Ignite Creation Date:
2025-12-24 @ 6:37 PM
Ignite Modification Date:
2025-12-27 @ 2:42 AM
Study NCT ID:
NCT01228357
Status:
UNKNOWN
Last Update Posted:
2015-12-31
First Post:
2010-10-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Predict Antidepressant Responsiveness Using Pharmacogenomics
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, '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': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2003-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-12-30', 'studyFirstSubmitDate': '2010-10-24', 'studyFirstSubmitQcDate': '2010-10-24', 'lastUpdatePostDateStruct': {'date': '2015-12-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-10-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Presences of each individual symptom of depression at 1,2,4,6,12 weeks', 'timeFrame': '12 weeks', 'description': '17-items HAM-D scale was employed to measure depressive symptoms'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Pharmacogenomics', 'Depressed Patients'], 'conditions': ['Depression', 'Depressive Symptoms']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether genetic information associated with individual depressive symptoms.', 'detailedDescription': 'The primary hypothesis is that the variations of the candidate genes are associated with individual symptoms in patients with depression.\n\nThe Second hypothesis is that patients with the associated genetic variation suffer longer from the associated symptom than the patients without the associated genetic variation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '89 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 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.\n* 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\n* received psychotropic medication within 2 weeks of the study or fluoxetine within 4 weeks\n* 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': 'NCT01228357', 'briefTitle': 'Predict Antidepressant Responsiveness Using Pharmacogenomics', 'organization': {'class': 'OTHER', 'fullName': 'Samsung Medical Center'}, 'officialTitle': 'Predict Antidepressant Responsiveness Using Pharmacogenomics', 'orgStudyIdInfo': {'id': '2003-08-07'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SSRI treated group', 'description': 'SSRI treated group is patients treated with fluoxetine, paroxetine, or sertraline', 'interventionNames': ['Drug: SSRI treated group']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'non-SSRI treated group', 'description': 'non-SSRI treated group is patients treated with milnacipran, venlafaxine, nortriptyline, or mirtazapine', 'interventionNames': ['Drug: non-SSRI treated group']}], 'interventions': [{'name': 'SSRI treated group', 'type': 'DRUG', 'otherNames': ['fluoxetine_Prozac', 'paroxetine_Paxil, Seroxat', 'sertraline_Zoloft'], 'description': 'Antidepressant administration of SSRI class for 12 weeks under therapeutic dose', 'armGroupLabels': ['SSRI treated group']}, {'name': 'non-SSRI treated group', 'type': 'DRUG', 'otherNames': ['milnacipran', 'venlafaxine_Effexor', 'nortriptyline_Aventyl, Pamelor, Noritren', 'mirtazapine_Avanza, Zispin, Remeron'], 'description': 'Antidepressant administration of non-SSRI class for 12 weeks under therapeutic dose', 'armGroupLabels': ['non-SSRI treated group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kangnam', 'state': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Doh Kwan Kim, MD.PhD', 'role': 'CONTACT', 'email': 'dohkwan.kim@samsung.com', 'phone': '82-2-3410-3582'}, {'name': 'Woojae Myung, MD.', 'role': 'CONTACT', 'email': 'smbhealer@gmail.com', 'phone': '82-2-3410-6562'}], 'facility': 'Samsung Medical Center'}], 'centralContacts': [{'name': 'JungShil Back, B/Sc.', 'role': 'CONTACT', 'email': 'jungshil.back@sbri.co.kr', 'phone': '82-2-3410-0946'}, {'name': 'Shinn-Won Lim, phD', 'role': 'CONTACT', 'email': 'shinwon.lim@sbri.co.kr', 'phone': '82-2-3410-3759'}], '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., Ph.D.', 'investigatorFullName': 'Doh Kwan Kim', 'investigatorAffiliation': 'Samsung Medical Center'}}}}