Ignite Creation Date:
2025-12-24 @ 7:10 PM
Ignite Modification Date:
2026-02-20 @ 3:57 PM
Study NCT ID:
NCT01477203
Status:
COMPLETED
Last Update Posted:
2016-09-14
First Post:
2011-11-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multimodal Assessment of Neurobiological Markers for Psychiatric Disorders
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003865', 'term': 'Depressive Disorder, Major'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000089983', 'term': 'Escitalopram'}], 'ancestors': [{'id': 'D011437', 'term': 'Propylamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D009570', 'term': 'Nitriles'}, {'id': 'D001572', 'term': 'Benzofurans'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 289}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-09-13', 'studyFirstSubmitDate': '2011-11-15', 'studyFirstSubmitQcDate': '2011-11-18', 'lastUpdatePostDateStruct': {'date': '2016-09-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-11-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'SSRI induced changes in BOLD (blood oxygen level dependent) response over time', 'timeFrame': '4 vears'}, {'measure': 'SSRI induced changes in ERPs (event-related potentials) over time', 'timeFrame': '4 years'}], 'secondaryOutcomes': [{'measure': 'biochemical data', 'timeFrame': '4 years', 'description': 'these include steroid hormone levels, vitamins, etc.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Major Depressive Disorder (MDD)', 'Anxiety Disorder']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.meduniwien.ac.at/neuroimaging/', 'label': 'Related Info'}, {'url': 'http://biol-psy.univie.ac.at/', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'MAN-BIOPSY pursues the concrete research question whether novel biological and psycho-physiological clusters or categories can be defined to improve treatment and minimize side effects in psychiatry, based on a synopsis of physiological, behavioural, genetic and endocrinological parameters. One major aspect of our research approach is its focuses on the identification of dysfunctions in fundamental information processing mechanisms and neurocomputational mechanisms, and is not restricted to symptom-oriented tasks.\n\nThe main objectives of MAN-BIOPSY are therefore\n\n* to identify biological and psycho-physiological parameters for major depressive disorders and anxiety disorders, and\n* to identify predictive markers for treatment response and type/severity of side effects for these disorders.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria for patients:\n\n* DSM-IV-TR diagnosis of MDD or an anxiety disorder (excluding PTSD, specific phobias, and bipolar disorder) by a structured clinical interview (SCID)\n* aged 18 to 50 years\n* drug-free within the last three months prior inclusion\n* willingness and competence to sign the informed consent form\n\nInclusion Criteria for remitted subjects:\n\n* a previous DSM-IV-TR diagnosis of MDD or an anxiety disorder (excluding PTSD, specific phobias, and bipolar disorder) but no symptoms at present, determined by SCID\n* aged 18-50 years\n* drug-free within the last three months prior inclusion\n* willingness and competence to sign the informed consent form\n\nInclusion Criteria for healthy control subjects:\n\n* Inclusion criteria for healthy control subjects are\n* willingness and competence to sign the informed consent form\n* aged 18-50 years\n* drug-free\n\nExclusion Criteria:\n\n* concomitant major internal or neurological illness\n* concomitant psychiatric disorders (except depression and anxiety for patients, excluding PTSD, claustrophobia and bipolar disorder)\n* ingestion of any antipsychotic, antidepressant, or anti-anxiety agent within the last three months prior to the screening visit\n* current substance abuse\n* failure to comply with the study protocol or to follow the instructions of the investigating team'}, 'identificationModule': {'nctId': 'NCT01477203', 'acronym': 'MAN-BIOPSY', 'briefTitle': 'Multimodal Assessment of Neurobiological Markers for Psychiatric Disorders', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Vienna'}, 'officialTitle': 'Multimodal Assessment of Neurobiological Markers for Psychiatric Disorders', 'orgStudyIdInfo': {'id': 'FA103FC001'}, 'secondaryIdInfos': [{'id': '2011-004860-31', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Escitalopram', 'description': '50 Major Depressive Disorder Patients and 50 Anxiety Disorder Patients will receive Escitalopram as medication', 'interventionNames': ['Drug: Escitalopram']}, {'type': 'NO_INTERVENTION', 'label': 'Remitted Patients'}, {'type': 'NO_INTERVENTION', 'label': 'Healthy Controls'}], 'interventions': [{'name': 'Escitalopram', 'type': 'DRUG', 'description': '2-4 weeks, 5-10mg, max 20mg', 'armGroupLabels': ['Escitalopram']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1090', 'city': 'Vienna', 'state': 'Vienna', 'country': 'Austria', 'facility': 'Medical University of Vienna, Department for Psychiatrie and Psychotherapie', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Vienna', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'A/Prof.PD.Dr.', 'investigatorFullName': 'Rupert Lanzenberger', 'investigatorAffiliation': 'Medical University of Vienna'}}}}