Genetic Determinants of Amitriptyline Efficiency for Pain Treatment
CompletedPhase 4NCT02256943
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
Low dose tricyclic antidepressant drugs are routinely administered co-analgesics in pain medicine. Amitriptyline is largely considered as a gold standard. Amitriptyline underlies cytochrome CYP2D6 and CYP2D19 metabolism. CYP2D6 is highly polymorphic; numerous genetic variants result in 4 major classes characterizing enzymatic activity: poor metabolizers, intermediate metabolizers, extensive metabolizers and ultrarapid metabolizers. It is not known to which extent metabolizer classes determine pain outcomes or side-effects. As only one in three pain patients is considered to be a responder to amitriptyline's co-analgesic effect, prediction of treatment efficacy with a fast and easy to perform bedside test may contribute to the patients quality of life. The aim of this study is to determine the influence of cytochrome variants on experimental pain, drug related side-effects and finally identification of active metabolites.
Study details
- Official title
- Effects of Amitriptyline on Central Pain Processing in Healthy Volunteers Depending on CYP Pharmacogenetics
- Conditions
- Interventions
- Drug: Amitriptyline
- Drug: Tolterodine
- Sponsor
- Insel Gruppe AG, University Hospital Bern
- Collaborators
- University of Washington; Ludwig-Maximilians - University of Munich; Aalborg University
- Start date
- 2014-11
- Primary completion
- 2018-05
- Sex
- Male
- Age range
- from 18 Years to 65 Years
- Healthy volunteers
- true
- Results posted
- No results posted in this snapshot
- Countries
- Switzerland
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Healthy * Male * \>7 Metabolic Equivalents * Written informed consent Exclusion Criteria * Chronic pain syndrome * Drug abuse * Alcohol abuse * Suspicion of neurologic dysfunction at tested sites * Ongoing treatment with antidepressants * Ongoing treatment with analgesics * Pretreatment with any CYP3A inducers or inhibitors * Known allergy to tested drugs * Elevated eye pressure * Obstructive uropathy * Heart disease * Pulmonary disease * Neurological disease * Psychiatric illness
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT02256943