Ignite Creation Date:
2025-12-24 @ 3:01 PM
Ignite Modification Date:
2025-12-26 @ 9:00 PM
Study NCT ID:
NCT01352559
Status:
UNKNOWN
Last Update Posted:
2015-12-31
First Post:
2011-04-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prediction of Antidepressant Response Using Pharmacogenetics and Peripheral Lymphocytic Phenotype
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}, {'id': 'D064420', 'term': 'Drug-Related Side Effects and Adverse Reactions'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017374', 'term': 'Paroxetine'}, {'id': 'D000078764', 'term': 'Milnacipran'}, {'id': 'D009661', 'term': 'Nortriptyline'}, {'id': 'D000078785', 'term': 'Mirtazapine'}], 'ancestors': [{'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003521', 'term': 'Cyclopropanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D003986', 'term': 'Dibenzocycloheptenes'}, {'id': 'D001567', 'term': 'Benzocycloheptenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D003984', 'term': 'Dibenzazepines'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2001-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-12-30', 'studyFirstSubmitDate': '2011-04-21', 'studyFirstSubmitQcDate': '2011-05-11', 'lastUpdatePostDateStruct': {'date': '2015-12-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-05-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Antidepressant Response at 6 weeks', 'timeFrame': '6 weeks', 'description': 'antidepressant response is defined as the decrease rate of HAM-D score for 6week was = or \\> 50%\n\nMeasurement Unit = responders, nonresponders'}], 'secondaryOutcomes': [{'measure': 'Biological value at 0 and 6 weeks', 'timeFrame': '6 weeks', 'description': 'Biological value is defined as\n\n1. Genetic information of bioamine transporter genes of patients. Measurement unit = if it is SNP,it is A, T, G, or C, and if VNTR, short or long allele\n\n or\n2. Biological measure value of patients at 0 and 6week after antidepressant treatment(ex. peripheral markers such as serum BDNF, CREB...).\n\nMeasurement unit = numerical value and thier unit such as O.D.(Optical Density)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Pharmacogenomics', 'Prediction of Antidepressant Response', 'Depressed Patients', 'biomarkers', 'phenotype', 'Antidepressant Response', 'Adverse Reaction to Drug'], 'conditions': ['Depression']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether pharmacogenomic study of bioamine transporters and peripheral lymphatic biomarkers(phenotype) predict antidepressant responsiveness in advance before the appearance of the drug effects until 4\\~6 weeks after drug administration.', 'detailedDescription': 'The purpose of this study is to determine whether genomic effects or peripheral lymphatic biomarkers on antidepressant response differed by class of drug, whether genomic and biomarker differences between drug responders and nonresponders predict the response of antidepressant and to construct the prediction model for antidepressant treatment in order to aid to select the their genetically or endophenotypic matching drugs.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '89 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. eligible patients were enrolled in the clinical trials program of hte Samsung Medical Center Geropsychiatry and Affective Disorder Clinics(Seoul, Korea). They received a semistructured diagnostic interview, the Samsung Psychiatric Evaluation Schedule. The affective disorder section of the Samsung Psychiatric Evaluation Schedule uses the Korean version of the structured clinical interview for the diagnostic and statistical manual of mental disorders, Fourth edition.\n2. interview with one more patient's family member for objective diagnosis and final diagnosis decision by agreements of two more psychiatric physicians\n\nExclusion Criteria:\n\n1. received psychotropic medication within 2 weeks of the study or fluoxetine within 4 weeks\n2. potential study participants for pregnancy, significant medical conditions, abnormal laboratory baseline values, unstable psychiatric features(eg.suicidal), history of alcohol of drug dependence, seizures, head trauma with loss of consciousness, neurological illness, or concomitant Axis I psychiatric disorder."}, 'identificationModule': {'nctId': 'NCT01352559', 'briefTitle': 'Prediction of Antidepressant Response Using Pharmacogenetics and Peripheral Lymphocytic Phenotype', 'organization': {'class': 'OTHER', 'fullName': 'Samsung Medical Center'}, 'officialTitle': 'Prediction of Antidepressant Response Using Pharmacogenetics of Bioamine Transporter and Peripheral Lymphocytic Phenotype', 'orgStudyIdInfo': {'id': '2001-11-03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'responders', 'description': '50 ≤ Decrease rate(%) of HAM-D score', 'interventionNames': ['Drug: responders']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'non-responders', 'description': 'nonresponders is a patients having 50 \\> Decrease rate(%) of HAM-D score', 'interventionNames': ['Drug: non-responders']}], 'interventions': [{'name': 'responders', 'type': 'DRUG', 'otherNames': ['fluoxetine_Prozac', 'paroxetine_Paxil, Seroxat', 'sertraline_Zoloft', 'milnacipran', 'venlafaxine_Effexor', 'nortriptyline_Aventyl, Pamelor, Noritren', 'mirtazapine_Avanza, Zispin, Remeron'], 'description': 'Antidepressants administration for 6 weeks under therapeutic dose', 'armGroupLabels': ['responders']}, {'name': 'non-responders', 'type': 'DRUG', 'otherNames': ['SSRI nonresponders'], 'description': 'Antidepressants administration for 6 weeks under therapeutic dose', 'armGroupLabels': ['non-responders']}]}, 'contactsLocationsModule': {'locations': [{'zip': '135-710', 'city': 'Kangnam', 'state': 'Seoul', 'country': 'South Korea', 'facility': 'Samsung Medical Center'}], 'overallOfficials': [{'name': 'Doh Kwan Kim, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Samsung Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Samsung Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D., pHD', 'investigatorFullName': 'Doh Kwan Kim', 'investigatorAffiliation': 'Samsung Medical Center'}}}}