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

NCT ID: NCT04124276

Last Updated: 2020-10-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

284 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-01

Study Completion Date

2021-06-01

Brief Summary

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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.

Detailed Description

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Conditions

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Major Depressive Disorder Depression Depressive Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Lycium barbarum polysaccharide

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

Group Type EXPERIMENTAL

Lycium barbarum polysaccharide

Intervention Type DIETARY_SUPPLEMENT

Experimental groups take Lycium barbarum polysaccharide (LBP) (300mg/day) for 6 weeks

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Placebo control group takes placebo (300mg/day) for 6 weeks.

Interventions

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Lycium barbarum polysaccharide

Experimental groups take Lycium barbarum polysaccharide (LBP) (300mg/day) for 6 weeks

Intervention Type DIETARY_SUPPLEMENT

Placebo

Placebo control group takes placebo (300mg/day) for 6 weeks.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fifth Affiliated Hospital of Guangzhou Medical University

OTHER

Sponsor Role collaborator

Guangzhou Psychiatric Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Kangguang Lin

Deputy director, Department of Affective Disorder

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kangguang Lin, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Guangzhou Brain Hospital (Guangzhou Huiai Hospital)

Locations

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Guangzhou Brain Hospital (Guangzhou Huiai Hospital)

Guanzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Kangguang Lin, MD, PhD

Role: CONTACT

[email protected]
13560360144

Facility Contacts

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Kangguang Lin, MD，PhD

Role: primary

[email protected]
13560360144

Other Identifiers

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Guangzhou Brain LBPMD

Identifier Type: -

Identifier Source: org_study_id