Shingles Infections and Infestations Zoster [herpes zoster]
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adults aged =50 years 2. Clinical diagnosis of herpes zoster (HZ) 3. Rash onset <144 hours
Exclusion criteria
Exclusion criteria: 1. Inability to give informed consent 2. Third or more episode of herpes zoster 3. Known adverse reaction to amitriptyline or contraindications (monoamine oxidase inhibitors) 4. Current/recent (within previous two weeks) use of a tricyclic antidepressant 5. Prolonged QT interval or concomitant drugs that prolong the QT interval 6. Suicidal ideation 7. Heart block 8. Recent myocardial infarction (<4 weeks) 9. Immunosuppression 10. Significant bradycardia 11. Uncompensated heart failure 12. Hyperthyroidism 13. Severe liver disease 14. Phaeochromocytoma 15. Urinary retention 16. If female; current or planned (in next 3 months) pregnancy or breastfeeding 17. Currently (or recently, within the previous 4 months) enrolled in another CTIMP
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Presence/absence of postherpetic neuralgia measured using a cut-off of =3/10 on numerical rating scale average pain in last 24 hours; Timepoint(s): 90 days after rash onset | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The safety, tolerability and acceptability of amitriptyline assessed using patient-completed medication use, problems and hospitalisation sections of questionnaire at 30, 60 and 90 days, and by direct report by participant or clinician 2. Masking of participants assessed using the bang binding index in patient questionnaires at 30, 60 and 90 days post rash onset 3. Shorter and longer-term outcomes of pain, quality of life, mental well-being and frailty, assessed using the Zoster Brief Pain Inventory (ZBPI), 9-item patient health questionnaire (PHQ-9), 7-item general anxiety disorder questionnaire (GAD-7) and Tilburg Frailty Indicator, at 0, 90, 180 and 360 days post rash onset 4. The cost-effectiveness of low dose amitriptyline to placebo for the prevention of PHN using EQ-5D-5L and patient-completed healthcare resource use questions at 0, 90, 180 and 360 days post rash onset, and GP electronic medical records for the 12-month study period 5. Use of healthcare resources and analgesics assessed using patient-completed medication and healthcare resource use questions at 90, 180 and 360 days post rash onset, and GP electronic medical records for the 12-month study period | — |
Countries
England, United Kingdom