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Trial record 52 of 589 for:    ESCITALOPRAM AND Celexa

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

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ClinicalTrials.gov 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Recruitment Status : Withdrawn (Study was not given ethical approval- a alternative protocol required)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
Sponsor:
Information provided by (Responsible Party):
Prof A H Morice, Hull and East Yorkshire Hospitals NHS Trust

Tracking Information
First Submitted Date  ICMJE January 27, 2012
First Posted Date  ICMJE January 31, 2012
Last Update Posted Date March 29, 2017
Study Start Date  ICMJE Not Provided
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: January 30, 2012)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01522092 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 16, 2014)
  • 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
  • Hospital Anxiety and depression scale (HADS) [ Time Frame: 12 months ]
    Change in HADS score at 3, 9, and 12 months from baseline
  • General anxiety disorder(GAD-7) [ Time Frame: 12 months ]
    Change in GAD-7 score at 3,9 and 12 months from baseline
  • 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
  • BODE index [ Time Frame: 12 months ]
    Change in BODE index at 3, 9 and 12months from baseline
  • Health related utilisation [ Time Frame: 12 months ]
    Number of health related utilisations from baseline to 3, 9 and 12 months
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: January 30, 2012)
  • 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
  • Hospital Anxiety and depression scale (HADS) [ Time Frame: 12 months ]
    Change in HADS score at 3, 9, and 12 months from baseline
  • General anxiety disorder(GAD-7) [ Time Frame: 12 months ]
    Change in GAD-7 score at 3,9 and 12 months from baseline
  • 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
  • BODE index [ Time Frame: 12 months ]
    Change in BODE index at 3, 9 and 12months from baseline
  • Health related utilisation [ Time Frame: 12 months ]
    Number of health related utilisations from baseline to 3, 9 and 12 months
  • Spirometry [ Time Frame: 12 months ]
    Change in FEV1, FVC and PEF measured at 3, 9 and 12 months from baseline
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Escitalopram in Anxiety Associated Chronic Obstructive Pulmonary Disease (COPD) Exacerbations
Official Title  ICMJE The Effect of Escitalopram on Exacerbation Rates and Quality of Life in Patients With Anxiety Associated With Severe COPD
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Anxiety
  • COPD
Intervention  ICMJE Drug: escitalopram
5mg-20mg, tablet, od, 12 months
Other Name: Cipralex
Study Arms  ICMJE Experimental: escitalopram
escitalipram tablets 5mg, 10 mg and 20 mg, once a day for 12 months
Intervention: Drug: escitalopram
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: February 19, 2016)
0
Original Estimated Enrollment  ICMJE
 (submitted: January 30, 2012)
30
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01522092
Other Study ID Numbers  ICMJE Escit160710
2010-022038-10 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Prof A H Morice, Hull and East Yorkshire Hospitals NHS Trust
Study Sponsor  ICMJE Hull and East Yorkshire Hospitals NHS Trust
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Alyn H Morice, Professor Hull and East Yorkshire Hospitals NHS Trust
PRS Account Hull and East Yorkshire Hospitals NHS Trust
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP