Status:
COMPLETED
Amitriptyline to Prevent Headache After Traumatic Brain Injury
Lead Sponsor:
University of Washington
Conditions:
Brain Injuries
Post-Traumatic Headache
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
Brief Summary
The investigators propose to conduct a 2-arm, open-label pilot study to determine if early treatment with amitriptyline will decrease the frequency and severity of headaches after mild traumatic brain...
Detailed Description
Research Hypothesis and Aims: The ultimate aim of this research is to determine whether early treatment using amitriptyline can prevent the development of chronic headache after TBI. This proposal is ...
Eligibility Criteria
Inclusion
- Acute mild TBI (Glasgow Coma Scale of 13-15 on emergency department evaluation, any period of loss of consciousness (LOC) \< than 30 minutes, alteration of consciousness or post-traumatic amnesia (not to exceed 24 hours)
- Ability to give consent
- Ages 18-60
- Access to a telephone
- Current headache (new headache or headache worse than prior to injury)
Exclusion
- Does not speak English
- Diagnosed seizure disorder
- Myocardial infarction in prior 6 months
- Cardiac arrhythmia requiring medication treatment
- Prolonged Q-T interval on electrocardiogram
- Psychosis
- Intoxication on hospital admission sufficient enough to cloud the diagnosis of mild TBI
- Incarceration or homelessness
- Allergy to amitriptyline
- Current treatment with amitriptyline or other tricyclic antidepressant
- Currently taking any medication not recommended for use with amitriptyline due to the potential for Q-T interval prolongation. Examples of this include: Class I, I-A or II antiarrhythmics, TCA's, MAOI's, selected fluoroquinolones (gatifloxacin, moxifloxacin), selected antipsychotic medications (haloperidol, risperidone, quetiapine), selected antiretroviral medications, cisapride, chloroquine, chlorpromazine, prochlorperazine, promethazine, citalopram, fluoxetine, erythromycin, methadone
- History of glaucoma
- History of prostate disease or current urinary retention
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2016
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT01856270
Start Date
April 1 2013
End Date
February 1 2016
Last Update
September 19 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Harborview Medical Center
Seattle, Washington, United States, 98109