Abstract
ObjectiveTo evaluate the efficacy and safety of bupropion in the treatment of apathy in Huntington’s disease (HD).MethodsIn this phase 2b multicentre, double-blind, placebo-controlled crossover trial, individuals with HD and clinical signs of apathy according to the Structured Clinical Interview for Apathy—Dementia (SCIA-D), but not depression (n = 40) were randomized to receive either bupropion 150/300mg or placebo daily for 10 weeks. The primary outcome parameter was a significant change of the Apathy Evaluation Scale (AES) score after ten weeks of treatment as judged by an informant (AES-I) living in close proximity with the study participant. The secondary outcome parameters included changes of 1. AES scores determined by the patient (AES-S) or the clinical investigator (AES-C), 2. psychiatric symptoms (NPI, HADS-SIS, UHDRS-Behavior), 3. cognitive performance (SDMT, Stroop, VFT, MMSE), 4. motor symptoms (UHDRS-Motor), 5. activities of daily function (TFC, UHDRS-Function), and 6. caregiver distress (NPI-D). In addition, we investigated the effect of bupropion on brain structure as well as brain responses and functional connectivity during reward processing in a gambling task using magnetic resonance imaging (MRI).ResultsAt baseline, there were no significant treatment group differences in the clinical primary and secondary outcome parameters. At endpoint, there was no statistically significant difference between treatment groups for all clinical primary and secondary outcome variables. Study participation, irrespective of the intervention, lessened symptoms of apathy according to the informant and the clinical investigator.ConclusionBupropion does not alleviate apathy in HD. However, study participation/placebo effects were observed, which document the need for carefully controlled trials when investigating therapeutic interventions for the neuropsychiatric symptoms of HD.Trial registrationClinicalTrials.gov 01914965
Highlights
Apathy is a common behavioral syndrome in neuropsychiatric disorders with prefrontal cortex (PFC) and basal ganglia (BG) pathology, such as Huntington’s disease (HD) [1, 2]
Data Availability Statement: An excerpt of the data that will allow full analysis of all results shown in the manuscript except for patient-relevant data that are protected by confidentiality regulations are available on request by contacting Lisanne Mutze at the European Huntington’s Disease Network (EHDN) Scientific and Bioethics Advisory Committee (SBAC) at actionhd_datarequest@euro-hd.net
Apathy Evaluation Scale (AES) scores determined by the patient (AES-S) or the clinical investigator (AES-C), 2. psychiatric symptoms (NPI, HADS-SIS, Unified Huntington’s Disease Rating Scale (UHDRS)-Behavior), 3. cognitive performance (SDMT, Stroop, VFT, Mini-Mental State Examination (MMSE)), 4. motor symptoms (UHDRS-Motor), 5. activities of daily function (TFC, UHDRS-Function), and 6. caregiver distress (NPI-D)
Summary
To evaluate the efficacy and safety of bupropion in the treatment of apathy in Huntington’s disease (HD). Data Availability Statement: An excerpt of the data that will allow full analysis of all results shown in the manuscript except for patient-relevant data that are protected by confidentiality regulations are available on request by contacting Lisanne Mutze at the EHDN Scientific and Bioethics Advisory Committee (SBAC) at actionhd_datarequest@euro-hd.net
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