Study of Treatment of Depression in Refractory Asthma

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by Belfast Health and Social Care Trust.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Asthma UK
Information provided by (Responsible Party):
Liam Heaney, Belfast Health and Social Care Trust
ClinicalTrials.gov Identifier:
NCT01153165
First received: June 29, 2010
Last updated: February 1, 2012
Last verified: February 2012
  Purpose

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.

Condition Intervention
Asthma
Drug: Citalopram
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pilot Study of Treatment of Depression in Refractory Asthma

Resource links provided by NLM:


Further study details as provided by Belfast Health and Social Care Trust:

Primary Outcome Measures:
  • Improvement in Asthma Control Score [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Improvement in Hamilton Rating Scale for Depression (HDRS) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Improvement in Asthma Quality of Life Questionnaire (AQLQ) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Improvement in Hospital Anxiety and Depression Scale (HADS) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Improvement in Lung function [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Reduction in Fractional exhaled nitric oxide [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Sputum eosinophil count [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Reduction in dose of oral steroids (if applicable) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: November 2010
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Citalopram
Participants will be commenced on Citalopram 20mgs daily
Drug: Citalopram
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
Drug: 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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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 Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01153165

Contacts
Contact: Jacqui Gamble, PhD 0442890263740 ext 2078 jacqui.gamble@belfasttrust.hscni.net
Contact: Liam Heaney, MD 0442890263740 ext 2078 l.heaney@qub.ac.uk

Locations
United Kingdom
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         
Sponsors and Collaborators
Liam Heaney
Asthma UK
  More Information

No publications provided

Responsible Party: Liam Heaney, Consultant Physician, Belfast Health and Social Care Trust
ClinicalTrials.gov Identifier: NCT01153165     History of Changes
Other Study ID Numbers: 10015LH-OPMS
Study First Received: June 29, 2010
Last Updated: February 1, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Belfast Health and Social Care Trust:
Refractory
Asthma
Depression

Additional relevant MeSH terms:
Asthma
Depression
Depressive Disorder
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Behavioral Symptoms
Mood Disorders
Mental Disorders
Citalopram
Dexetimide
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Antiparkinson Agents
Anti-Dyskinesia Agents

ClinicalTrials.gov processed this record on July 31, 2014