ClinicalTrials.gg
Status unknownNCT04032795Updated Nov 19, 2021

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

An interventional study of Lycium barbarum polysaccharide and Placebo in Subthreshold Depression, Depressive Symptoms and Anxious Symptoms, sponsored by Guangzhou Psychiatric Hospital. Status unknown at 1 site in China. Open to participants aged 12 Years to 18 Years. Per ClinicalTrials.gov, last updated 2021-11-19.

Sponsored by Guangzhou Psychiatric Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Nov 2021), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
172
Allocation
Randomized
Ages
12 Years to 18 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 357 studies in Depression with a site in China — 118 open to participants now, 137 under way, 3 of them phase 3. Depression · China.

Planned enrollment
114th of 283
172 · median 132
Started
2019
with 16 others
No phase
217 of 357
70 open now
Registered
87th of 357
by date
Lead sponsor
7 of 357
Guangzhou Psychiatric Hospital

Among the 357 studies in Depression with a site in China, this one is the 114th largest by planned enrollment of the 283 interventional ones, is one of 17 that started in 2019, is one of 217 with no phase, and was the 87th registered.

By phase

357 studies; the count open now beside each. This study's row is marked.

No phasethis study217 · 70 open
Observational74 · 30 open
Phase 424 · 10 open
Phase 115 · 2 open
Phase 211 · 2 open
Phase 37 · 2 open
Phase 2/36 · 1 open
Phase 1/23 · 1 open

By the year they started

First in 2006; this study’s year is marked. 17 started in 2019.

Size and results

Median enrollment 132 across the 283 interventional studies, 306 across the 74 observational. Of the 140 that completed or were terminated, 9 (6%) have results posted.

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02

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

03

Conditions studied

  • Subthreshold Depression
  • Depressive Symptoms
  • Anxious Symptoms

Keywords

  • Major Depressive Disorder
  • Lycium barbarum polysaccharide
  • depressive symptoms
  • anxious symptoms
04

Who can participate

Ages eligible
12 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. 15-25 scores in the Beck Depression Rating Scale (BDI- II)
  2. There is no of taking LBP.

Exclusion criteria

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
172 participants (estimated)

Study arms

  • Experimental
    Lycium barbarum polysaccharide (LBP)

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

    Dietary Supplement: Lycium barbarum polysaccharide

  • Placebo comparator
    Placebo

    Placebo control group takes placebo 6 weeks. The placebos are the same with the LBP tablets in appearance and taste.

    Dietary Supplement: Placebo

Interventions

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

  • Dietary supplementPlacebo

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

06

What researchers measure

Primary outcomes

  1. Mean changes from baseline in the 21-item Hamilton Depression Rating Scale (24-HAMD)

    The 24-item HAM-D scale is widely used to assess the severity of depression.The scale is a 21-item assessment used to measure depression severity. Items were rated on a scale from 0 (symptoms not present) to a maximum of 2 to 4 (symptom extremely severe) for a total score ranging from 0 (not at all depressed) to 64 (severely depressed).

    Time frame: 6 weeks

Secondary outcomes

  1. Changes in The Screen for Child Anxiety Related Disorders (SCARED)

    The SCARED is a child and parent self-report instrument used to screen for childhood anxiety disorders including general anxiety disorder, separation anxiety disorder, panic disorder, and social phobia.

    Time frame: 4 and 6 weeks

  2. Changes in sleep quality

    Changes in Pittsburgh Sleep Quality Index (PSQI)

    Time frame: 6 weeks

  3. Depression severity as measured by BDI2 and Kessler Scale (K10)

    The Kessler psychological distress scale (K10) is a widely used, simple self-report measure of psychological distress which can be used to identify those in need of further assessment for anxiety and depression.

    Time frame: 6 weeks

  4. Mean change from baseline in the Beck Depression Inventory-II (BDI-2)total scores

    The BDI-II is a 21-item self-report measure of depressive symptom.Remission was defined as equal or less than 8 scores on BDI-2.

    Time frame: 6 week

Other outcomes

  1. Treatment-emergent symptom side effect (TESS) scale.

    Side effect was evaluated by treatment-emergent symptom side effect (TESS) scale.

    Time frame: 4 and 6 weeks

07

Study locations

1 of 1 sites recruiting
  • The Affiliated Fifth Hospital of Guangzhou Medical University
    Guangzhou, Guangdong, China
    Recruiting
    • Xuan Mo, M.D · Contact
08

References and documents

Publications

  • 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. PubMed 34916444 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started May 2019 (actual). Primary completion is estimated for Dec 2021, 31 months after the start.

Of 3,468 non-industry interventional studies with no phase under Depression, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 41. This study's planned 31 months is above that.

Counting every sponsor, half of 3,566 studies reached it within 21 months; a quarter within 9 and three quarters within 41.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 19, 2019
First posted
Jul 25, 2019
StartActual
May 15, 2019
Primary completionEst.
Dec 30, 2021
CompletionEst.
Dec 30, 2021
Last update
Nov 19, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 19, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04032795
Lead sponsor
Guangzhou Psychiatric Hospital
Collaborators
Fifth Affiliated Hospital of Guangzhou Medical University
Responsible party
Kangguang Lin (Deputy director, Department of Affective disorders, Guangzhou Psychiatric Hospital) — Principal investigator
First posted
Jul 25, 2019
Start date
May 15, 2019
Primary completion
Dec 30, 2021 (estimated)
Completion
Dec 30, 2021 (estimated)
Last update
Nov 19, 2021

Study contacts

Kangguang Lin, MD
Contact
linkangguang@163.com
8613560360144
Xuan Mo, MD
Contact
mx7628@126.com
8615622326389
Kwok-Fai So, PhD
study chair · Guangzhou Medical University
Kangguang Lin, MD,PhD
study director · Guangzhou Brain Hospital (Guangzhou Huiai Hospital);The fifth affiliated hospital of Guangzhou Medical University
Xuan Mo, MD
principal investigator · Fifth Affiliated Hospital of Guangzhou Medical University
Guiyun Xu, MD
principal investigator · Guangzhou Brain Hospital (Guangzhou Huiai Hospital)

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.

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