Efficacy of amantadine on behavioural and emotional problems and impairment of executive functioning due to acquired brain injury to the frontal lobes: a series of single case experimental design studies.
- Conditions
- acquired brain injury1002930510037173
- Registration Number
- NL-OMON45205
- Lead Sponsor
- GGZ Oost Brabant (Rosmalen)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 40
* Subjects have suffered acquired brain damage due to various aetiologies as verified by CT or MRI
* Subjects suffer from emotional lability/irritability, aggressiveness, apathy as established through clinical observation and/or impairment of executive functioning as established by clinical judgement or on the basis of neuropsychological assesment.
* Subjects are >3 months post injury
* Subjects are 18 years or older
* Written informed consent is given
* Current drug addiction
* Current psychoses
* The current use of incompatible medications: methylphenidate, typical or atypical antipsychotics, combination diuretics (hydrochlorthiazide + potassium sparing diuretics) or Levodopa.
* Pregnancy and lactation
* Cardiac disease. Inclusion only after the consulting cardiologists consent
* Refractory epilepsy
* Kidney failure (eGFR<10 ml/min)
* A history of gastric ulceration
* Current glaucoma
* Hypersensitivity to amantadine or any of the excipients
. Suicidality
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Main study parameters/endpoints:<br /><br>* The behavioural problems: emotional lability/irritability, aggression, and<br /><br>apathy will be measured by the Neuro Psychiatric Inventory (NPI).<br /><br>* Individual target behaviour will be established and measured by a Visual<br /><br>Analogue Scale (VAS (1-100)).<br /><br>* The impairment of executive functioning is measured by the Behaviour Rating<br /><br>Inventory of Executive Function-A (BRIEF-A) </p><br>
- Secondary Outcome Measures
Name Time Method <p>Cognitive impairments as measured by the Mine Mental State Examination (MMSE)</p><br>