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Evaluation of Efficacy of Lycium Barbarum Polysaccharide in People With Subthreshold Depression

NCT ID: NCT04032795

Last Updated: 2021-11-19

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

172 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-15

Study Completion Date

2021-12-30

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

Detailed Description

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Conditions

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Subthreshold Depression Depressive Symptoms Anxious Symptoms

Keywords

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Major Depressive Disorder Lycium barbarum polysaccharide depressive symptoms anxious symptoms

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 (LBP)

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

Group Type EXPERIMENTAL

Lycium barbarum polysaccharide

Intervention Type DIETARY_SUPPLEMENT

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

Placebo

Placebo control group takes placebo 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-controlled group take he placebo capsules that are identical in shape, color, and taste to LBP tablet.

Interventions

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Lycium barbarum polysaccharide

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

Intervention Type DIETARY_SUPPLEMENT

Placebo

Placebo-controlled group take he placebo capsules that are identical in shape, color, and taste to LBP tablet.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Maximum Eligible Age

18 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 disorders

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kwok-Fai So, PhD

Role: STUDY_CHAIR

Guangzhou Medical University

Kangguang Lin, MD,PhD

Role: STUDY_DIRECTOR

Guangzhou Brain Hospital (Guangzhou Huiai Hospital);The fifth affiliated hospital of Guangzhou Medical University

Xuan Mo, MD

Role: PRINCIPAL_INVESTIGATOR

Fifth Affiliated Hospital of Guangzhou Medical University

Guiyun Xu, MD

Role: PRINCIPAL_INVESTIGATOR

Guangzhou Brain Hospital (Guangzhou Huiai Hospital)

Locations

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The Affiliated Fifth Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Kangguang Lin, MD

Role: CONTACT

Phone: 8613560360144

Email: [email protected]

Xuan Mo, MD

Role: CONTACT

Phone: 8615622326389

Email: [email protected]

Facility Contacts

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Xuan Mo, M.D

Role: primary

References

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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.

Reference Type DERIVED
PMID: 34916444 (View on PubMed)

Other Identifiers

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Guangzhou Brain LBP

Identifier Type: -

Identifier Source: org_study_id