Ignite Creation Date:
2025-12-25 @ 2:54 AM
Ignite Modification Date:
2025-12-26 @ 1:35 AM
Study NCT ID:
NCT00263133
Status:
COMPLETED
Last Update Posted:
2007-06-04
First Post:
2005-12-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Modulation of Visually Evoked Potentials by an Antidepressant
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': 'D020280', 'term': 'Sertraline'}], 'ancestors': [{'id': 'D015057', 'term': '1-Naphthylamine'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-05', 'completionDateStruct': {'date': '2006-01'}, 'lastUpdateSubmitDate': '2007-06-01', 'studyFirstSubmitDate': '2005-12-06', 'studyFirstSubmitQcDate': '2005-12-06', 'lastUpdatePostDateStruct': {'date': '2007-06-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-12-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Amplitudes and latencies of early visually evoked potentials.'}]}, 'conditionsModule': {'keywords': ['Depression', 'SSRI', 'Sertraline', 'synaptic plasticity', 'visually evoked potentials'], 'conditions': ['Depression']}, 'descriptionModule': {'briefSummary': '12 normal healthy controls will be treated with 50 mg sertraline once daily for three weeks. Early amplitudes of visually evoked potentials will be examined at day 0, 10 and 21 and statistically compared. This study aims to examine a putative modulation of synaptic transmission and plasticity by an antidepressant and is part of a series of studies in healthy individuals and depressed patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy individuals 18-65 years\n\nExclusion Criteria:\n\n* history of affective oder other psyhiatric disorder\n* severe medical condition\n* pregnancy or ineffective contraception\n* active illicit drug use'}, 'identificationModule': {'nctId': 'NCT00263133', 'briefTitle': 'Modulation of Visually Evoked Potentials by an Antidepressant', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Freiburg'}, 'officialTitle': 'Modulation of Visually Evoked Potentials by an Antidepressant', 'orgStudyIdInfo': {'id': 'VEP-1'}, 'secondaryIdInfos': [{'id': 'EudraCT 2005-005417-37'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Sertraline', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '79104', 'city': 'Freiburg im Breisgau', 'country': 'Germany', 'facility': 'Dept. of Psychiatry, University of Freiburg', 'geoPoint': {'lat': 47.9959, 'lon': 7.85222}}], 'overallOfficials': [{'name': 'Claus Normann, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dept. of Psychiatry, University of Freiburg'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Freiburg', 'class': 'OTHER'}}}}