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| Name | Class |
|---|---|
| Fifth Affiliated Hospital of Guangzhou Medical University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lycium barbarum polysaccharide (LBP) | Experimental | Experimental group takes LBP tablet (300mg/day) for 6 weeks |
|
| Placebo | Placebo Comparator | Placebo control group takes placebo 6 weeks. The placebos are the same with the LBP tablets in appearance and taste. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lycium barbarum polysaccharide | Dietary Supplement | Experimental group takes Lycium barbarum polysaccharide (LBP) tablet (300mg/day)for 6 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 4 and 6 weeks |
| Changes in sleep quality |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment-emergent symptom side effect (TESS) scale. | Side effect was evaluated by treatment-emergent symptom side effect (TESS) scale. | 4 and 6 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kangguang Lin, MD | Contact | 8613560360144 | linkangguang@163.com | |
| Xuan Mo, MD | Contact | 8615622326389 | mx7628@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Kwok-Fai So, PhD | Guangzhou Medical University | Study Chair |
| Kangguang Lin, MD,PhD | Guangzhou Brain Hospital (Guangzhou Huiai Hospital);The fifth affiliated hospital of Guangzhou Medical University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Affiliated Fifth Hospital of Guangzhou Medical University | Recruiting | Guangzhou | Guangdong | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34916444 | Derived | 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. |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
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| ID | Term |
|---|---|
| C500223 | lycium barbarum polysaccharide |
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| Placebo | Dietary Supplement | Placebo-controlled group take he placebo capsules that are identical in shape, color, and taste to LBP tablet. |
|
Changes in Pittsburgh Sleep Quality Index (PSQI) |
| 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. | 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. | 6 week |
| Xuan Mo, MD | Fifth Affiliated Hospital of Guangzhou Medical University | Principal Investigator |
| Guiyun Xu, MD | Guangzhou Brain Hospital (Guangzhou Huiai Hospital) | Principal Investigator |
| D001523 |
| Mental Disorders |