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Sponsors and Collaborators: |
Carolinas Healthcare System Department of Education |
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Information provided by: | Carolinas Healthcare System |
ClinicalTrials.gov Identifier: | NCT00621751 |
The purpose of this study is to determine if carbamazepine reduces irritability and aggression among individuals with traumatic brain injury
Condition | Intervention |
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Traumatic Brain Injury |
Drug: Carbamazepine Drug: Placebo |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Carbamazepine for the Treatment of Chronic Post-Traumatic Brain Injury Irritability and Aggression: A 42-Day, Single-Site, Forced-Titration, Parallel Group, Randomized, Double-Blind, Placebo Controlled Trial |
Estimated Enrollment: | 74 |
Study Start Date: | February 2008 |
Estimated Study Completion Date: | November 2012 |
Estimated Primary Completion Date: | November 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Experimental
Carbamazepine 800 mg daily
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Drug: Carbamazepine
800 mg daily
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B: Placebo Comparator
Placebo
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Drug: Placebo
Placebo
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It is anticipated that 74 subjects with 74 corresponding subject informants will be recruited at Carolinas Rehabilitation. Subjects will be recruited from the clinic at Carolinas Rehabilitation. Subjects will also be referred by psychiatrists at North Carolina Neuropsychiatry.
Subjects who consent and qualify will be randomized in a 1:1 ratio to Tegretol® or placebo. Stratification to randomization group will occur based on the presence of depression defined by a BDI-II score ≥ 13. Subjects randomized to active drug will be titrated up in dose, as tolerated, over a period of 3 weeks. Starting dose is 200mg twice daily to 200mg three times daily to 200mg, 2 tabs, twice daily. There will be 3 clinic visits. Visits will occur at baseline for consenting and screening, day 28, and day 42. Follow up phone calls will occur each week that the subject is not seen in the clinic until the end of the study. Follow up phone calls will assess for study medication compliance, adverse events and concomitant medication changes. Day 42 ends the period of the Randomized Clinical Trial phase of the study and the subjects will begin the 1 week of taper of Tegretol® at 400mg daily and then stop drug. A safety phone call will be made at day 49.
The following questionnaires will be used as measures of irritability for the subject and the informant: Neuropsychiatric Inventory (NPI), State Trait Anger Expression Inventory (STAXI-2), and Global Impression of Change. The following 3 questionnaires will be dispensed to the subject only: Beck Depression Inventory, Brief Symptom Inventory, and Fatigue Impact Scale. The Investigator will complete the Clinical Global Impression of change at Visits 2 and 3.
History and Physical Exam, hematology, chemistry, including renal and liver function studies will be obtained for safety and tolerability. Serum pregnancy tests will be drawn at screening for females of childbearing potential. Carbamazepine levels will be drawn at visits 2 and 3.
Ages Eligible for Study: | 16 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Marybeth Whiney, R.N. | 704-355-1409 | marybeth.whitney@carolinashealthcare.org |
Contact: Flora M Hammond, M.D. | 704-355-9330 | flora.hammond@carolinashealthcare.org |
United States, North Carolina | |
Carolinas Rehabilitation | Recruiting |
Charlotte, North Carolina, United States, 28203 | |
Contact: Marybeth Whitney, R.N. 704-355-1409 marybeth.whitney@carolinashealthcare.org | |
Contact: Flora Hammond, M.D. 704-355-9330 flora.hammond@carolinashealthcare.org | |
Principal Investigator: Flora M Hammond, M.D | |
Sub-Investigator: Timothy P Young, M.D. | |
Sub-Investigator: Lori M Grafton, M.D. |
Responsible Party: | Carolinas HealthCare System ( Flora Hammond, M.D. ) |
Study ID Numbers: | 12-07-02A, NIDRR H133A |
Study First Received: | February 13, 2008 |
Last Updated: | October 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00621751 |
Health Authority: | United States: Institutional Review Board |
Brain Injury Irritability Aggression Irritability and aggression among individuals with traumatic brain injury |
Craniocerebral Trauma Carbamazepine Wounds and Injuries Disorders of Environmental Origin Central Nervous System Diseases |
Trauma, Nervous System Brain Diseases Aggression Brain Injuries Behavioral Symptoms |
Tranquilizing Agents Nervous System Diseases Physiological Effects of Drugs Psychotropic Drugs Central Nervous System Depressants Antimanic Agents Pharmacologic Actions |
Analgesics, Non-Narcotic Sensory System Agents Therapeutic Uses Analgesics Peripheral Nervous System Agents Central Nervous System Agents Anticonvulsants |