Clinical trial NCT04032795: Evaluation of Efficacy of Lycium Barbarum Polysaccharide in People With Subthreshold Depression
Official title: Evaluation of Efficacy of Lycium Barbarum Polysaccharide in People With Subthreshold Depression: a Randomized, Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Subthreshold Depression
Depressive Symptoms
Anxious Symptoms
Keywords: Major Depressive Disorder
Lycium barbarum polysaccharide
depressive symptoms
anxious symptoms
Lead sponsor: Guangzhou Psychiatric Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Fifth Affiliated Hospital of Guangzhou Medical University
First posted: 2019-07-25
Enrollment: 172
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 people with subthreshold depression.The purpose of this clinical trial is to investigate the efficacy of LBP in people with subthreshold depression.


Eligibility criteria: Inclusion Criteria:

1. 15-25 scores in the Beck Depression Rating Scale (BDI- II)
2. There is no contraindication of taking LBP.

Exclusion Criteria:

1. Current treatment for a mental health problem from a mental health professional
2. Current and lifetime history of psychiatric disorders (e.g major depressive disorder, as ascertained by CIDI
3. Systemic disease requiring regular medication.
4. There are suicidal ideation, suicidal attempt, suicide behavior and attempted suicide.
5. Dislike of or allergy to goji berry
6. Hormone or Endocrine therapeutic drugs are being taken.
7. Long-term use of lycium chinensis in recent three months

Primary outcomes:
measure: Mean changes from baseline in the 21-item Hamilton Depression Rating Scale (24-HAMD)
timeFrame: 6 weeks
Secondary outcomes:
measure: Changes in The Screen for Child Anxiety Related Disorders (SCARED)
timeFrame: 4 and 6 weeks
measure: Changes in sleep quality
timeFrame: 6 weeks
measure: Depression severity as measured by BDI2 and Kessler Scale (K10)
timeFrame: 6 weeks
measure: Mean change from baseline in the Beck Depression Inventory-II (BDI-2)total scores
timeFrame: 6 week
Other outcomes:
measure: Treatment-emergent symptom side effect (TESS) scale.
timeFrame: 4 and 6 weeks
Locations:
city: Guangzhou
country: China
facility: The Affiliated Fifth Hospital of Guangzhou Medical University
state: Guangdong
Study officials:
affiliation: Guangzhou Medical University
name: Kwok-Fai So, PhD
role: STUDY_CHAIR
affiliation: Guangzhou Brain Hospital (Guangzhou Huiai Hospital);The fifth affiliated hospital of Guangzhou Medical University
name: Kangguang Lin, MD,PhD
role: STUDY_DIRECTOR
affiliation: Fifth Affiliated Hospital of Guangzhou Medical University
name: Xuan Mo, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Guangzhou Brain Hospital (Guangzhou Huiai Hospital)
name: Guiyun Xu, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Li X, Mo X, Liu T, Shao R, Teopiz K, McIntyre RS, So KF, Lin K. Efficacy of Lycium barbarum polysaccharide in adolescents with subthreshold depression: interim analysis of a randomized controlled study. Neural Regen Res. 2022 Jul;17(7):1582-1587. doi: 10.4103/1673-5374.330618.