Ignite Creation Date:
2025-12-24 @ 1:58 PM
Ignite Modification Date:
2026-01-01 @ 12:30 AM
Study NCT ID:
NCT04032795
Status:
UNKNOWN
Last Update Posted:
2021-11-19
First Post:
2019-07-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Efficacy of Lycium Barbarum Polysaccharide in People With Subthreshold Depression
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}, {'id': 'D003865', 'term': 'Depressive Disorder, Major'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C500223', 'term': 'lycium barbarum polysaccharide'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 172}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-05-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2021-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-11-11', 'studyFirstSubmitDate': '2019-07-19', 'studyFirstSubmitQcDate': '2019-07-24', 'lastUpdatePostDateStruct': {'date': '2021-11-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Treatment-emergent symptom side effect (TESS) scale.', 'timeFrame': '4 and 6 weeks', 'description': 'Side effect was evaluated by treatment-emergent symptom side effect (TESS) scale.'}], 'primaryOutcomes': [{'measure': 'Mean changes from baseline in the 21-item Hamilton Depression Rating Scale (24-HAMD)', 'timeFrame': '6 weeks', 'description': '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).'}], 'secondaryOutcomes': [{'measure': 'Changes in The Screen for Child Anxiety Related Disorders (SCARED)', 'timeFrame': '4 and 6 weeks', 'description': '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.'}, {'measure': 'Changes in sleep quality', 'timeFrame': '6 weeks', 'description': 'Changes in Pittsburgh Sleep Quality Index (PSQI)'}, {'measure': 'Depression severity as measured by BDI2 and Kessler Scale (K10)', 'timeFrame': '6 weeks', 'description': '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.'}, {'measure': 'Mean change from baseline in the Beck Depression Inventory-II (BDI-2)total scores', 'timeFrame': '6 week', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Major Depressive Disorder', 'Lycium barbarum polysaccharide', 'depressive symptoms', 'anxious symptoms'], 'conditions': ['Subthreshold Depression', 'Depressive Symptoms', 'Anxious Symptoms']}, 'referencesModule': {'references': [{'pmid': '34916444', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. 15-25 scores in the Beck Depression Rating Scale (BDI- II)\n2. There is no contraindication of taking LBP.\n\nExclusion Criteria:\n\n1. Current treatment for a mental health problem from a mental health professional\n2. Current and lifetime history of psychiatric disorders (e.g major depressive disorder, as ascertained by CIDI\n3. Systemic disease requiring regular medication.\n4. There are suicidal ideation, suicidal attempt, suicide behavior and attempted suicide.\n5. Dislike of or allergy to goji berry\n6. Hormone or Endocrine therapeutic drugs are being taken.\n7. Long-term use of lycium chinensis in recent three months'}, 'identificationModule': {'nctId': 'NCT04032795', 'briefTitle': 'Evaluation of Efficacy of Lycium Barbarum Polysaccharide in People With Subthreshold Depression', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Guangzhou Psychiatric Hospital'}, 'officialTitle': 'Evaluation of Efficacy of Lycium Barbarum Polysaccharide in People With Subthreshold Depression: a Randomized, Placebo-controlled Trial', 'orgStudyIdInfo': {'id': 'Guangzhou Brain LBP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lycium barbarum polysaccharide (LBP)', 'description': 'Experimental group takes LBP tablet (300mg/day) for 6 weeks', 'interventionNames': ['Dietary Supplement: Lycium barbarum polysaccharide']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo control group takes placebo 6 weeks. The placebos are the same with the LBP tablets in appearance and taste.', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'Lycium barbarum polysaccharide', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Experimental group takes Lycium barbarum polysaccharide (LBP) tablet (300mg/day)for 6 weeks', 'armGroupLabels': ['Lycium barbarum polysaccharide (LBP)']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Placebo-controlled group take he placebo capsules that are identical in shape, color, and taste to LBP tablet.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xuan Mo, M.D', 'role': 'CONTACT'}], 'facility': 'The Affiliated Fifth Hospital of Guangzhou Medical University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Kangguang Lin, MD', 'role': 'CONTACT', 'email': 'linkangguang@163.com', 'phone': '8613560360144'}, {'name': 'Xuan Mo, MD', 'role': 'CONTACT', 'email': 'mx7628@126.com', 'phone': '8615622326389'}], 'overallOfficials': [{'name': 'Kwok-Fai So, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Guangzhou Medical University'}, {'name': 'Kangguang Lin, MD,PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Guangzhou Brain Hospital (Guangzhou Huiai Hospital);The fifth affiliated hospital of Guangzhou Medical University'}, {'name': 'Xuan Mo, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fifth Affiliated Hospital of Guangzhou Medical University'}, {'name': 'Guiyun Xu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Guangzhou Brain Hospital (Guangzhou Huiai Hospital)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Guangzhou Psychiatric Hospital', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Fifth Affiliated Hospital of Guangzhou Medical University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Deputy director, Department of Affective disorders', 'investigatorFullName': 'Kangguang Lin', 'investigatorAffiliation': 'Guangzhou Psychiatric Hospital'}}}}