Ignite Creation Date:
2025-12-24 @ 4:21 PM
Ignite Modification Date:
2025-12-26 @ 2:51 PM
Study NCT ID:
NCT00253266
Status:
COMPLETED
Last Update Posted:
2015-04-08
First Post:
2005-11-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Venlafaxine Augmentation in Treatment Resistant Depression
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}, {'id': 'D061218', 'term': 'Depressive Disorder, Treatment-Resistant'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069470', 'term': 'Venlafaxine Hydrochloride'}, {'id': 'D000069348', 'term': 'Quetiapine Fumarate'}], 'ancestors': [{'id': 'D003511', 'term': 'Cyclohexanols'}, {'id': 'D000441', 'term': 'Hexanols'}, {'id': 'D005233', 'term': 'Fatty Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010627', 'term': 'Phenethylamines'}, {'id': 'D005021', 'term': 'Ethylamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D003987', 'term': 'Dibenzothiazepines'}, {'id': 'D013841', 'term': 'Thiazepines'}, {'id': 'D013846', 'term': 'Thiepins'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 126}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-07', 'studyFirstSubmitDate': '2005-11-11', 'studyFirstSubmitQcDate': '2005-11-11', 'lastUpdatePostDateStruct': {'date': '2015-04-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-11-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hamilton Depression Rating Scale (HDRS)', 'timeFrame': 'after monotherapy and after augmentation'}], 'secondaryOutcomes': [{'measure': 'Self reported psychopathology (Beck Depression Inventory [BDI], State-Trait Anxiety Inventory [STAI])', 'timeFrame': 'after monotherapy and after augmentation'}, {'measure': 'Cognitive function', 'timeFrame': 'after monotherapy and after augmentation'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Treatment resistant depression', 'Augmentation', 'Pharmacogenetics'], 'conditions': ['Depression']}, 'descriptionModule': {'briefSummary': 'This is an assessment of the efficacy of venlafaxine-HCL augmentation with the neuroleptic quetiapine in treatment resistant depression.', 'detailedDescription': 'We examine the efficacy of Venlafaxine-HCL augmentation with the neuroleptic Quetiapine in treatment resistant depression in a double-blind randomized clinical trial. Secondary objective is the evaluation of pharmacogenetic factors contributing to drug efficacy in treatment resistant depression.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female and male inpatients with a major depressive disorder without psychotic features or with a depressive episode within a bipolar I or II disorder without psychotic features\n* Ages between 20 and 70 years\n* Total score greater than 18 on the Hamilton Depression Rating Scale\n* Documentation of at least one ineffective antidepressant drug trial under adequate dosage for at least 6 weeks in the current episode\n\nExclusion Criteria:\n\n* Other psychiatric axis I disorders than those mentioned as Inclusion criteria\n* Acute suicidality (Item 3 of the Hamilton Depression Rating Scale greater than 2)\n* Drug or alcohol addiction\n* Patients with severe hepatic, cardiovascular, neurologic, metabolic or malignant disorders\n* Documentation or report of a previous ineffective treatment trial with venlafaxine, lamotrigine or quetiapine\n* Functional kidney disorders\n* Untreated hypertension\n* Acute treatment with thyroid hormone (less than 3 months)\n* Pregnant or nursing patients\n* Women of childbearing age without effective contraception'}, 'identificationModule': {'nctId': 'NCT00253266', 'briefTitle': 'Venlafaxine Augmentation in Treatment Resistant Depression', 'organization': {'class': 'OTHER', 'fullName': 'Max-Planck-Institute of Psychiatry'}, 'officialTitle': 'Comparison of Venlafaxine Augmentation With Quetiapine v.s. Placebo in Treatment Resistant Depression', 'orgStudyIdInfo': {'id': '01/2005'}, 'secondaryIdInfos': [{'id': '2005-001217-17', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Verum', 'description': 'Quetiapine augmentation', 'interventionNames': ['Drug: Venlafaxine', 'Drug: Quetiapine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '"Placebo" augmentation', 'interventionNames': ['Drug: Venlafaxine']}], 'interventions': [{'name': 'Venlafaxine', 'type': 'DRUG', 'otherNames': ['Trevilor retard'], 'description': 'Venlafaxine XR up to 450 mg/d during the complete trial (8 weeks)', 'armGroupLabels': ['Placebo', 'Verum']}, {'name': 'Quetiapine', 'type': 'DRUG', 'otherNames': ['Seroquel'], 'description': 'Quetiapine up to 200 mg/d for four weeks', 'armGroupLabels': ['Verum']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80804', 'city': 'Munich', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'Max Planck Institute of Psychiatry', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}], 'overallOfficials': [{'name': 'Florian Holsboer, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Max-Planck-Institute of Psychiatry'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Max-Planck-Institute of Psychiatry', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}