Ignite Creation Date:
2025-12-24 @ 3:57 PM
Ignite Modification Date:
2026-01-01 @ 8:26 AM
Study NCT ID:
NCT01522092
Status:
WITHDRAWN
Last Update Posted:
2017-03-29
First Post:
2012-01-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Escitalopram in Anxiety Associated Chronic Obstructive Pulmonary Disease (COPD) Exacerbations
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000089983', 'term': 'Escitalopram'}, {'id': 'D003909', 'term': 'Dexetimide'}], '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'}, {'id': 'D010881', 'term': 'Piperidones'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Study was not given ethical approval- a alternative protocol required', 'overallStatus': 'WITHDRAWN', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'lastUpdateSubmitDate': '2017-03-28', 'studyFirstSubmitDate': '2012-01-27', 'studyFirstSubmitQcDate': '2012-01-30', 'lastUpdatePostDateStruct': {'date': '2017-03-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'exacerbation rate', 'timeFrame': '12 months', 'description': 'comparison of the rate of COPD exacerbation in the year preceding treatment with that on escitalopram treatment in patients with COPD adjudged to have a significant element of anxiety.'}], 'secondaryOutcomes': [{'measure': 'Quality of life', 'timeFrame': '12 months', 'description': "To assess the effect of escitalopram on the patient's quality of life, as measured by St Georges Respiratory Questionnaire"}, {'measure': 'Hospital Anxiety and depression scale (HADS)', 'timeFrame': '12 months', 'description': 'Change in HADS score at 3, 9, and 12 months from baseline'}, {'measure': 'General anxiety disorder(GAD-7)', 'timeFrame': '12 months', 'description': 'Change in GAD-7 score at 3,9 and 12 months from baseline'}, {'measure': 'Modified Medical Research Council (MMRC) dyspnoea scale', 'timeFrame': '12 month', 'description': 'Change in Modified Medical research council Dyspnoea scale at 3, 9 and 12 months from baseline'}, {'measure': 'BODE index', 'timeFrame': '12 months', 'description': 'Change in BODE index at 3, 9 and 12months from baseline'}, {'measure': 'Health related utilisation', 'timeFrame': '12 months', 'description': 'Number of health related utilisations from baseline to 3, 9 and 12 months'}, {'measure': 'Spirometry', 'timeFrame': '12 months', 'description': 'Change in Forced expired volume in 1 sec, Forced vital capacity and Peak expiratory flow measured at 3, 9 and 12 months from baseline'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Exacerbations'], 'conditions': ['Anxiety', 'COPD']}, 'descriptionModule': {'briefSummary': 'Anxiety and depression are common in patients with severe chronic obstructive pulmonary disease (COPD). Frequently exacerbation\'s of breathlessness are associated with panic/fear and indeed this may be the main cause for the for hospital admission. Patients prone to a tendency to experience and communicate somatic distress in response to psychosocial stress and to seek medical help for it are top of the "frequent flyer" league, costing the health care economy dearly. This is a particular problem in Hull with the high levels of smoking and urban deprivation combining to place the city at the bottom of the Department of Health COPD league tables.\n\nOur hypothesis is that an effective treatment for anxiety will reduce the number of episodes of hospital admission by reducing the panic/fear element of mild COPD exacerbation\'s thus allowing the patient time to access the existing community based support services.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male/females aged between 40-80 years.\n* Previous diagnosis of COPD confirmed by the GOLD criteria.\n* At least two previous admissions to hospital for acute exacerbation of COPD.\n* Physician diagnosed anxiety\n* At least Mild anxiety score on HADS and GAD-7\n* On a stable therapeutic regimen for COPD for 8 weeks prior to inclusion\n* Known history of cigarette smoking at least 10 pack yrs\n* Willing and able to comply with study procedures\n* Able to provide written informed consent to participate\n\nExclusion Criteria:\n\n* Current or past diagnosis of asthma\n* Long-term oxygen therapy\n* Currently on treatment with anti-depressives\n* Serious inter-current illness (eg lung cancer)\n* One year survival considered unlikely\n* Patients who have evidence of alcohol or drug abuse\n* Participation in another clinical trial with an investigational drug in four weeks preceding the screening visit\n* Clinically significant or unstable concurrent disease e.g. left ventricular failure, diabetes mellitus\n* Known or suspected hypersensitivity to escitalopram'}, 'identificationModule': {'nctId': 'NCT01522092', 'briefTitle': 'Escitalopram in Anxiety Associated Chronic Obstructive Pulmonary Disease (COPD) Exacerbations', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Hull University Teaching Hospitals NHS Trust'}, 'officialTitle': 'The Effect of Escitalopram on Exacerbation Rates and Quality of Life in Patients With Anxiety Associated With Severe COPD', 'orgStudyIdInfo': {'id': 'Escit160710'}, 'secondaryIdInfos': [{'id': '2010-022038-10', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'escitalopram', 'description': 'escitalipram tablets 5mg, 10 mg and 20 mg, once a day for 12 months', 'interventionNames': ['Drug: escitalopram']}], 'interventions': [{'name': 'escitalopram', 'type': 'DRUG', 'otherNames': ['Cipralex'], 'description': '5mg-20mg, tablet, od, 12 months', 'armGroupLabels': ['escitalopram']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'HU16 5JQ', 'city': 'Cottingham', 'state': 'East Yorkshire', 'country': 'United Kingdom', 'facility': 'Respiratory Medicine, Clinical trials Unit, Castle Hill Hospital', 'geoPoint': {'lat': 52.50243, 'lon': -0.7554}}], 'overallOfficials': [{'name': 'Alyn H Morice, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hull University Teaching Hospitals NHS Trust'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hull University Teaching Hospitals NHS Trust', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor of Respiratory Medicine', 'investigatorFullName': 'Prof A H Morice', 'investigatorAffiliation': 'Hull University Teaching Hospitals NHS Trust'}}}}