Study of Treatment of Depression in Refractory Asthma
Status:
Unknown status
Trial end date:
2012-06-01
Target enrollment:
Participant gender:
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 asthma control in people with severe asthma. If evidence was available
showing that identifying and treating depression, resulted in meaningful improvements in
people's asthma symptoms, this would be helpful in changing doctors' approach to people with
severe asthma, ensuring that both physical and mental wellbeing were considered.
This study will be a double blind randomised placebo controlled pilot study which aims to
identify; if treating depression in patients with well characterised refractory asthma
improves depression and asthma control. Forty patients who meet the inclusion criteria will
be randomised to either a placebo or anti-depressant medication group, neither the
participant nor the researcher will be aware of which medication they are given. Patients
recruited will have severe asthma; will be identified as having depression using two
validated questionnaires and will agree to take part and to take anti-depressant medication.
Patients with poor adherence to medication, other respiratory conditions and who have had
anti-depressant medication in previous the 6 months will be excluded. Outcome measures such
as depression questionnaires, quality of life questionnaire, lung function, measures of
airways inflammation and reduction in dose of oral steroids will be used to determine the
effect of anti-depressant medication on depression and asthma control. The treatment period
will be 12 weeks with outcomes assessed in the first and final week of treatment. The
investigators hope to find out if the study protocol we have devised is feasible for a larger
multi-Centre clinical trial and demonstrate some evidence that treating depression in
subjects with well characterised refractory asthma will improve depression and asthma symptom
control (this will be used to estimate the size of a larger clinical trial).
Recruitment: Participants will be identified and approached by a member of their usual
healthcare team and invited to participate. Participants will be given time to consider
whether they wish to take part and will assured that their care will be unaffected should
they choose not to participate or to withdraw during the study period.
Inclusion/exclusion: 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. Patients recruited will have refractory asthma, will be
identified as having depression using two validated questionnaires and will agree to take
part and to take anti-depressant medication. Patients with poor adherence to medication,
other respiratory conditions and who have had anti-depressant medication in previous the 6
months will be excluded.
Consent: People who are unable to give informed consent will be excluded from the study as
they may be particularly vulnerable. Capacity to give informed consent will be assessed by
the participant's usual healthcare professionals.
Risks, burdens and benefits
There is a small risk of agitation and suicidal ideation associated with commencement of
selective serotonin reuptake inhibition (SSRI) anti-depressants. The investigators will
attempt to minimise this risk by:
1. Contacting participants 1 week after commencing treatment and 1 week after any
subsequent dose increase to ensure there is no suggestion of agitation or suicidal
ideation. This is in accordance with the guidelines for initiation of SSRI therapy in
adults.
2. Participants will also be contacted weekly for 2 weeks after discontinuation of study
treatment. If depressive symptoms worsen patients will be advised to liaise with their
GP to consider institution of treatment on clinical grounds.