Overview

Carbamazepine for the Treatment of Chronic Post-Traumatic Brain Injury Irritability and Aggression

Status:
Completed
Trial end date:
2013-10-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to determine if carbamazepine reduces irritability and aggression among individuals with traumatic brain injury
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Atrium Health
Carolinas Healthcare System
Collaborator:
U.S. Department of Education
Treatments:
Carbamazepine
Criteria
Inclusion Criteria:

- Closed head injury (defined as impaired brain function resulting from externally
inflicted trauma without penetrating injury) at least 6 months prior to enrollment

- Age at time of enrollment: 16 to 75 years

- Voluntary informed consent of patient and informant

- Subject and informant willing to comply with the protocol

- Informant-rated NPI Irritability Domain score 6 or greater to include only
moderate-severe irritability

- Medically and neurologically stable during the month prior to enrollment If taking
antidepressant, anxiolytic, hypnotic, or stimulant medications, no change anticipated
in these medications during the month prior to enrollment No change in therapies or
medications planned during the 42-day participation No surgeries planned during the
42-day participation Vision, hearing, speech, motor function, and comprehension
sufficient for compliance with all testing procedures and assessments

- Informant (e.g. family member or close friend) with daily interaction in order to
observe occurrences of irritability

Exclusion Criteria:

- Potential subject without a reliable informant

- Penetrating head injury

- Injury < 6 months prior to enrollment

- Ingestion of carbamazepine during the month prior to enrollment

- Inability to interact sufficiently for communication with caregiver

- Acute and rehabilitation records unavailable or incomplete

- Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV) diagnosis of
schizophrenia or psychosis

- Diagnosis of progressive or additional neurologic disease

- Clinical signs of active infection

- Creatinine clearance <60 mL/min

- Liver function tests > 2x normal values

- Pregnancy; lactating females; sexually active females who do not agree to use birth
control

- Hormonal birth control as only means of birth control if sexually active and of child
bearing age potential due to carbamazepine effect of lowering hormone levels, and
potentially effectiveness

- Concurrent use of the following medicines due to potential for drug interaction:
macrolides, rifabutin, doxycycline, nicoumalone, warfarin, fluoxetine, fluvoxamine,
viloxazine, nefazodone, tricyclic and tetracyclic antidepressants, clobazam,
clonazepam, lamotrigine, phenytoin, sodium valproate, tigabine and topiramate,
phenobarbitone, primidone, chloroquine and mefloquine, antipsychotics, indinavir,
nelfinavir, saquinavir, ritonavir, diltiazem, verapamil, felodipine, isradipine,
nicardipine, nifedipine, cimetidine, cyclosporins, corticosteroids, gestrinone and
toremifene, danazol, tibolone

- Suicidal ideation

- Concurrent use of Monoamine Oxidase Inhibitors or ingestion of within 2 weeks before
starting study

- Hypersensitivity/allergy to carbamazepine, any of the ingredients in carbamazepine, or
any structurally related drugs (e.g. the tricyclic antidepressants)

- History of liver failure or hepatitis

- History of renal failure

- History atrio-ventricular conduction abnormalities unless paced

- History of bone marrow depression

- History of porphyria

- Asian heritage