Major Depressive DisorderNCT04124276
Evaluation of Efficacy of Lycium Barbarum Polysaccharide in Patients With Major Depressive Disorder
A study testing Lycium barbarum polysaccharide in people with Major Depressive Disorder and Depression, 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 18 to 60 years
- Conditions the study is for
- Major Depressive Disorder, Depression, Depressive Disorder
- 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
- 284 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2019to 1 Jun 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Guangzhou Brain Hospital (Guangzhou Huiai Hospital)
Guanzhou, Guangdong, 510370
Kangguang Lin, MD，PhD, 13560360144, klin@connect.hku.hk
About this study
Official title: Evaluation of Efficacy of Lycium Barbarum Polysaccharide in Patients With Major Depressive Disorder: a Randomized,Placebo-controled 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 patients with major depressive disorder (MDD). The purpose of this clinical trial is to investigate the efficacy of LBP in patients with MDD.
- Conditions
- Major Depressive Disorder, Depression, Depressive Disorder
- Being tested
- Lycium barbarum polysaccharide, Placebo
- Keywords
- Major Depressive Disorder, Lycium barbarum polysaccharide
- Medical subject headings
- Depressive Disorder, Major, Depression, Depressive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lycium barbarum polysaccharideDietary supplement
Experimental groups take Lycium barbarum polysaccharide (LBP) (300mg/day) for 6 weeks
PlaceboDietary supplement
Placebo control group takes placebo (300mg/day) for 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Lycium barbarum polysaccharide | Experimental | Experimental group takes Lycium barbarum polysaccharide (LBP) tablet (300mg/day) for 6 weeks Receives: 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. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%.
Measured: 4weeks, 6weeks
Secondary outcomes (7)
Changes in depressive severity measured by Beck Depression Inventory (BDI) scale and Kessler Scale(K10)
BDI scale is used to measure depressive severity by patients themselves. It's made of 21 items. Circle the number in front of the sentence that best suits your situation in according to the feeling for a week. The total score is obtained by adding up the delimited scores of each item. There is depression when the total score is greater than 15 points and there is no depression when the total score is less than 10 points. The K10 is a widely used, simple self-report measure of psychological distress which can be used to identify those in need of further assessment of depression and anxiety
Measured: 4 weeks, 6 weeks
Changes in sleep quality
Changes in Pittsburgh Sleep Quality Index (PSQI) scale. PSQI scale is used to evaluate sleep quality for last month. It's made of 7 items; every item is scored 1-4 point. Total score is obtained by adding up the points of 7 items. Total score range is 0~21 point. The sleep quality is worse when the total score is higher.
Measured: 4 weeks, 6 weeks
Changes in cognitive function
Cognitive function is assessed using the THINC-it. The THINC-it was recently developed by the THINC-it Task Force (http://thinc.progress.im/en) with the principal goal of time-efficient screening of cognitive impairments specifically among individuals with major depressive disorder as a routine component of their clinical care. THINC-it is a digitized cognitive assessment battery comprised of carefully selected gamified variations of well-known cognitive tasks (Spotter [Choice Reaction Time], Symbol Check [One-Back], Codebreaker [Digit Symbol Substitution Test], Trails [Trail Making Test-Part B]), and the Perceived Deficits Questionnaire for Depression-5-item (PDQ-5-D), a subjective self-report scale.
Measured: 4 weeks, 6 weeks
Changes in social adaptive levels
Measured by Global Assessment Function (GAF) scale. GAF scale is used to evaluate the condition and social adaptability in psychiatry patients. It's divided into 1 to 100 grades. The lower the score, the more serious the disease is. 91-100 points shows that the patients have good social adaptation and normal mental status.
Measured: 4 weeks, 6 weeks
Changes in serum brain-derived neurotrophic factor (BDNF) levels
We measure the serum BDNF levels by enzyme linked immunosorbent assay (ELISA)
Measured: 6 weeks
Changes in serum triglyceride levels
The blood of patients are sent to clinical laboratory of our hospital to measure serum triglyceride levels
Measured: 6 weeks
Changes in serum total cholesterol levels
The blood of patients are sent to clinical laboratory of our hospital to measure serum total cholesterol levels
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2019
- Study start1 Nov 2019
- Primary completion30 Dec 2020 (estimated)
- Study completion1 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies 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
- 284 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
- Kangguang Lin, MD, PhD, Principal investigator, Guangzhou Brain Hospital (Guangzhou Huiai Hospital)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04124276
- Sponsor's protocol ID
- Guangzhou Brain LBPMD
- Status last verified
- Oct 2020
- First submitted
- 5 Oct 2019
- Last updated
- 30 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Efficacy of Lycium Barbarum Polysaccharide in Patients With Major Depressive Disorder: a Randomized,Placebo-controled Trial
- ClinicalTrials.gov ID
- NCT04124276
- Acronym / sponsor ID
- Guangzhou Brain LBPMD
- Conditions
- Major Depressive Disorder, Depression, Depressive Disorder
- Keywords
- Major Depressive Disorder, Lycium barbarum polysaccharide
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 284 participants (estimated)
- Lead sponsor
- Guangzhou Psychiatric HospitalOther government
- Collaborators
- Fifth Affiliated Hospital of Guangzhou Medical University
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 30 Dec 2020 (estimated)
- Study completion
- 1 Jun 2021 (estimated)
- First posted
- 11 Oct 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 patients with major depressive disorder (MDD). The purpose of this clinical trial is to investigate the efficacy of LBP in patients with MDD.
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 | Experimental | Dietary Supplement: Lycium barbarum polysaccharideExperimental group takes Lycium barbarum polysaccharide (LBP) tablet (300mg/day) for 6 weeks |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo control group takes placebo (300mg/day) for 6 weeks. The placebos are the same with the LBP tablets in appearance and taste. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- Comorbidity with other mental disorders
- Severe somatic diseases
- Current use of traditional Chinese medicine
- Suicide concept, attempt, act and attempted suicide
- Psychiatric symptoms
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 groups take Lycium barbarum polysaccharide (LBP) (300mg/day) for 6 weeks | Dietary supplement | Lycium barbarum polysaccharide |
| PlaceboPlacebo control group takes placebo (300mg/day) for 6 weeks. | Dietary supplement | Placebo |
Primary outcome
Reduction rate of Hamilton Depression Scale (HDRS)
Time frame: 4weeks, 6weeks
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%.
7 secondary outcomes
Changes in depressive severity measured by Beck Depression Inventory (BDI) scale and Kessler Scale(K10)
Time frame: 4 weeks, 6 weeks
Changes in sleep quality
Time frame: 4 weeks, 6 weeks
Changes in cognitive function
Time frame: 4 weeks, 6 weeks
Changes in social adaptive levels
Time frame: 4 weeks, 6 weeks
Changes in serum brain-derived neurotrophic factor (BDNF) levels
Time frame: 6 weeks
Changes in serum triglyceride levels
Time frame: 6 weeks
Changes in serum total cholesterol levels
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2020.
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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.
Kangguang Lin, MD, PhD principal investigator
Guangzhou Brain Hospital (Guangzhou Huiai Hospital)
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 Major Depressive Disorder and Depression, 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 5 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 30 Oct 2020. 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, PhD (13560360144, klin@connect.hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction rate of Hamilton Depression Scale (HDRS) (time frame: 4weeks, 6weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Oct 2020.