Study of Treatment of Depression in Refractory Asthma
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|ClinicalTrials.gov Identifier: NCT01153165|
Recruitment Status : Unknown
Verified February 2012 by Liam Heaney, Belfast Health and Social Care Trust.
Recruitment status was: Recruiting
First Posted : June 30, 2010
Last Update Posted : February 3, 2012
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:
- 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.
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Asthma||Drug: Citalopram Drug: Placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Pilot Study of Treatment of Depression in Refractory Asthma|
|Study Start Date :||November 2010|
|Estimated Primary Completion Date :||June 2012|
|Estimated Study Completion Date :||June 2012|
Participants will be commenced on Citalopram 20mgs daily
Participants will be commenced on Citalopram 20mgs daily. At week 4 participants will be assessed for response to treatment . If no response, dose of Citalopram will be increased to 40mgs for the remaining 8 weeks of the study. Patients who respond will remain on 20mgs for remaining 8 weeks.
Placebo Comparator: Control
Control group - will receive a matched placebo
Participants in the control group will receive a matched placebo. At week 4 participants will be assessed for response to treatment. If no response, dose of placebo will be increased to 40mgs for the remaining 8 weeks of the study. Patients who respond will remain on 20mgs for remaining 8 weeks.
- Improvement in Asthma Control Score [ Time Frame: 12 weeks ]
- Improvement in Hamilton Rating Scale for Depression (HDRS) [ Time Frame: 12 weeks ]
- Improvement in Asthma Quality of Life Questionnaire (AQLQ) [ Time Frame: 12 weeks ]
- Improvement in Hospital Anxiety and Depression Scale (HADS) [ Time Frame: 12 weeks ]
- Improvement in Lung function [ Time Frame: 12 weeks ]
- Reduction in Fractional exhaled nitric oxide [ Time Frame: 12 weeks ]
- Sputum eosinophil count [ Time Frame: 12 weeks ]
- Reduction in dose of oral steroids (if applicable) [ Time Frame: 12 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01153165
|Contact: Jacqui Gamble, PhD||0442890263740 ext email@example.com|
|Contact: Liam Heaney, MD||0442890263740 ext firstname.lastname@example.org|
|Regional Respiratory Centre, Belfast City Hospital||Recruiting|
|Belfast, United Kingdom, BT9 7AB|
|Contact: Jacqui Gamble, PhD|
|Contact: Liam Heaney, MD|
|Principal Investigator: Liam Heaney, MD|
|Sub-Investigator: Jacqui Gamble, PhD|