Efficacy of sertraline for palliative management of refractory breathlessness

Phase 3

Completed

• Conditions: Intractable dyspnoea; Respiratory - Other respiratory disorders / diseases

• Registration Number: ACTRN12610000464066
• Lead Sponsor: Flinders University

Brief Summary

Chronic breathlessness generates suffering late in life. In this setting, titrated sertraline had similar benefits and harms to placebo in an adequately powered, multi-site, double blind, randomised controlled trial at four weeks.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-06-08
• Study Completion: 2017-01-16
• Last Update Posted: 5 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

Adults (age >18)
Refractory dyspnoea where the underlying cause of the dyspnoea has been maximally treated. Refractory dyspnoea does not have a minimum duration and can have been present for any period of time. A medical specialist must document that all identified reversible causes of the dyspnoea are being optimally managed
Breathlessness of a level 3 or higher on the Modified Medical Research Council (MRC) dyspnoea scale
On stable medications for breathlessness over the prior week except routine as needed” medications
Prognosis of at least 2 months in the opinion of the treating clinician
English-speaking and able to read study questionnaires (5th grade level)
Able to provide informed consent

Exclusion Criteria

1. Previous adverse reaction to sertraline
2. History of severe hepatic impairment defined as Childs Pugh Class of ‘C’ (score of 11 to 15)
3. Gastro-intestinal bleeding within the previous six months
4. Serum sodium less than 128mmol/l
5. Recent difficulty with seizure control
6. Evidence of respiratory depression with resting respiratory rate <8
7. Active respiratory or cardiac event in the previous week, not including upper respiratory tract infections. Illness must be resolved for at least 1 week prior to baseline evaluation, as judged by a doctor involved in the care of the person
8. Documented previous respiratory failure induced by any opiate medication
9. Pregnant or breastfeeding
10. Unable to give informed consent or complete diary entries
11. Depressive symptomology or suicidality (HADS depression subscale >16)
12. Current therapy with any one of the following medications due to the risk of serotonin syndrome: any selective serotonin reuptake inhibitor (SSRI); any serotonin-norepinephrine reuptake inhibitor (SNRI); noradrenergic and specific serotonergic antidepressant (NaSSA); any serotonin receptor agonist; any tricyclic antidepressant; any monoamine oxidase inhibitor (MAOI) or who have been taking non-reversible monoamine oxidase inhibitors within 4 weeks prior to study entry or reversible MAOIs within 2 days of study entry; Buspirone; Lithium; Carbamazepine; Linezolid; Imatinib; Amphetamine type drugs (dexamphetamine, methylphenidate); Weight loss drugs (phenteramine, diethylpropion, sibutramine); Over the counter medications (dextromethorphan, chlorpheniramine, and bropheniramine); Complementary medicines- St Johns Wort, tryptophan, S-adenosyl-methionine (SAME);

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in the current sensation of breathlessness using a 100mm Visual Analogue Scale and a 4 point likert scale.[ Assessed at baseline (morning and evening), daily in the morning and evening of days 26, 27 and 28, and at study exit. Average of morning and evening scores over the last three days (day 26, 27 and 28) will determine response.]