Amantadine for Treatment of Symptoms of the Post-Traumatic Confusional State
Information source: Methodist Rehabilitation Center
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Traumatic Brain Injury; Posttraumatic Confusional State; Delirium
Intervention: Amantadine hydrochloride (Drug); Placebo capsule (Drug)
Phase: Phase 4
Status: Active, not recruiting
Sponsored by: Methodist Rehabilitation Center Official(s) and/or principal investigator(s):
Stuart A Yablon, M.D., Principal Investigator, Affiliation: Brain Injury Program, Methodist Rehabilitation Center
Mark Sherer, Ph.D., Study Director, Affiliation: Department of Research, Memorial Hermann/TIRR, Houston, TX
Risa N Richardson, Ph.D., Study Director, Affiliation: Polytrauma Program, James A. Haley Veterans Hospital, Tampa, FL
Summary
Patients with traumatic brain injury often experience a period of acute confusion that may
include agitation as they recover from their injuries. While this confusion generally
resolves with time, patients may pose increased risk of injury to themselves or others during
this period. Their behavior may also increase stress for family members and interfere with
their ability to benefit from rehabilitation therapies. A number of different medications
have been used to treat confusion to decrease agitation, decrease risk of injury, and improve
participation in rehabilitation therapies. To this point, there has not been a research or
scientific basis for knowing which medication is the best for a specific patient. The
overall goal of this study is to conduct a scientific investigation to help determine which
medication works best to treat confusion.
Study hypothesis: Amantadine will reduce the severity and number of symptoms of acute
confusion after traumatic brain injury.
Clinical Details
Official title: Amantadine Hydrochloride for Treatment of Symptoms of the Post-Traumatic Confusional State Among Neurorehabilitation Admissions With TBI: A Randomized, Double-Blind, Placebo-Controlled Trial
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: Confusion Assessment Protocol (number of symptoms)
Secondary outcome: number of participants withdrawn from study due to fulfillment of "escape criteria"Time to reach "non-confused" Confusion Assessment Protocol score
Detailed description:
Patients with TBI who require inpatient rehabilitation are frequently confused at the time of
admission for rehabilitation. Our investigations of confusion conducted as part of the
TBIMSM have clarified the nature of confusion in early recovery after TBI. Early confusion
(PTCS) has been found to be a complex syndrome characterized by disorientation, cognitive
impairment, restlessness, decreased level of daytime arousal, sleep disturbance, fluctuation
of symptoms, and psychotic-type symptoms. PTCS complicates early management of patients with
TBI, and may contribute to increased risk of injury to patients and hospital staff, increased
stress among family members and staff, decreased participation in therapies, increased cost
of care, and an increased likelihood of being discharged to psychiatric or long-term care
settings. These facts indicate the need for effective management of PTCS. Consensus
regarding optimal treatment of the cognitive and behavioral symptoms encountered among
patients with PTCS does not exist currently. While many agents have been tried to address
such symptoms in TBI, few have been investigated systematically. These circumstances
indicate the need for appropriate clinical trials to provide guidance to clinicians for
medical treatment of PTCS. In response, the NIDRR-Traumatic Brain Injury Model System of
Mississippi proposed a randomized, double-blinded, placebo-controlled, parallel group trial
for the pharmacological treatment of PTCS. The agent selected for this clinical trial is
amantadine, an NMDA and indirect dopamine agonist. This agent will be compared to placebo on
response measures of efficacy and safety.
Study hypothesis: Amantadine will reduce the severity and number of symptoms of PTCS.
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Acute Traumatic Brain Injury (≤90 days postinjury)
- Responsive (not fulfilling criteria for Minimally Conscious State)
- Meet PTCS criteria on 2 consecutive examinations (as determined by the Confusion
Assessment Protocol)
- Initial neurorehabilitation hospital admission
- Anticipated ≥2 week length-of-stay after meeting PTCS criteria
Exclusion Criteria:
- Preexisting seizure disorder
- Prior history of hospitalization for psychiatric condition
Locations and Contacts
Methodist Rehabilitation Center, Jackson, Mississippi 39216, United States
Additional Information
Related publications: Sherer M, Yablon SA, Nakase-Richardson R, Nick TG. Effect of severity of post-traumatic confusion and its constituent symptoms on outcome after traumatic brain injury. Arch Phys Med Rehabil. 2008 Jan;89(1):42-7. Nakase-Richardson R, Yablon SA, Sherer M. Prospective comparison of acute confusion severity with duration of post-traumatic amnesia in predicting employment outcome after traumatic brain injury. J Neurol Neurosurg Psychiatry. 2007 Aug;78(8):872-6. Epub 2006 Dec 18. Sherer M, Nakase-Thompson R, Yablon SA, Gontkovsky ST. Multidimensional assessment of acute confusion after traumatic brain injury. Arch Phys Med Rehabil. 2005 May;86(5):896-904. Nakase-Thompson R, Sherer M, Yablon SA, Nick TG, Trzepacz PT. Acute confusion following traumatic brain injury. Brain Inj. 2004 Feb;18(2):131-42.
Starting date: April 2003
Ending date: June 2008
Last updated: June 5, 2008
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