Ignite Creation Date:
2025-12-25 @ 2:33 AM
Ignite Modification Date:
2025-12-30 @ 9:47 AM
Study NCT ID:
NCT00785434
Status:
COMPLETED
Last Update Posted:
2010-01-13
First Post:
2008-11-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Escitalopram Doses up to 50mg in Treatment of MDD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003865', 'term': 'Depressive Disorder, Major'}], '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': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-01', 'completionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-01-12', 'studyFirstSubmitDate': '2008-11-04', 'studyFirstSubmitQcDate': '2008-11-04', 'lastUpdatePostDateStruct': {'date': '2010-01-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-11-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The number of patients achieving remission (MADRS<9).', 'timeFrame': '8 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['MDD', 'escitalopram'], 'conditions': ['Major Depressive Disorder']}, 'referencesModule': {'references': [{'pmid': '21410960', 'type': 'DERIVED', 'citation': 'Wade AG, Crawford GM, Yellowlees A. Efficacy, safety and tolerability of escitalopram in doses up to 50 mg in Major Depressive Disorder (MDD): an open-label, pilot study. BMC Psychiatry. 2011 Mar 16;11:42. doi: 10.1186/1471-244X-11-42.'}]}, 'descriptionModule': {'briefSummary': 'This will be an open label study of escitalopram. Patients not responsive to citalopram will be switched directly to escitalopram.\n\nPatients will receive escalating doses of escitalopram up to a maximum of 50 mg until they either achieve remission (MADRS \\<9) or fail to tolerate the dose.', 'detailedDescription': 'Patients will receive escalating doses of escitalopram up to a maximum of 50 mg until they either achieve remission (MADRS \\<9) or fail to tolerate the dose.\n\nVisit 1 - (Initial visit) - escitalopram 10 mg Visit 2 - (Week 2) - escitalopram 20 mg Visit 3 - (Week 4) - review visit Visit 4 - (Week 6) - MADRS \\<12 - continue 20 mg MADRS \\>12 - escitalopram 30 mg Visit 5 - (Week 8) - MADRS \\<8 - continue current dose MADRS \\>8 - escalate dose (20 mg to 30 mg or 30 mg to 35mg)\n\nThereafter, Patients who have achieved remission will be maintained on the remission dosage and reviewed at four weekly intervals. At any subsequent visit where the MADRS is \\>8 they will have a dosage increase\n\nPatients who have not achieved remission will have dosage escalated by 5 mg at two weekly intervals until remission, a maximum dose of 50 mg is achieved or the dosage is intolerable when they will be reduced to the previous tolerable dose.\n\nPatients will be followed up until eight months from their initial visit.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* written informed consent will be obtained from each patient\n* aged 18 to 65 inc\n* suffering from MDD as defined by DSM IV\n* have been taking citalopram in a dose of at least 20mg for at least six weeks\n* an inadequate response -- defined as failure to achieve a MADRS score of \\<12\n\nExclusion Criteria:\n\n* Significant other psychiatric disorder which would interfere with trial assessments. Co-morbid generalized anxiety disorder (GAD) and panic will be permitted where MDD is considered the primary diagnosis .\n* history of mania or bipolar disorder\n* Known contraindication for the use of citalopram or escitalopram.\n* Significant bleeding disorder\n* Prominent suicidal ideation (score more than 4 in the MADRS "suicidal thoughts" item)\n* Alcohol or substance dependence in the past 6 months\n* Major physical illness\n* Significant liver or renal function abnormality\n* Significant ECG abnormalities\n* Pregnant or lactating females\n* Inadequate contraception'}, 'identificationModule': {'nctId': 'NCT00785434', 'briefTitle': 'Efficacy and Safety of Escitalopram Doses up to 50mg in Treatment of MDD', 'organization': {'class': 'OTHER', 'fullName': 'Community Pharmacology Services Ltd'}, 'officialTitle': 'Phase IV Pilot Study to Examine the Efficacy and Safety of Escitalopram in Doses up to 50 mg for the Treatment of Patients With Major Depressive Disorder (MDD).', 'orgStudyIdInfo': {'id': 'CPS/04/2008'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Active', 'description': 'Active escitalopram', 'interventionNames': ['Drug: escitalopram']}], 'interventions': [{'name': 'escitalopram', 'type': 'DRUG', 'description': 'Dose ranging up to 50mg', 'armGroupLabels': ['Active']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'G20 0XA', 'city': 'Glasgow', 'country': 'United Kingdom', 'facility': 'CPS Research', 'geoPoint': {'lat': 55.86515, 'lon': -4.25763}}], 'overallOfficials': [{'name': 'Alan G Wade, MBChB', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CPS Research'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Community Pharmacology Services Ltd', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Dr AG Wade', 'oldOrganization': 'Director, CPS Research'}}}}