An interventional study of Lycium barbarum polysaccharide and Placebo in Major Depressive Disorder, Depression and Depressive Disorder, sponsored by Guangzhou Psychiatric Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2020-10-30.
Sponsored by Guangzhou Psychiatric Hospital · Not applicable, Interventional, and Treatment
Among 206 studies in Depressive Disorder, Major with a site in China — 74 open to participants now, 77 under way, 5 of them phase 3. Depressive Disorder, Major · China.
Among the 206 studies in Depressive Disorder, Major with a site in China, this one is the 38th largest by planned enrollment of the 173 interventional ones, is one of 11 that started in 2019, is one of 99 with no phase, and was the 61st registered.
3,041 studies on the registry are indexed under Depressive Disorder, Major; 588 are open to participants now.
This study's planned enrollment of 284 is above the median of 79 across 2,530 interventional studies indexed under Depressive Disorder, Major.
Browse Depressive Disorder, Major studies →74 of the 206 studies in Depressive Disorder, Major with a site in China are open now, in 12 countries. Each count lists the studies.
Of the 410 Depressive Disorder, Major studies recruiting now, 92 (22%) set no upper age limit and 292 (71%) stop at 75 or younger; 54 take children under 18; 98 take healthy volunteers.
This study: 18 Years to 60 Years · all sexes · no healthy volunteers.
The full table on the hub →206 studies; the count open now beside each. This study's row is marked.
First in 2004; this study’s year is marked. 11 started in 2019.
Median enrollment 120 across the 173 interventional studies, 240 across the 33 observational. Of the 76 that completed or were terminated, 8 (11%) have results posted.
43 of 206 have an industry lead sponsor. The 10 most frequent:
Guangzhou Psychiatric Hospital is the lead sponsor of 13 studies on the registry; 2 are open to participants now.
Guangzhou Psychiatric Hospital has 5 studies filed under Depressive Disorder, Major — fewer than ten, so there is no comparison to draw.
21 of the studies in Depressive Disorder, Major with a site in China that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04984512Phase 3Sunshine Lake Pharma Co., Ltd.The Efficacy And Safety Of Mitizodone Phosphate Tablets In The Treatment of Patient With Major Depressive Disorder | 2027-07 |
| NCT07282366Jian-Jun OuVideo Intervention to Reduce Depression-related Stigma Among Adolescents | 2026-11-20 |
| NCT06913309Peking University Sixth HospitalClinical Efficacy, Safety, and Applicability of Home-based Bright Light Therapy in Outpatient Adolescents With Major Depressive Disorder | 2026-11-30 |
| NCT06409325Shanghai Mental Health CenterEffectiveness of MST Versus ECT for Major Depressive Episode | 2026-12-30 |
| NCT07873060Qilu Hospital of Shandong UniversityComparing 10 Hz rTMS and iTBS for Adolescent Depression | 2026-12-31 |
Among the 206 studies in Depressive Disorder, Major with a site in China, from their registry updates:
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.
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.
Exclusion Criteria:
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.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
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.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Experimental group takes Lycium barbarum polysaccharide (LBP) tablet (300mg/day) for 6 weeks
Dietary Supplement: Lycium barbarum polysaccharide
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
Experimental groups take Lycium barbarum polysaccharide (LBP) (300mg/day) for 6 weeks
Placebo control group takes placebo (300mg/day) for 6 weeks.
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%.
Time frame: 4weeks, 6weeks
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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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)
Time frame: 6 weeks
Changes in serum triglyceride levels
The blood of patients are sent to clinical laboratory of our hospital to measure serum triglyceride levels
Time frame: 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
Time frame: 6 weeks
Started Nov 2019 (actual). Primary completion is estimated for Dec 2020, 13 months after the start.
Of 647 non-industry interventional studies with no phase under Depressive Disorder, Major, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 55. This study's planned 13 months is below that.
Counting every sponsor, half of 687 studies reached it within 33 months; a quarter within 17 and three quarters within 55.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Lycium barbarum polysaccharide
Guangzhou Psychiatric Hospital