Ignite Creation Date:
2025-12-25 @ 4:34 AM
Ignite Modification Date:
2026-02-24 @ 5:08 AM
Study NCT ID:
NCT01416818
Status:
UNKNOWN
Last Update Posted:
2011-08-15
First Post:
2011-08-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment of Depression in Parkinson's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2014-01-15', 'releaseDate': '2013-11-30'}], 'estimatedResultsFirstSubmitDate': '2013-11-30'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}, {'id': 'D010300', 'term': 'Parkinson Disease'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C516449', 'term': 'xiaoyao'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2008-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-08', 'completionDateStruct': {'date': '2011-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-08-11', 'studyFirstSubmitDate': '2011-08-11', 'studyFirstSubmitQcDate': '2011-08-11', 'lastUpdatePostDateStruct': {'date': '2011-08-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-08-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hamilton Depression Scale', 'timeFrame': '12 weeks', 'description': 'Change of Hamilton Depression Scale score on week 12 from baseline.'}], 'secondaryOutcomes': [{'measure': 'the responder rate (defined as score reduction of HAMD-17>=50%)', 'timeFrame': '12 weeks'}, {'measure': 'the Geriatric Depression Scale', 'timeFrame': '12 weeks', 'description': 'GDS-30'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Depression;', "Parkinson's disease;", 'antidepressant'], 'conditions': ["Depression in Parkinson's Disease"]}, 'descriptionModule': {'briefSummary': 'The goal of this study is to evaluate the efficacy of Traditional Chinese Medicine-"Xiaoyao Pill" (Herb extracts)on depression, compared to placebo and "Bupleurum+Ginkgo" in patients with Parkinson\'s disease.', 'detailedDescription': 'Depression as the most common non-motor comorbidity of Parkinson\'s disease (PD), have a negative impact on disability and quality of life.\n\nTraditional Chinese Medicine has shown effects on several depression. It is not known if TCM also is effective for depression in PD. This study is to investigate "Xiaoyao Pill", an antidepressant in TCM, on depression in PD.\n\nA total of 60 patients with depression in PD will be randomized to each of the three arms.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Parkinson's disease without dementia\n* Depression\n* Males or females\n* Willing and able to give informed consent\n\nExclusion Criteria:\n\n* cognitive dysfunction\n* other serious diseases"}, 'identificationModule': {'nctId': 'NCT01416818', 'briefTitle': "Treatment of Depression in Parkinson's Disease", 'organization': {'class': 'OTHER', 'fullName': 'Xuanwu Hospital, Beijing'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo-Controlled Study of "Xiaoyao Pill" Treatment of Depression in Patients With Parkinson\'s Disease', 'orgStudyIdInfo': {'id': '2008XYRCT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'group 1', 'interventionNames': ['Drug: Xiaoyao Pill']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'group 2', 'interventionNames': ['Drug: Bupleurum+Ginkgo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'group 3', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'Xiaoyao Pill', 'type': 'DRUG', 'description': 'herb extracts,were received two times a day for 12 weeks without dose changing.', 'armGroupLabels': ['group 1']}, {'name': 'Bupleurum+Ginkgo', 'type': 'DRUG', 'description': 'herb extracts, were received two times a day for 12 weeks without dose changing.', 'armGroupLabels': ['group 2']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'The placebo looked like herb extracts and were also received two times a day for 12 weeks without dose changing.', 'armGroupLabels': ['group 3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100053', 'city': 'Beijing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Piu Chan, M.D., Ph.D.', 'role': 'CONTACT', 'email': 'pbchan@hotmail.com', 'phone': '+86-10-83198677'}, {'role': 'CONTACT', 'email': 'pbchan90@gmail.com'}, {'name': 'Piu Chan, MD,PhD.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Xuanwu Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Jinglin Zhang, MD, PhD.', 'role': 'CONTACT', 'email': 'littlenumskull@hotmail.com', 'phone': '+86-10-83198677'}], 'overallOfficials': [{'name': 'Piu Chan, MD. PhD.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Xuanwu Hospital, Beijing'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xuanwu Hospital, Beijing', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Piu Chan, MD, PhD.', 'oldOrganization': 'Xuanwu Hospital'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2013-11-30', 'type': 'RELEASE'}, {'date': '2014-01-15', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Xuanwu Hospital, Beijing'}}}}