behavioural and emotional problems and impairment of executive functioning due to acquired brain injury to the frontal lobes
Conditions
Interventions
Trade Name: symmetrel
Pharmaceutical Form: Capsule
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use
Sponsors
GGZ Oost Brabant
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 40 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Brain injury due to different causes is common and can have severe functional impact. Frontal lesions often lead to cognitive impairments, but also to behavioural consequences, e.g. apathy, agitation, aggression, and emotional lability. Amantadine may be effective in the treatment of these cognitive and behavioural consequences. Anatomical and neurochemical theory support these findings and amantadine is clinically used albeit without the support of scientific evidence. The aim of this study is to find scientific evidence to support the clinical use of amantadine in the brain injured.;Secondary Objective: not applicable;Timepoint(s) of evaluation of this end point: 17 weeks after the start of the study the end points will be evaluated; Primary end point(s): The main study parameters will be the behavioural disturbance and the impairment in executive functioning due to the brain injury involved. The behavioural problems will be measured on the one hand with a standardized instrument (the Neuropsychiatric Inventory (NPI)); on the other hand we will establish an individual target behaviour in cooperation between the investigator, the patient and the significant other. This individual target behaviour will be the most problematic behaviour for the patient or his environment, and will be measured by a Visual Analogue Scale (VAS), scoring by severity on a 1-100 scale. Individual target behaviours could for example be the number of aggressive incidents per day, apathy or sexual inappropriate behaviour. The VAS is particularly suitable for the assessment of subjective phenomena. [43] Nijman et al used a VAS to measure the severity of aggressive incidents on psychiatric wards. [44] Morrison used a VAS to allow relatives and professionals to rate the behaviour of elderly patients. He proved the scale to have good inter-rater reliability, test-retest reliability and validity.[45] | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: 17 weeks after the start of the study this endpoint will be evaluated.; Secondary end point(s): - Cognitive impairments (MMSE-24) The MMSE will be administered to measure objective cognitive impairments.[36] The MMSE consists of 21 items and is divided in two parts. All the items of the first part will be verbally answered. The verbal section measures memory, orientation and attention domains. The second part of the MMSE subjects will have to name, read, write and copy. 30 Points is the maximum score that subjects can achieve.[36] The MMSE is proven to be valid and reliable.[36] The concurrent validity was proven good for as well the verbal scale as the performal scale of the Wechsler Adult Intelligence Scale (respectively r = .78 and r = .66).[37] The test-retest reliability of the MMSE was high (Pearson coefficient ranging from .83 till .98). | — |
Countries
Netherlands
Contacts
Public ContactOpleiding & Onderzoek
GGZ Oost Brabant
Outcome results
None listed