Ignite Creation Date:
2025-12-24 @ 12:05 PM
Ignite Modification Date:
2025-12-27 @ 9:38 PM
Study NCT ID:
NCT05886361
Status:
COMPLETED
Last Update Posted:
2023-06-02
First Post:
2023-05-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Somatic Symptoms in Autism Spectrum Disorder: Data Integration
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000067877', 'term': 'Autism Spectrum Disorder'}], 'ancestors': [{'id': 'D002659', 'term': 'Child Development Disorders, Pervasive'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1423}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2022-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-23', 'studyFirstSubmitDate': '2023-05-04', 'studyFirstSubmitQcDate': '2023-05-23', 'lastUpdatePostDateStruct': {'date': '2023-06-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient health questionnaire-15, PHQ-15', 'timeFrame': '8 years', 'description': 'range from 0 to 2 for each item, total score range from 0 to 30. Higher the score, worse the level of somatization'}, {'measure': 'Health assessment questionnairse, HAQ', 'timeFrame': '8 years', 'description': 'range from 0 to 3 for each item. Higher the score, worse the disability'}, {'measure': 'Beck depression inventory, BDI', 'timeFrame': '8 years', 'description': 'range from 0 to 3 for each item. Higher the score, worse the depression'}, {'measure': 'Beck anxiety inventory', 'timeFrame': '8 years', 'description': 'range from 0 to 3 for each item. Total score 0 to 63. Higher the score, worse the anxiety'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Autism Spectrum Disorder', 'Somatic Symptom Disorder']}, 'descriptionModule': {'briefSummary': "Autistic patients have higher chances commorbid somatic symptoms. Therefore, it leads to more health-related concerns, such as autoimmune disease, gastrointestinal disease, cardiovascular disease, autonomic disorders. On average, autistic patient's life span is 16 years shorter than non-autistic patients. Furthermore, autistic patients are not able to convey or communicate their somatic symptoms in a clear and comprehensive manner. This leads to unable to receive proper health care in a timely manner."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '15 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'as mentioned earlier, it is a retrospective study with existed data. Therefore, the 1423 participants are already collected in the past. We separate these existed data into three groups as mentioned in the eligibility criteria', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASD group: diagnosed with DSM-5 autism spectrum disorder\n* clinical group: anxiety, depression, somatic disorder who are non-psychotic and non-organic\n* control group: healthy control without psychiatric disorder or chronic somatic symptoms\n* age between 15 and 70\n\nExclusion Criteria:\n\n* psychiatric disorders such as schezophrenia, mood disorder.\n* major physical disorder which can be potentially lethal\n* who cannot read or comprehend the survey and questionnaire'}, 'identificationModule': {'nctId': 'NCT05886361', 'briefTitle': 'Somatic Symptoms in Autism Spectrum Disorder: Data Integration', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'Somatic Symptoms in Autism Spectrum Disorder: Data Integration', 'orgStudyIdInfo': {'id': '202206027RINA'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'ASD', 'description': 'Diagnosed with DSM-5 autism spectrum disorder', 'interventionNames': ['Other: No intervention involved']}, {'label': 'Clinical', 'description': 'Patients with anxiety, depression, somatic symptoms which are non-psychotic and non-organic', 'interventionNames': ['Other: No intervention involved']}, {'label': 'Control', 'description': 'Healthy control without psychiatric disorder or chronic somatic symptoms', 'interventionNames': ['Other: No intervention involved']}], 'interventions': [{'name': 'No intervention involved', 'type': 'OTHER', 'description': 'No intervention involved', 'armGroupLabels': ['ASD', 'Clinical', 'Control']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}