Evaluation of Efficacy of Lycium Barbarum Polysaccharide in Patients With Major Depressive Disorder

Guangzhou Psychiatric Hospital

Status: Unknown

Conditions: Major Depressive Disorder; Depression; Depressive Disorder

Treatments: Dietary Supplement: Lycium barbarum polysaccharide; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04124276

Guangzhou Brain LBPMD

Details and patient eligibility

About

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.

Enrollment: 284 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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284 participants in 2 patient groups, including a placebo group

Lycium barbarum polysaccharide

Experimental group

Description:

Experimental group takes Lycium barbarum polysaccharide (LBP) tablet (300mg/day) for 6 weeks

Treatment:

Dietary Supplement: Lycium barbarum polysaccharide

Placebo

Placebo Comparator group

Description:

Placebo control group takes placebo (300mg/day) for 6 weeks. The placebos are the same with the LBP tablets in appearance and taste.

Treatment:

Dietary Supplement: Placebo