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Escitalopram in Anxiety Associated Chronic Obstructive Pulmonary Disease (COPD) Exacerbations

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01522092
Recruitment Status : Withdrawn (Study was not given ethical approval- a alternative protocol required)
First Posted : January 31, 2012
Last Update Posted : March 29, 2017
Information provided by (Responsible Party):
Prof A H Morice, Hull University Teaching Hospitals NHS Trust

Brief Summary:

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.

Our 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.

Condition or disease Intervention/treatment Phase
Anxiety COPD Drug: escitalopram Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Escitalopram on Exacerbation Rates and Quality of Life in Patients With Anxiety Associated With Severe COPD

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: escitalopram
escitalipram tablets 5mg, 10 mg and 20 mg, once a day for 12 months
Drug: escitalopram
5mg-20mg, tablet, od, 12 months
Other Name: Cipralex

Primary Outcome Measures :
  1. exacerbation rate [ Time Frame: 12 months ]
    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.

Secondary Outcome Measures :
  1. Quality of life [ Time Frame: 12 months ]
    To assess the effect of escitalopram on the patient's quality of life, as measured by St Georges Respiratory Questionnaire

  2. Hospital Anxiety and depression scale (HADS) [ Time Frame: 12 months ]
    Change in HADS score at 3, 9, and 12 months from baseline

  3. General anxiety disorder(GAD-7) [ Time Frame: 12 months ]
    Change in GAD-7 score at 3,9 and 12 months from baseline

  4. Modified Medical Research Council (MMRC) dyspnoea scale [ Time Frame: 12 month ]
    Change in Modified Medical research council Dyspnoea scale at 3, 9 and 12 months from baseline

  5. BODE index [ Time Frame: 12 months ]
    Change in BODE index at 3, 9 and 12months from baseline

  6. Health related utilisation [ Time Frame: 12 months ]
    Number of health related utilisations from baseline to 3, 9 and 12 months

  7. Spirometry [ Time Frame: 12 months ]
    Change in Forced expired volume in 1 sec, Forced vital capacity and Peak expiratory flow measured at 3, 9 and 12 months from baseline

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Male/females aged between 40-80 years.
  • Previous diagnosis of COPD confirmed by the GOLD criteria.
  • At least two previous admissions to hospital for acute exacerbation of COPD.
  • Physician diagnosed anxiety
  • At least Mild anxiety score on HADS and GAD-7
  • On a stable therapeutic regimen for COPD for 8 weeks prior to inclusion
  • Known history of cigarette smoking at least 10 pack yrs
  • Willing and able to comply with study procedures
  • Able to provide written informed consent to participate

Exclusion Criteria:

  • Current or past diagnosis of asthma
  • Long-term oxygen therapy
  • Currently on treatment with anti-depressives
  • Serious inter-current illness (eg lung cancer)
  • One year survival considered unlikely
  • Patients who have evidence of alcohol or drug abuse
  • Participation in another clinical trial with an investigational drug in four weeks preceding the screening visit
  • Clinically significant or unstable concurrent disease e.g. left ventricular failure, diabetes mellitus
  • Known or suspected hypersensitivity to escitalopram

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01522092

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United Kingdom
Respiratory Medicine, Clinical trials Unit, Castle Hill Hospital
Cottingham, East Yorkshire, United Kingdom, HU16 5JQ
Sponsors and Collaborators
Hull University Teaching Hospitals NHS Trust
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Principal Investigator: Alyn H Morice, Professor Hull University Teaching Hospitals NHS Trust
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Responsible Party: Prof A H Morice, professor of Respiratory Medicine, Hull University Teaching Hospitals NHS Trust Identifier: NCT01522092    
Other Study ID Numbers: Escit160710
2010-022038-10 ( EudraCT Number )
First Posted: January 31, 2012    Key Record Dates
Last Update Posted: March 29, 2017
Last Verified: March 2017
Keywords provided by Prof A H Morice, Hull University Teaching Hospitals NHS Trust:
Additional relevant MeSH terms:
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Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Serotonin Agents
Anxiety Disorders
Mental Disorders
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs