The influence of bupropion compared to placebo on the change of apathy as quantified by the apathy evaluation scale (AES-I, where I \[informant\] is a friend or family member familiar with the daily activities of the subject) in patients with HD after ten (10) weeks of treatment.
The safety and tolerability of Bupropion in HD. The influence of Bupropion compared to placebo on the: * change of apathy as quantified by the AES-C (clinician) or the AES-S (self), * change of motor symptoms (UHDRS) and quantitative grip force motor assessment, * change of cognitive symptoms (UHDRS and MMSE), * change of psychiatric symptoms (UHDRS, HADS), * change of activities of daily living (UHDRS), * change of the NPI caregivers' distress score (NPI-D), * change of ventral striatal and ventromedial prefrontal activation in response to a reward paradigm as quantified by fMRI.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
40
Crossover design: Oral administration of 150 mg bupropion once daily for 2 weeks, followed by 300 mg bupropion once daily for subsequent 8 weeks, tapering: 150 mg bupropion once daily for 7 days
Crossover design: Oral administration of placebo once daily for 2 weeks, followed by placebo once daily for subsequent 8 weeks, tapering: placebo once daily for 7 days
Neurologische Klinik der Ruhr-Universität Bochum
Bochum, Germany
Universitätsklinikum Ulm, Klinik für Neurologie
Ulm, Germany
Apathy Evaluation Scale (AES-I)
The influence of Bupropion compared to placebo on the change of apathy as quantified by the apathy evaluation scale (AES-I, where I \[informant\] is a friend or family member familiar with the daily activities of the subject) in patients with HD after ten weeks of treatment.
Time frame: 10 weeks
AES-C (clinician)
The influence of Bupropion compared to placebo on the change of apathy as quantified by the apathy evaluation scale (AES-C, where C \[clinician\] is the trial investigator) in patients with HD after ten weeks of treatment.
Time frame: 10 weeks
AES-S (self)
The influence of Bupropion compared to placebo on the change of apathy as quantified by the apathy evaluation scale (AES-S, where S \[self\] is the patient) in patients with HD after ten weeks of treatment.
Time frame: 10 weeks
Motor symptoms (UHDRS)
The influence of Bupropion compared to placebo on the UHDRS motor score in patients with HD after ten weeks of treatment.
Time frame: 10 weeks
Quantitative grip force motor assessment
The influence of Bupropion compared to placebo on motor scores in patients with HD after ten weeks of treatment.
Time frame: 10 weeks
Cognitive Symptoms
The influence of Bupropion compared to placebo on MMSE in patients with HD after ten weeks of treatment.
Time frame: 10 weeks
Psychiatric symptoms
The influence of Bupropion compared to placebo on UHDRS behavioural assessment in patients with HD after ten weeks of treatment.
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Time frame: 10 weeks
Activities of daily living
The influence of Bupropion compared to placebo on UHDRS Functional Assessment in patients with HD after ten weeks of treatment.
Time frame: 10 weeks
Caregiver's distress
The influence of Bupropion compared to placebo on the NPI caregiver's distress score.
Time frame: 10 weeks
ventral striatal and ventromedial prefrontal activation
Change of ventral striatal and ventromedial prefrontal activation in response to a reward paradigm as quantified by fMRI.
Time frame: 10 weeks
Adverse events
The safety and tolerability of Bupropion will be compared with placebo in patients with HD after ten weeks of treatment.
Time frame: 10 weeks