Utility of Amantadine Hydrochloride in the Treatment of Post-traumatic Irritability
NCT ID: NCT00627250
Last Updated: 2022-04-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
76 participants
INTERVENTIONAL
2003-03-31
2007-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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A
Amantadine 100 mg every morning and 12 noon
Amantadine
Amantadine 100 mg every morning and 12 noon
B
Placebo tablet every morning and 12 noon
Amantadine
Amantadine 100 mg every morning and 12 noon
Interventions
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Amantadine
Amantadine 100 mg every morning and 12 noon
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age at time of enrollment: 16 - 65 inclusive (i.e., on or after 16th birthday, up to day before 66th birthday).
* Voluntary informed consent of patient and informant.
* Subject and informant willing to comply with the protocol, \& are available for all scheduled clinic visits.
* Neuropsychiatric Inventory (NPI) Irritability Domain score \> 2.
* 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 28-day participation.
* No surgeries planned during the 28-day participation.
* Vision, hearing, speech, motor function, and comprehension must be sufficient for compliance with all testing procedures. Ability to interact and verbalize sufficient to participate in assessments.
* Informant (family member or close friend) who lives with the participant with daily interaction in order to observe occurrences of irritability.
Exclusion Criteria
* Penetrating head injury
* Injury \< 6 months prior to enrollment
* Inability to interact sufficient for communication with caregiver
* Acute and rehabilitation records unavailable or incomplete
* DSM-IV diagnosis of schizophrenia or psychosis
* Diagnosis of progressive or additional neurologic disease (such as, Alzheimer's disease, parkinson's disease, multi-infarct dementia, other cerebrovascular disorders with dementia, prior cerebrovascular accident, Huntington's disease, olivopontocerebellar atrophy, multisystem atrophy, multiple sclerosis, ALS, CNS tumor, progressive supranuclear palsy).
* Diagnosis of seizure in the month prior to enrollment.
* Previous allergy or adverse reaction to study drug
* Ingestion of amantadine hydrochloride during the month prior to enrollment.
* Concomitant use of neuroleptic agents or phenelzine
* Creatinine clearance \<60
* Pregnancy (Beta-HCG performed on all females of child-bearing potential) and lactating females.
* Clinical signs of active infection
16 Years
65 Years
ALL
No
Sponsors
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U.S. Department of Education
FED
Wake Forest University Health Sciences
OTHER
Responsible Party
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Principal Investigators
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Flora M Hammond, M.D.
Role: PRINCIPAL_INVESTIGATOR
Carolinas Rehabilitation
References
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Gualtieri T, Chandler M, Coons TB, Brown LT. Amantadine: a new clinical profile for traumatic brain injury. Clin Neuropharmacol. 1989 Aug;12(4):258-70. No abstract available.
HERRMANN EC Jr, GABLIKS J, ENGLE C, PERLMAN PL. Agar diffusion method for detection and bioassay of antiviral antibiotics. Proc Soc Exp Biol Med. 1960 Mar;103:625-8. doi: 10.3181/00379727-103-25617. No abstract available.
Schwab RS, England AC Jr, Poskanzer DC, Young RR. Amantadine in the treatment of Parkinson's disease. JAMA. 1969 May 19;208(7):1168-70. No abstract available.
Beers SR, Skold A, Dixon CE, Adelson PD. Neurobehavioral effects of amantadine after pediatric traumatic brain injury: a preliminary report. J Head Trauma Rehabil. 2005 Sep-Oct;20(5):450-63. doi: 10.1097/00001199-200509000-00006.
Gianutsos G, Chute S, Dunn JP. Pharmacological changes in dopaminergic systems induced by long-term administration of amantadine. Eur J Pharmacol. 1985 Apr 16;110(3):357-61. doi: 10.1016/0014-2999(85)90564-3.
Aoki FY, Sitar DS. Clinical pharmacokinetics of amantadine hydrochloride. Clin Pharmacokinet. 1988 Jan;14(1):35-51. doi: 10.2165/00003088-198814010-00003.
Allen RM. Role of amantadine in the management of neuroleptic-induced extrapyramidal syndromes: overview and pharmacology. Clin Neuropharmacol. 1983;6 Suppl 1:S64-73. doi: 10.1097/00002826-198300061-00009. No abstract available.
Stone TW. Evidence for a non-dopaminergic action of amantadine. Neurosci Lett. 1977 May;4(6):343-6. doi: 10.1016/0304-3940(77)90181-1.
Weller M, Kornhuber J. A rationale for NMDA receptor antagonist therapy of the neuroleptic malignant syndrome. Med Hypotheses. 1992 Aug;38(4):329-33. doi: 10.1016/0306-9877(92)90027-a.
Riederer P, Lange KW, Kornhuber J, Danielczyk W. Pharmacotoxic psychosis after memantine in Parkinson's disease. Lancet. 1991 Oct 19;338(8773):1022-3. doi: 10.1016/0140-6736(91)91888-2. No abstract available.
Edby K, Larsson J, Eek M, von Wendt L, Ostergard B. Amantadine treatment of a patient with anoxic brain injury. Childs Nerv Syst. 1995 Oct;11(10):607-9. doi: 10.1007/BF00301001.
Chandler MC, Barnhill JL, Gualtieri CT. Amantadine for the agitated head-injury patient. Brain Inj. 1988 Oct-Dec;2(4):309-11. doi: 10.3109/02699058809150901.
Rosati DL. Early polyneuropharmacologic intervention in brain injury agitation. Am J Phys Med Rehabil. 2002 Feb;81(2):90-3. doi: 10.1097/00002060-200202000-00003.
Shiller AD, Burke DT, Kim HJ, Calvanio R, Dechman KG, Santini C. Treatment with amantadine potentiated motor learning in a patient with traumatic brain injury of 15 years' duration. Brain Inj. 1999 Sep;13(9):715-21. doi: 10.1080/026990599121269.
Schneider WN, Drew-Cates J, Wong TM, Dombovy ML. Cognitive and behavioural efficacy of amantadine in acute traumatic brain injury: an initial double-blind placebo-controlled study. Brain Inj. 1999 Nov;13(11):863-72. doi: 10.1080/026990599121061.
Van Reekum R, Bayley M, Garner S, Burke IM, Fawcett S, Hart A, Thompson W. N of 1 study: amantadine for the amotivational syndrome in a patient with traumatic brain injury. Brain Inj. 1995 Jan;9(1):49-53. doi: 10.3109/02699059509004571.
Zafonte RD, Watanabe T, Mann NR. Amantadine: a potential treatment for the minimally conscious state. Brain Inj. 1998 Jul;12(7):617-21. doi: 10.1080/026990598122386.
Related Links
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Related Info
Other Identifiers
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H133A020522
Identifier Type: -
Identifier Source: secondary_id
12-02-06A
Identifier Type: -
Identifier Source: org_study_id
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