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Clinical Trials/EUCTR2010-019360-36-GB
EUCTR2010-019360-36-GB
Active, not recruiting
Not Applicable

Pilot study of treatment of depression in refractory asthma - Treatment of depression in refractory asthma

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Refractory Asthma Depression
Sponsor
Belfast Health and Social Care Trust
Status
Active, not recruiting
Last Updated
13 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
April 16, 2010
End Date
TBD
Last Updated
13 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

Not specified

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