Subthreshold DepressionNCT04032795
Evaluation of Efficacy of Lycium Barbarum Polysaccharide in People With Subthreshold Depression
A study testing Lycium barbarum polysaccharide in people with Subthreshold Depression and Depressive Symptoms, run by Guangzhou Psychiatric Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Subthreshold Depression, Depressive Symptoms, Anxious Symptoms
- What is being tested?
- Lycium barbarum polysaccharide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 172 participants
- Where
- 1 siteChina
- Study dates
- 15 May 2019to 30 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 15-25 scores in the Beck Depression Rating Scale (BDI- II)
- There is no contraindication of taking LBP.
Who cannot join
- Current treatment for a mental health problem from a mental health professional
- Current and lifetime history of psychiatric disorders (e.g major depressive disorder, as ascertained by CIDI
- Systemic disease requiring regular medication.
- There are suicidal ideation, suicidal attempt, suicide behavior and attempted suicide.
- Dislike of or allergy to goji berry
- Hormone or Endocrine therapeutic drugs are being taken.
- Long-term use of lycium chinensis in recent three months
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Affiliated Fifth Hospital of Guangzhou Medical University
Guangzhou, Guangdong
Xuan Mo, M.D
About this study
Official title: Evaluation of Efficacy of Lycium Barbarum Polysaccharide in People With Subthreshold Depression: a Randomized, Placebo-controlled Trial
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.
- Being tested
- Lycium barbarum polysaccharide, Placebo
- Keywords
- Major Depressive Disorder, Lycium barbarum polysaccharide, depressive symptoms, anxious symptoms
- Medical subject headings
- Depression, Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lycium barbarum polysaccharideDietary supplement
Experimental group takes Lycium barbarum polysaccharide (LBP) tablet (300mg/day)for 6 weeks
PlaceboDietary supplement
Placebo-controlled group take he placebo capsules that are identical in shape, color, and taste to LBP tablet.
| Study group | Role | What they receive |
|---|---|---|
| Lycium barbarum polysaccharide (LBP) | Experimental | Experimental group takes LBP tablet (300mg/day) for 6 weeks Receives: Dietary Supplement: Lycium barbarum polysaccharide |
| Placebo | Placebo comparator | Placebo control group takes placebo 6 weeks. The placebos are the same with the LBP tablets in appearance and taste. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 6 weeks
Secondary outcomes (4)
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.
Measured: 4 and 6 weeks
Changes in sleep quality
Changes in Pittsburgh Sleep Quality Index (PSQI)
Measured: 6 weeks
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.
Measured: 6 weeks
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.
Measured: 6 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2019
- Study start15 May 2019
- Primary completion30 Dec 2021 (estimated)
- Study completion30 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Subthreshold DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 172 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou Psychiatric Hospital
- Sponsor type
- Other government
- Collaborators
- Fifth Affiliated Hospital of Guangzhou Medical University
- Responsible party
- Principal investigator, Kangguang Lin, Guangzhou Psychiatric Hospital
- Investigators
- Kwok-Fai So, PhD, Study chair, Guangzhou Medical UniversityKangguang Lin, MD,PhD, Study director, Guangzhou Brain Hospital (Guangzhou Huiai Hospital);The fifth affiliated hospital of Guangzhou Medical UniversityXuan Mo, MD, Principal investigator, Fifth Affiliated Hospital of Guangzhou Medical UniversityGuiyun Xu, MD, Principal investigator, Guangzhou Brain Hospital (Guangzhou Huiai Hospital)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04032795
- Sponsor's protocol ID
- Guangzhou Brain LBP
- Status last verified
- Nov 2021
- First submitted
- 19 Jul 2019
- Last updated
- 19 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Efficacy of Lycium Barbarum Polysaccharide in People With Subthreshold Depression: a Randomized, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT04032795
- Acronym / sponsor ID
- Guangzhou Brain LBP
- Keywords
- Major Depressive Disorder, Lycium barbarum polysaccharide, depressive symptoms, anxious symptoms
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 172 participants (estimated)
- Lead sponsor
- Guangzhou Psychiatric HospitalOther government
- Collaborators
- Fifth Affiliated Hospital of Guangzhou Medical University
- Study start
- 15 May 2019 (actual)
- Primary completion
- 30 Dec 2021 (estimated)
- Study completion
- 30 Dec 2021 (estimated)
- First posted
- 25 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lycium barbarum polysaccharide (LBP) | Experimental | Dietary Supplement: Lycium barbarum polysaccharideExperimental group takes LBP tablet (300mg/day) for 6 weeks |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo control group takes placebo 6 weeks. The placebos are the same with the LBP tablets in appearance and taste. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 15-25 scores in the Beck Depression Rating Scale (BDI- II)
- There is no contraindication of taking LBP.
Key exclusion criteria (7 listed)
- Current treatment for a mental health problem from a mental health professional
- Current and lifetime history of psychiatric disorders (e.g major depressive disorder, as ascertained by CIDI
- Systemic disease requiring regular medication.
- There are suicidal ideation, suicidal attempt, suicide behavior and attempted suicide.
- Dislike of or allergy to goji berry
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lycium barbarum polysaccharideExperimental group takes Lycium barbarum polysaccharide (LBP) tablet (300mg/day)for 6 weeks | Dietary supplement | Lycium barbarum polysaccharide (LBP) |
| PlaceboPlacebo-controlled group take he placebo capsules that are identical in shape, color, and taste to LBP tablet. | Dietary supplement | Placebo |
Primary outcome
Mean changes from baseline in the 21-item Hamilton Depression Rating Scale (24-HAMD)
Time frame: 6 weeks
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).
4 secondary outcomes
Changes in The Screen for Child Anxiety Related Disorders (SCARED)
Time frame: 4 and 6 weeks
Changes in sleep quality
Time frame: 6 weeks
Depression severity as measured by BDI2 and Kessler Scale (K10)
Time frame: 6 weeks
Mean change from baseline in the Beck Depression Inventory-II (BDI-2)total scores
Time frame: 6 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2021.
- Derived from this study: PubMed 34916444Li 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lycium barbarum polysaccharide in people with Subthreshold Depression and Depressive Symptoms, run by Guangzhou Psychiatric Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kangguang Lin, MD (8613560360144, linkangguang@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean changes from baseline in the 21-item Hamilton Depression Rating Scale (24-HAMD) (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04032795, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2021.