N/A
N=70
Carbamazepine for the Treatment of Chronic Post-Traumatic Brain Injury Irritability and Aggression
Traumatic Brain Injury
Bottom Line
View on ClinicalTrials.gov: NCT00621751 ↗Enrolled (actual)
70
Serious AEs
10.0%
Results posted
Aug 2021
Primary outcome: Primary: Neuropsychiatric Inventory Irritability-Aggression Domains Composite Measure -- Observer — 37.7; 36.7 score on a scale — p=0.60
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Carbamazepine (Drug); Placebo (Drug)
- Age
- Pediatric, Adult, Older Adult · 16+ yrs
- Sex
- All
- Sponsor
- Wake Forest University Health Sciences
- Primary completion
- Sep 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Neuropsychiatric Inventory Irritability-Aggression Domains Composite Measure -- Observer |
37.7; 36.7 | 0.60 |
| SECONDARY Proportion of Participants With Minimal Clinically Important Difference -- Observer Rating |
20; 26 | < .05 sig |
| SECONDARY Global Impression of Change -- Observer |
3.3; 3.1 | — |
| SECONDARY Neuropsychiatric Inventory Irritability-Aggression Domains Composite Measure Completed by Participant [Time Frame: 42 Days] |
37.5; 36.4 | — |
| SECONDARY Proportion of Participants With Minimal Clinically Important Difference (MCID) -- Participant |
21; 16 | — |
| SECONDARY Clinicians Global Impression of Change |
3.1; 2.9 | — |
| SECONDARY Global Impression of Change -- Participant |
3.1; 3.1 | — |
Summary
The purpose of this study is to determine if carbamazepine reduces irritability and aggression among individuals with traumatic brain injury
Eligibility 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 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
Data sourced from ClinicalTrials.gov (NCT00621751). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.