Pilot study of treatment of depression in refractory asthma - Treatment of depression in refractory asthma
- Conditions
- Refractory Asthma Depression
- Registration Number
- EUCTR2010-019360-36-GB
- Lead Sponsor
- Belfast Health and Social Care Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
1. Refractory asthma as defined by persisting symptoms due to asthma (Asthma control score =3), despite detailed assessment and management of alternative diagnoses, non-adherence, co-morbidites etc. Minimal maintenance therapy of high dose inhaled steroids (=800mcg BDP or equivalent), long acting beta-agonist and/or other maintenance therapies. The requirement for maintenance steroids for =50% of the year or at least 3 courses of systemic steroids in preceding 12 months. 2. Hosptial Anxiety Depression Scale of =11 and Hamiliton Rating scale =17.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0
1. Poor medication adherence 2. Significant co-morbidity due to condition other than asthma 3. Anti-depressant medication in previous 3 months 4. Pregnancy 5. Patients requiring NSAID’s, aspirin or warfarin 6. Patients with reduced hepatic function 7. Patients with any history of cardiac disease 8. Patients with congenital long QT syndrome or known pre-existing QT interval prolongation taking other medicines known to prolong QT interval. 9. Patients with pre-existing risk factors for QT interval prolongation, including patients with significant bradycardia, recent acute myocardial infarction or decompensated heart failure. 10. Patients with electrolyte disturbances (eg, hypokalaemia and hypomagnesaemia). 11. Patients taking concomitant medications known to increase plasma levels of citalopram such as: - some antiretroviral medications - omeprazole - cimetidine
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The prinipal research question is 'Does treating depression in patients with refractory asthma improve depression and asthma control?';Secondary Objective: ;Primary end point(s): To measure improvement in asthma control and depression two outcomes will be assessed: Asthma control Score and Hamilton Rating Scale for Depression
- Secondary Outcome Measures
Name Time Method