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Can taking amitriptyline tablets stop long-term pain from shingles?

Amitriptyline for the prevention of post-herpetic neuralgia

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN14490832
Enrollment
846
Registered
2022-01-27
Start date
2022-03-30
Completion date
Unknown
Last updated
2026-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Shingles Infections and Infestations Zoster [herpes zoster]

Interventions

Amitriptyline 10 mg tablets (or matched placebo tablet), increasing in 10 mg steps over 2 weeks as tolerated, to 30 mg maximum per day, for 70 days. Total follow-up is 12 months, with participant sur

Sponsors

University of Bristol
Lead Sponsor

Eligibility

Sex/Gender
All
Age
50 Years to 100 Years

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

MeasureTime 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

MeasureTime 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

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Apr 17, 2026