Ignite Creation Date:
2025-12-24 @ 9:34 PM
Ignite Modification Date:
2025-12-25 @ 7:18 PM
Study NCT ID:
NCT00145132
Status:
COMPLETED
Last Update Posted:
2010-06-02
First Post:
2005-09-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Beta-CIT-SPECT and Neurophysiology in Depression
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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-05', 'completionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-06-01', 'studyFirstSubmitDate': '2005-09-01', 'studyFirstSubmitQcDate': '2005-09-01', 'lastUpdatePostDateStruct': {'date': '2010-06-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'changes in β-CIT/neurophysiological measurements from baseline to week 4', 'timeFrame': 'two assessments, at baseline and week 4'}]}, 'conditionsModule': {'keywords': ['depression', 'β-CIT-SPECT', 'SERT', 'DAT', 'neurophysiology', 'LDAEP', 'escitalopram', 'SSRI'], 'conditions': ['Depression']}, 'descriptionModule': {'briefSummary': 'Aim of this project is to investigate the effects of escitalopram on monoamine transporter (SERT, DAT) availabilities as assessed by b-CIT and SPECT, and on neurophysiological parameters such as the loudness dependence of auditory evoked potentials (LDAEP) in patients with depression.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Psychiatric in or outpatients with acute depressive episode\n* Indication for pharmacological treatment\n\nExclusion Criteria:\n\n* Acute suicidality\n* Neurological or severe somatic disorders\n* Occupational exposition to radiation \\>15 mSv per year\n* Women during pregnancy or lactation'}, 'identificationModule': {'nctId': 'NCT00145132', 'briefTitle': 'Beta-CIT-SPECT and Neurophysiology in Depression', 'organization': {'class': 'OTHER', 'fullName': 'Ludwig-Maximilians - University of Munich'}, 'officialTitle': 'Serotonin and Dopamine Transporter (SERT, DAT) Availabilities as Assessed by b-CIT and SPECT, and Neurophysiological Measures of Central Serotonergic Activity in Patients With Depression Under Treatment With Escitalopram', 'orgStudyIdInfo': {'id': 'ESCIT-SPECT-Pogarell'}, 'secondaryIdInfos': [{'id': 'EK287/98'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'β-CIT-SPECT, Neurophysiology', 'type': 'PROCEDURE', 'description': 'β-CIT-SPECT scans and EEG recordings, two assessments each'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'D-80336', 'city': 'Munich', 'country': 'Germany', 'facility': 'Depts. of Psychiatry and Nuclear Medicine, Ludwig-Maximilians-University of Munich', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}], 'overallOfficials': [{'name': 'Oliver Pogarell, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dept. of Psychiatry, University of Munich'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ludwig-Maximilians - University of Munich', 'class': 'OTHER'}, 'collaborators': [{'name': 'H. Lundbeck A/S', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Oliver Pogarell, MD', 'oldOrganization': 'University of Munich'}}}}