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ISRCTN
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ISRCTN41544517
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ClinicalTrials.gov identifier
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Public title
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Effect of Citalopram on Health status, anxiety and depression in patients with chronic Obstructive pulmonary disease: a pilot study
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Scientific title
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Acronym
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ECHO
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Serial number at source
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N/A
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Study hypothesis
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Chronic obstructive pulmonary disease (COPD) sufferers often experience a vicious circle of breathlessness and anxiety. These symptoms commonly lead to reduced physical activity, progressive loss of fitness, increasing social isolation and depression (which often goes undiagnosed). If this circle could be broken improved physical functioning and quality of life might result.
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Ethics approval
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Approval was granted by the North Wales Health Authority Research Ethics Committee in a letter dated 5th February 2003 following a meeting on the 22nd January 2003 of the LREC North East Wales.
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Study design
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Randomised controlled, single-centre trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Chronic obstructive pulmonary disease (COPD)
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Participants - inclusion criteria
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1. Diagnosis of COPD
2. Clinical diagnosis of anxiety or depression
3. Adults of either sex
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Participants - exclusion criteria
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1. Severe ischaemic heart disease
2. On treatment for anxiety or depression
3. Terminal illness
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Anticipated start date
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01/08/2003
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Anticipated end date
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01/08/2004
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Status of trial
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Completed
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Patient information material
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Target number of participants
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20
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Interventions
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Matching oral citalopram 20 mg and placebo, starting with half a tablet once per day for two weeks, then one tablet per day for the remaining weeks with monthly follow up for three months and a two week period of half a tablet per day prior to discontinuation of treatment.
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Primary outcome measure(s)
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Health related quality of life measured using St Georges Respiratory Questionnaire, measured at baseline and at three months.
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Secondary outcome measure(s)
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1. Depression and anxiety measured using the Hospital Anxiety and Depression Score (HADS), measured at baseline and at three months
2. Depression, anxiety measured using the Depression in Medical Illness, a 10-item questionnaire (DM-10), measured at baseline and at three months
Additionally at baseline, one month, two months and three months a structured side effect profile was checked.
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Sources of funding
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North East Wales NHS Trust (UK) - Research and Development Fund
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Trial website
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Publications
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Contact name
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Dr
Christian P
Subbe
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Address
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77 Brook Lane
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City/town
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Chester
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Zip/Postcode
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LL13 7TD
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Country
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United Kingdom
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Tel
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+44 (0)1978 291100
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Email
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csubbe@hotmail.com
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Sponsor
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North East Wales NHS Trust (UK)
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Address
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Wrexham Maelor Hospital
Croesnewydd Road
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City/town
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Wrexham
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Zip/Postcode
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LL13 7TD
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Country
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United Kingdom
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Tel
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+44 (0)1978 291100
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Email
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csubbe@hotmail.com
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Sponsor website:
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http://www.newalesnhstrust.org.uk/
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Date applied
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07/08/2007
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Last edited
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21/04/2008
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Date ISRCTN assigned
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21/04/2008
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