None listed
Conditions
Brief summary
An association between increased dyspnoea scores, mood disorders and anxiety levels in patients with COPD has been well established. On a neurochemical level, this association has been further explained in rat models showing that prolonged hypoxia affects the areas of the brain involved in mood control. The understanding of mechanisms of mood control by antidepressants has evolved over time. The strong antidepressant activity of Tricyclic Antidepressants (TCAs) has supported the role of both norepinephrine and serotonin (5-HT) in mood disorders. The next generation of antidepressants included the Selective Serotonin Reuptake Inhibitos (SSRIs), further supporting the role of serotonin. Furthermore, antidepressants have been hypothesised to work in COPD patients by decreasing autonomic over-activity, or detaching excessive distress associated with COPD, thus enabling patients to better endure increased physical activity and physiological changes. Hence, our hypothesis is that subjects recruited from public hospitals with COPD and clinically significant depression and/or anxiety that are given paroxetine 20 mgs daily for 4 months will: (Hypothesis 1: principle hypothesis): have a significant reduction in their anxiety symptoms as compared with the placebo at 4 months follow-up, and; (Hypothesis 2): these improved levels of anxiety will be associated with: improved quality of life and exercise capacity, and (Hypothesis 3): these improved levels of anxiety will be associated with: a.) a reduction in hospital bed utilisation, and; b.) a reduction in health care costs in relation to existing practice in long term (12 months)
Interventions
Paroxetine 20 mgs daily as oral capsule for 4 months. Adherence and side efects will be monitered by weekly phone calls for first 4 weeks. At the end of 4 months participants will also be asked to return any capsules if remaining to assess overall adherence.
Sponsors
Department of Respiratory Medicine, TQEH
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients with: COPD, as confirmed by lung function testing ie FEV1/FVC <0.70, and Anxiety symptoms with Beck Anxiety Inventory (BAI) score of >15.
Exclusion criteria
Severe cognitive impairment. Terminal cancer. Pregnancy and lactation. Unstable psychiatric condition like schizephrenia or active suicidal ideation. Current use of MAOinhibitors. Intolerance or allergy to SSRIs. Prolonged QT interval on ECG. Current acute exacerbation of COPD Current use of regular antianxiety and antidepressant medications.
Outcome results
None listed