NCT04124276

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
284

participants targeted

Target at P75+ for not_applicable major-depressive-disorder

Timeline
Completed

Started Nov 2019

Shorter than P25 for not_applicable major-depressive-disorder

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 5, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 11, 2019

Completed
21 days until next milestone

Study Start

First participant enrolled

November 1, 2019

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2020

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
Last Updated

October 30, 2020

Status Verified

October 1, 2020

Enrollment Period

1.2 years

First QC Date

October 5, 2019

Last Update Submit

October 28, 2020

Conditions

Major Depressive DisorderDepressionDepressive Disorder

Keywords

Major Depressive DisorderLycium barbarum polysaccharide

Outcome Measures

Primary Outcomes (1)

  • Reduction rate of Hamilton Depression Scale (HDRS)

    HDRS is used to measure the depressive severity；its measured time range is within the past week. In this study, version of 24-items is used. The patients are depressed when the total score are greater than 19 points, and there are no depression when the total scores are less than points. Clinical control, HDRS score reduction rate≥75%; significant progress, 50%≤HDRS score reduction rate \< 75%; progress, 25%≤HDRS score reduction rate \< 50%; ineffectiveness, HDRS score reduction rate \< 25%. significant efficiency = (clinical control + significant progress) / sample number×100%.

    4weeks, 6weeks

Secondary Outcomes (7)

  • Changes in depressive severity measured by Beck Depression Inventory (BDI) scale and Kessler Scale(K10)

    4 weeks, 6 weeks

  • Changes in sleep quality

    4 weeks, 6 weeks

  • Changes in cognitive function

    4 weeks, 6 weeks

  • Changes in social adaptive levels

    4 weeks, 6 weeks

  • Changes in serum brain-derived neurotrophic factor (BDNF) levels

    6 weeks

  • +2 more secondary outcomes

Study Arms (2)

Lycium barbarum polysaccharide

EXPERIMENTAL

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

Dietary Supplement: Lycium barbarum polysaccharide

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Interventions

Lycium barbarum polysaccharideDIETARY_SUPPLEMENT

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

Lycium barbarum polysaccharide
PlaceboDIETARY_SUPPLEMENT

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

Placebo

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age: 18-60 years old
  • Sex: both men and women
  • Compliance with the Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) diagnostic criteria for major depressive disorder
  • Hamilton Depression Scale scored more than 18 points.
  • No contraindication of taking Lycium barbarum polysaccharide

You may not qualify if:

  • Comorbidity with other mental disorders
  • Severe somatic diseases
  • Current use of traditional Chinese medicine
  • Suicide concept, attempt, act and attempted suicide
  • Psychiatric symptoms
  • Taking hormones and endocrine drugs
  • Long-term use of wolfberry in recent three months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guangzhou Brain Hospital (Guangzhou Huiai Hospital)

Guanzhou, Guangdong, 510370, China

RECRUITING

MeSH Terms

Conditions

Depressive Disorder, MajorDepressionDepressive Disorder

Interventions

lycium barbarum polysaccharide

Condition Hierarchy (Ancestors)

Mood DisordersMental DisordersBehavioral SymptomsBehavior

Study Officials

  • Kangguang Lin, MD, PhD

    Guangzhou Brain Hospital (Guangzhou Huiai Hospital)

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kangguang Lin, MD, PhD

CONTACT

13560360144klin@connect.hku.hk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Deputy director, Department of Affective Disorder

Study Record Dates

First Submitted

October 5, 2019

First Posted

October 11, 2019

Study Start

November 1, 2019

Primary Completion

December 30, 2020

Study Completion

June 1, 2021

Last Updated

October 30, 2020

Record last verified: 2020-10

Locations

CN(1)