Clinical trial NCT04124276: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Major Depressive Disorder
Depression
Depressive Disorder
Keywords: Major Depressive Disorder
Lycium barbarum polysaccharide
Lead sponsor: Guangzhou Psychiatric Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Fifth Affiliated Hospital of Guangzhou Medical University
First posted: 2019-10-11
Enrollment: 284
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: 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 patients with major depressive disorder (MDD). The purpose of this clinical trial is to investigate the efficacy of LBP in patients with MDD.


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

Primary outcomes:
measure: Reduction rate of Hamilton Depression Scale (HDRS)
timeFrame: 4weeks, 6weeks
Secondary outcomes:
measure: Changes in depressive severity measured by Beck Depression Inventory (BDI) scale and Kessler Scale(K10)
timeFrame: 4 weeks, 6 weeks
measure: Changes in sleep quality
timeFrame: 4 weeks, 6 weeks
measure: Changes in cognitive function
timeFrame: 4 weeks, 6 weeks
measure: Changes in social adaptive levels
timeFrame: 4 weeks, 6 weeks
measure: Changes in serum brain-derived neurotrophic factor (BDNF) levels
timeFrame: 6 weeks
measure: Changes in serum triglyceride levels
timeFrame: 6 weeks
measure: Changes in serum total cholesterol levels
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Guanzhou
country: China
facility: Guangzhou Brain Hospital (Guangzhou Huiai Hospital)
state: Guangdong
Study officials:
affiliation: Guangzhou Brain Hospital (Guangzhou Huiai Hospital)
name: Kangguang Lin, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: