Status:
UNKNOWN
Study of Treatment of Depression in Refractory Asthma
Lead Sponsor:
Liam Heaney
Collaborating Sponsors:
Asthma UK
Conditions:
Asthma
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
Purpose and design: The relationship between psychological morbidity and asthma has been previously recognised, however there is little evidence regarding the link between poor mental health and asthm...
Eligibility Criteria
Inclusion
- All patients will be assessed using our well established systematic evaluation protocol. Refractory asthma will be based on the definition of the American Thoracic Society Consensus Workshop, but for the purposes of this study will be defined as follows:
- Persisting symptoms due to asthma (ACS ≥3) despite detailed assessment and management (non-adherence, alternative diagnoses and co-morbidities etc);
- Minimal maintenance therapy of high dose inhaled steroids ( ≥800 mg BDP or equivalent) long acting Beta2-agonist and / or other maintenance therapies (theophylline / leukotriene receptor antagonist).
- The requirement for maintenance oral steroids for ≥ 50% of the year or at least 3 courses of systemic steroids in the preceding 12 months.
- Inclusion criteria:
- Age 18-65 years
- Refractory asthma
- Agreement to take part in trial and to take anti-depressant medication
- Hospital Anxiety and Depression Score ≥11
- Hamilton Depression Rating Scale ≥ 17
Exclusion
- Poor adherence with medication (prescription records, ≤50% of inhaled combination filled in previous 6 months)
- Significant co-morbidity due to conditions other than asthma
- Anti-depressant medication in previous 3 months
- Pregnancy
- Patients requiring non-steroidal anti-inflammatory drugs, aspirin or warfarin
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2012
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01153165
Start Date
November 1 2010
End Date
June 1 2012
Last Update
February 3 2012
Active Locations (1)
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1
Regional Respiratory Centre, Belfast City Hospital
Belfast, United Kingdom, BT9 7AB