2.17 years) or a placebo (placebo group, n = 14, 2 boys and 12 girls aged 15 ± 1.71 years) for 6 successive weeks. Interim analyses revealed that the LBP group exhibited a greater change in Hamilton Depression Scale (HAMD-24) scores relative to the baseline and a higher remission rate (HAMD-24 total score ≤ 7) at 6 weeks compared with the placebo group. Scores on the Beck Depression Inventory-Ⅱ(BDI-II), Pittsburgh Sleep Quality Index (PSQI), Kessler Psychological Distress Scale (Kessler), and Screen for Child Anxiety-Related Emotional Disorders (SCARED) were similar between the LBP and placebo groups. No side effects related to the intervention were reported in either group. These results indicate that LBP administration reduced depressive symptoms in adolescents with subthreshold depression. Furthermore, LBP was well tolerated with no treatment-limiting adverse events. Clinical trials involving a larger sample size are needed to further confirm the anti-depressive effects of LBP in adolescents with subthreshold depression. This study was approved by the Medical Ethics Committee of the Fifth Affiliated Hospital of Guangzhou Medical University (Guangzhou, China; approval No. L2019-08) on April 4, 2019 and was registered on ClinicalTrials.gov (identifier: NCT04032795) on July 25, 2019.

Department of Affective Disorders,The Affiliated Brain Hospital of Guangzhou Medical University(Guangzhou Huiai Hospital),Guangzhou,Guangdong Province,China;Laboratory of Emotion and Cognition,The Affiliated Hospital of Guangzhou Medical University(Guangzhou Huiai Hospital),Guangzhou,Guangdong Province,China;Department of Psychiatry,The Fifth Affiliated Hospital of Guangzhou Medical University,Guangzhou,Guangdong Province,China;Canadian Rapid Treatment Center of Excellence,Mississauga,ON,Canada;Mood Disorders Psychopharmacology Unit,Poul Hansen Family Centre for Depression,University,Health Network,Toronto,ON,Canada;Department of Psychiatry,University of Toronto,Toronto,ON,Canada;Brain and Cognition Discovery Foundation,Toronto,ON,Canada;Ministry of Education Joint International Research Laboratory of CNS Regeneration,Jinan University,Guangzhou,Guangdong Province,China;Neuroscience and Neurorehabilitation Institute,University of Health and Rehabilitation Sciences,Qingdao,Shandong Province,China

[1]Xiaoyue Li;Xuan Mo;Tao Liu;Robin Shao;Kayla Teopiz;Roger S.McIntyre;Kwok-Fai So;Kangguang Lin-.Efficacy of Lycium barbarum polysaccharide in adolescents with subthreshold depression: interim analysis of a randomized controlled study)[J].中国神经再生研究（英文版）,2022(07):1582-1587

Subthreshold,Goji,L2019,NCT04032795

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